86 Communications Handbook for Clinical Trials

Transcription

1 Study staff/sidi Hadheld devices like GPS ad cellular telephoes are becomig critical tools i helpig to locate participats ad eter study data. 86 Commuicatios Hadbook for Cliical Trials

2 Chapter Preparig for ad Dissemiatig Study Results 6 Preparig to release your results should begi moths before the results of the study are kow. Ideally, dissemiatio should be cosidered durig the strategic commuicatios plaig process (see Chapter 3). Plaig ca esure that the study s results are uderstood by all iterested parties your trial participats, the ews media, ad appropriate atioal ad provicial govermet health officials. The time eeded for plaig will vary from study to study. For smaller sigle-site trials workig with oe istitutio, a basic dissemiatio pla could be outlied i a few hours ad the expaded with iput from staff members at the site, sposors, ad trusted parters. For more complex trials such as trials at multiple sites, coducted by differet istitutios i several coutries more detailed plas ad resources are usually ecessary. Such dissemiatio activities, ad the commuicatios ad media plaig that are part of sharig research results, are icreasigly recogized as essetial to the research edeavor. Advocates have become parters i dissemiatig results, ad they are a importat bridge betwee scietists ad civil society. Members of commuity advisory boards (CABs) ad eve trial participats ca help to shape messages, rather tha merely receive them. Some sposors ow allocate dissemiatio fudig directly to the sites for commuicatios ad media relatios. I this chapter I. The miimum package of dissemiatio activities II. III. IV. The dissemiatio team ad pla: compilig the core elemets Timig, timelies, ad time zoes Plaig for various outcome scearios V. Maagig embargoes ad prerelease issues VI. VII. Orchestratig the public aoucemet Post-aoucemet dissemiatio activities Elizabeth T. Robiso/FHI 87

3 I The miimum package of dissemiatio activities Oce your study has bee closed whether o schedule or uexpectedly the research results should be dissemiated to a variety of audieces through appropriate chaels, icludig publicatio i peer-reviewed jourals. This is a obligatio of the scietific commuity ad a key elemet i the collaborative research process (UNAIDS 2007; Emauel ad others 2004). Depedig o the situatio, the trial s sites may be resposible for certai dissemiatio activities, or sposors ad trial etworks may dictate how such activities are carried out. A miimum package of dissemiatio activities icludes: Iformatio sharig with study participats, CAB members, ad staff members at research sites ad other related trials i the area Formal otificatio to ethics committees, Miistries of Health, regulators, ad other govermet officials, key parters, ad sposors Outreach to leaders i the commuity where the research was coducted Outreach to other key stakeholders (trial etworks, health advocates) who are ivolved i related trials Distributio of materials that summarize the results to stakeholders of the trial Presetatio at scietific cofereces Publicatio of the results i a peer-reviewed joural To achieve impact, research eeds to both make the relevat iformatio accessible ad promote a eablig eviromet i which it ca be adopted. U.K. Departmet for Iteratioal Developmet (DFID), 2005 The cotets of the package will be determied by a umber of factors, icludig fudig, timig, ad huma resources. The uderlyig priciple is that stakeholders should be iformed as soo as the results are ready to be shared publicly. People should be able to locate your results years later i the public record, whether olie or i published archives. II The dissemiatio team ad pla: compilig the core elemets Whe plaig for the dissemiatio of the trial s results, you should revisit your iitial commuicatios strategy i light of specific eeds ad ay ew opportuities: Goal: What effect do you hope to achieve or to avoid? Audiece: Who will be iterested i or affected by your research results? Approach: What will be the most effective way to reach each group of stakeholders? Executio: Who will be resposible for carryig out dissemiatio activities ad whe (Ceter for Iterdiscipliary Research o AIDS: Commuity Research Core 2009)? 88 Commuicatios Hadbook for Cliical Trials

4 Take the followig steps to pla for the dissemiatio of your results. Step 1. Establish a dissemiatio plaig team ad a decisio-makig policy. May times, this small group will resemble the team that has bee ivolved i commuicatios throughout the trial, with possible additios of other stakeholders, such as a represetative of the orgaizatio that is sposorig the trial or a member of the CAB (see Chapter 2 o choosig your commuicatios team). Step 2. Determie how your team will make decisios. Oce the team is i place, discuss ad decide which members of the team will have the authority to make decisios. Who should review ad approve dissemiatio materials? Who will make key decisios about dissemiatio? Do certai members of the trial s staff have to review ad approve commuicatios that target specific audieces, such as govermet officials? What iput o decisios will site-level teams have withi trial etworks? How will urget decisios be made? These questios may have bee aswered i your iitial commuicatios strategy (see Chapter 3). If ot, put them o the ageda for your meetigs o the dissemiatio of results. Step 3. Discuss how you will release the results of your trial. Oce the team is i place, the members should begi discussig how to dissemiate the results. Well before the study cocludes ad before the team kows the results, the members should weigh the pros ad cos of differet release strategies, icludig the presetatio of prelimiary results at a scietific coferece or waitig util the results have bee published i a scietific joural. Aother strategy is to release the results directly to policymakers, the public, ad participats prior to publicatio or formal presetatio at a coferece. I such istaces, it is wise to seek alterative forms of peer review before the public release of the fidigs. I recommed that research teams hire a commuicatios staff perso other tha a study coordiator or ivestigator of record to maage dissemiatio. From my experiece, the latter are ofte too busy to do full justice to the commuicatios role. Keeth Kitu, Ivestigator/ Coordiator, The Makerere Uiversity- Johs Hopkis Uiversity Research Collaboratio, Ugada Whe assessig its optios, the team should establish its goals ad primary audieces, ad factor i ay special issues related to the timig of the public release. For example, some cofereces have strict embargo policies, which may hider the ability of the trial s sites to iform their participats ad local stakeholders util after the public release at the coferece. Cosider also whether the holiday seaso or the timig of major evets like the iteratioal football World Cup may affect your ability to reach stakeholders. (See Box 6.5 for more cosideratios whe selectig a coferece for the release of your results.) Step 4. Develop a writte dissemiatio pla with your team. Some teams prefer to write their plas i a arrative format that follows chroological steps. Others use grids to display at a glace specific audieces, activities geared to those audieces, people resposible for each 89

5 activity, ad deadlies. (See Box 6.1, which provides a template for a arrative pla.) Your team should decide o a format that will work best for your study. Step 5. Make sure that each site develops its ow pla. For multisite studies, each site should develop its ow pla based o the local eviromet, established relatioships, ad potetial for cotroversy. For example, i preparatio for the release of the results of the HPTN 039 study which ivestigated whether acyclovir (a drug that suppresses geital herpes) reduces the risk of a HIV ifectio i someoe with geital herpes each trial site filled i the template show i Box 6.1. (To dowload the template, click here.) Although these sites were ivolved i exactly the same study, the site i Johaesburg, South Africa, ad the site i Lima, Peru, developed differet plas for the dissemiatio of their results (see full arrative plas from both sites i Appedices 6.1 ad 6.2). Each pla respoded to local eeds ad opportuities, outlied a clear picture of how to proceed, ad demostrated creativity i the approaches that were used. For studies with multiple sites withi the same coutry, all of the sites should coordiate at Box 6.1. Template for researchers: how to pla for research dissemiatio Dissemiatio Pla for Itroductio ad backgroud iformatio Summarize i several paragraphs who is coductig the study, the purpose of the study, study methods, potetial outcomes, ad ay aspects of the research eviromet that might affect how study results will be uderstood, iterpreted, or accepted by both the commuity where the study was coducted ad other iterested parties. Dissemiatio activities Describe which methods you pla to use to reach key stakeholders with iformatio o your study, listig the dissemiatio activities ad eough detail for stakeholders to uderstad their purpose, timig, scope, ad feasibility. Pla commuicatios that target specific audieces Briefly outlie your pla to idetify ad commuicate with the followig groups: 90 Commuicatios Hadbook for Cliical Trials

6 a) Study staff/the research team b) Study participats c) Local study commuity d) Miistry of Health ad other govermet or regulatory officials e) Public health professioals ad the scietific commuity f ) Advocates ad other relevat civil society groups g) Doors h) News media Materials eeded to support your pla List the commuicatios materials that will eed to be writte ad distributed to support dissemiatio of the results (legth, laguage, target audiece). Staffig cosideratios Determie which staff members will be eeded to implemet the dissemiatio pla, especially after a trial has eded, whe commuity outreach workers ad others may o loger be o site. Evaluate the dissemiatio efforts Describe how you will assess ad documet the outcomes of your dissemiatio efforts. Pla ahead to promote access to ad use of fidigs If the study s fidigs have relevace for health care practices, programs, or policies, briefly describe your plas to facilitate access to ad use of the results: what will you do, why, with whom, ad how. 91

7 Box 6.2. Face-to-face meetigs at commuity level are most effective By Dr. Neetha Morar, Seior Scietist, HIV Prevetio Research Uit, Medical Research Coucil, Durba, South Africa Durig past aoucemets, we tried usig toll-free telephoe umbers that trial participats could call to receive the results. We were excited about usig a ew way to commuicate, but i the ed, few people chose to call. Istead, we foud that face-toface meetigs with the trial participats ad commuity stakeholders were the most effective ad most appreciated meas to commuicate results. This icluded visitig commuity stakeholders ad trial participats who were ot able to atted results meetigs. ready for them. the coutry level to esure cosistecy. Step 6. Decide i advace how to iform the study s participats ad make this a key elemet i your dissemiatio pla. Cosider strategies to prepare participats ad stakeholders for various potetial outcomes from the outset. Step 7. Whe developig your dissemiatio pla, remember to icorporate ay support especially techical assistace that you would like from commuicatios staff members who are ot at the trial site. If you are at a site, the commuicatios staff of the etwork or the sposorig uiversity or orgaizatio ca help you determie the type of support you will eed to prepare ad maage the dissemiatio. By ivolvig these people early, you allow them to build time ad resources ito their work plas so that they are ready for you whe you are Step 8. If you are a commuicatios perso charged with coordiatig dissemiatio activities from a headquarters or etwork level, it is equally importat to begi collaboratig early with staff members at the trial sites. Doig so will make delegatig tasks easier later, whe time becomes your most limited resource. If resources allow, etwork- or sposor-based commuicatios staff ca: Provide tailored o-site techical assistace to trial sites ad stakeholder groups upo request Develop materials that ca be adapted for local use by the sites Help develop ad distribute iformatio packets for specific atioal or iteratioal stakeholders Provide logistical support to local advocacy groups to tailor materials about trial results for their costituecies or audieces Help parters develop i-depth dissemiatio ad utilizatio plas targetig the iteratioal research commuity Provide istitutioal mechaisms for stakeholders to use i dissemiatig iformatio about trial results, such as space for local materials o a sposor s Web site Facilitate the developmet of case stories that exemplify the value of research processes 92 Commuicatios Hadbook for Cliical Trials

8 Health ceter, Ahero, Keya Silas Achar/FHI Box 6.3. Review, reflect, revise: updatig cotact lists, messages, ad materials Most sites will have doe a great deal of groudwork for dissemiatio plaig well before they prepare to close the study. Now is the time to revisit ad revise all of the materials, outreach evet formats, ad lists of stakeholders that you have developed ad compiled over the years. These resources should iform your dissemiatio pla. Decide which strategies have worked well i the past ad should be reused. Take a hard look as well at which previous commuicatios attempts did ot work ideally ad should be either improved or left out this time aroud. You should assess ad update your: Evirometal sca What did your eeds assessmet or sca of the research eviromet (see Chapter 2) tell you about the best ways to share iformatio with trial stakeholders? For some stakeholders, a message explaiig the results may be sufficiet. For others, it may be more appropriate to schedule a telephoe call or visit. Iteral ad exteral audieces (see Chapters 2 ad 7) Have ew players etered the field sice your study bega? Have ew doors become iterested? Are ew advocacy etworks followig your research? Key stakeholder lists, icludig media cotacts Over the course of a trial, may people chage positios. Plaig for dissemiatio provides a good opportuity to update cell phoe umbers, addresses, ad other cotact iformatio. Key ad supportig messages that covey ad cotextualize the study ad key fidigs (see Chapter 7) Evet reports or other materials used at public evets held throughout this or other studies at your site Was there a lot of iterest? A good tur-out? Did the evet provide people the best veue for uderstadig the trial results? Were there ay problems that you could have preveted? Backgroud materials (see Box 6.4) 93

9 ad outcomes (Natioal Ceter for the Dissemiatio of Disability Research 2001) III Timig, timelies, ad time zoes Timig is everythig, ad with thoughtful plaig, timelies ca be maaged just like aythig else. Yet whe you are preparig to dissemiate the study s results, it ca ofte feel like everythig is happeig at oce. There The oly reaso for time is so is a ogoig ebb ad flow whe rushig to prepare your draft that everythig does t happe pla to meet iteral deadlies ad the waitig for the aalysis of results before you ca fialize the strategy. You will eed to develop at oce. a detailed timelie, which will become your most valuable tool (ad, at times, most despised as frequet chages are required to be Albert Eistei made). Beyod site ad sposor demads, multiple stakeholders aroud the world ad i may time zoes will wat up-to-the-miute reports ad iformatio. Timig will ot dictate everythig, but it will determie a lot. Developig ad revisig your timelie will be a ogoig activity throughout the course of your dissemiatio plaig. (See Appedix 6.3 for a case study of timelies ad tasks ivolved i dissemiatig the results of a multiceter microbicide trial.) Here are some major poits to cosider whe developig your timelie. Now that you have determied how you wat to release your results, cosider what is feasible. Your timelie should work backwards from a tetative release date, allowig eough time for each dissemiatio activity you pla. Remember that your timelie will evolve ad chage util the last miute. Be flexible. FHI If your trial closes prematurely, your timelie for dissemiatio will be highly compressed. Research istitutios sometimes have to close a study early for a variety of reasos operatioal problems, safety cocers, or the iability to determie a product s effectiveess ( futility ). I some cases, the trial s idepedet data ad safety moitorig board (DSMB) or data safety committee may recommed early closure because the data show that the product is highly effective, makig it uethical to withhold the Dr. Elisabeth Madraa, Programme Maager at the Natioal AIDS/STD Cotrol Programme i Ugada, presets at the Africa Regioal Meetig o Hormoal Cotraceptio ad HIV: Sciece ad Policy i Nairobi, Keya, Participats siged cofidetiality statemets so that they could discuss study results prior to publicatio ad provide guidace o iterpretatio to the research team. 94 Commuicatios Hadbook for Cliical Trials

10 Box 6.4. Advice o updatig commuicatios products By Melissa May, Former Director of Public Iformatio, Populatio Coucil, New York Hadlig the release of the Carraguard microbicide trial results, we leared the hard way about versio cotrol : maagig a documet with multiple cotributors ad reviewers so that oe master icorporates everyoe s chages. The difficulties were compouded i that project because of the umber of differet commuicatios products that we were producig to support the release. Early o, we realized the beefits of givig every documet a ame that we could use to refer to it, ad the to always use that ame as the documet title, together with a umber for versio cotrol. By the ed we had the media backgrouder the iteral Q&A, the exteral Q&A, the South Africa coutry hadout, ad the advocates PowerPoit, amog may other documets. We also leared that it is much easier to have all updates to materials maaged by oe perso, who is resposible for updatig all versios, postig them to the Web, ad circulatig them. I the begiig, we had way too may cooks i the kitche! Ad fially, we realized the beefit of keepig track of where iformatio was repeated. I our materials spreadsheet, we oted which commuicatios products icluded key bits of iformatio so that we could easily update the materials e masse as ew iformatio became available. We eve created dummy pages o a passwordaccessible Web site, which could be completed easily oce the fial results were kow. Pla to post all team materials i a cetral locatio (a shared drive or other iteral, orgaizatioal Web portal, or a password-protected bulleti board). This is essetial for versio cotrol. TIP product from participats i the placebo arm of the trial. (See Chapter 5 for a more detailed discussio o maagig premature trial closures.) Allow eough time for coordiatio betwee the sposor or cetral etwork ad the sitelevel team. Appropriate members of the research team perhaps at multiple sites should have iput o the core documets. You will also eed to allow time for culturally specific adaptatios ad traslatios of the documets. Pla for staff attritio ad closure of study budgets. Staff members ofte leave toward the ed of a trial to take other positios, kowig that a give study will be closig. I additio, there may be a large time gap betwee the aoucemet of the results at a iteratioal scietific coferece ad the timig of a dissemiatio meetig for commuity members where the study was coducted. Cosider how the loss of staff members ad fiacial resources at trial s ed will affect your ability to carry out appropriate dissemiatio activities. Budget for adequate staffig to share results locally after the trial has eded. If your study team decides to release the results at a coferece or i a joural, you should fid out the schedule. For cofereces: Whe are abstracts due for the coferece(s) you have chose for presetatio of the trial s results? Does the coferece cosider late-breakers, ad if so, whe are those abstracts due? For jourals: How log ca you expect to wait for a decisio about mauscript acceptace? Will the joural agree to fast-track your submissio? Oce accepted, how log before it will 95 be published or available olie?

11 Box 6.5. Choosig a meetig for the presetatio of results By David A. Grimes, MD, Distiguished Scietist, Family Health Iteratioal, ad Professor, Departmet of Obstetrics ad Gyecology, Uiversity of North Carolia School of Medicie, Chapel Hill, NC Choose early Whe possible, both the iteded joural for submissio ad the iteded veue for presetatio of research fidigs should be agreed upo by the team before the study begis. As with the joural, the choice of meetig should reflect the iteded audiece. To whom is your message goig? Some meetigs draw public health professioals, others iclude cliicias, some a mix, ad some attract lay or professioal media as well. Be busiesslike i plaig Deadlies for submissio of abstracts ted to occur six to ie moths before a meetig. Do ot let these deadlies seak up o you. After you choose your iteded meetig, get the abstract submissio date o your caledar, with regular caledar warigs i advace of the deadlie. Poster or oral presetatio Meetig orgaizers are more liberal i acceptig abstracts as posters tha as oral presetatios. Because of limited hours for oral presetatios, most abstracts are accepted oly as posters. Weigh the pros ad cos. Posters are harder to produce tha PowerPoit presetatios, cost more, are hard to trasport, ad get less attetio. However, posters are still prestigious at some scietific cofereces, ad may offer the oly opportuity to share your fidigs. Be cautious about sharig your slides or mauscript A reporter may ask you for a copy of your full mauscript ( I was t able to take otes as fast as you preseted; would you mid givig me a copy of your paper so that I ca get the facts straight? ) Politely declie the request to share ay more detail tha what was i your public presetatio. Accordig to the Igelfiger rule (Relma 1981), publicatio of abstracts up to 400 words i legth does ot costitute prior publicatio. Should a reporter write a colum about your presetatio that carries more detail (such as tables) tha your oral presetatio, you may compromise your ability to publish your work. Whe dealig with reporters at meetigs, be careful about sharig upublished data. Helpig a iterested reporter may iadvertetly sabotage your publicatio. Prior publicatio Some meetigs refuse to cosider research that has bee published. If your mauscript is i press at a joural, you have little cotrol over whe it will be published. Advise the meetig orgaizers of this ad submit it ayway. Give the log publicatio queues at may jourals, your paper may ot appear i prit util well after the meetig. Collaborate with the meetig press The meetig orgaizers may hold press cofereces. Jouralists may ask for a iterview after your presetatios. These opportuities provide you a chace to share your results with the public via the press, but stay o message regardig your data. Stick to what you preseted. Network with colleagues Sped time i the lobby, at social fuctios, ad i the exhibit hall. Ofte more is leared i these settigs tha i the formal sessios. Carry a stack of busiess cards with you. Sed ew cotacts a friedly upo your retur to home, sayig that you ejoyed meetig them. Networkig is importat, ad those who express iterest i your research may appreciate gettig a copy of the published article whe available. 96 Commuicatios Hadbook for Cliical Trials

12 FHI Dr. David Jekis of FHI explais study data at a poster sessio at the 2008 Microbicides Meetig i Idia, while Dr. Naresh C. Jai, Assistat Editor of the Idia Joural of Medical Research, listes. Seek to disclose the results to participats as close to the public aoucemet of fidigs as possible. A ew ethic is evolvig to esure that participats lear of results close to the time they are made public. Give the cotributio that participats make to the overall research process, it is respectful to esure participats lear results directly from the research site rather tha hear a iterpretatio of the results through the media. Iformig participats ad local officials first also helps to balace the iformatio eeds of local collaborators ad iteratioal audieces, ad couters the perceptio that research is exploitative ad cotrolled by outsiders. Some of the factors related to timig ivolve maagig cofidetiality requiremets. You should decide whe to commuicate with which tier of stakeholders (e.g., study team, govermet officials, other iterested parties). Do whatever is possible to esure ay embargoes are hoored, for example, by askig that recipiets sig cofidetiality statemets that will be i effect util the results are made public. However, you should also pla for the possibility that the results could be leaked before your scheduled release date. Take time zoes ito accout whe plaig. As your team develops its aoucemet ad dissemiatio strategy, cosider your priority target groups ad their geographical locatios, the umber of locatios where your aoucemets may take place, ad ay logistical limitatios that time zoes might impose. For example, if your study takes place at sites i Lati America, the Uited States, ad souther Africa, you will eed to idetify a time for public release that works for all time zoes. Do ot forget to factor i British Summer Time (BST) for UK audieces ad Daylight Savigs Time (DST) for groups i the Uited States. 97

13 Box 6.6. Timig the aoucemet of results: the AIDS vaccie study i Thailad By Lisa Reilly, Commuicatios Director, U.S. Military HIV Research Program (MHRP), Hery M. Jackso Foudatio for the Advacemet of Military Medicie, Rockville, MD I the fall of 2009, I coordiated the public aoucemet of the results of the Thai vaccie study the largest-ever HIV vaccie trial, led by researchers from the U.S. Military HIV Research Program ad coducted by the Thai Miistry of Public Health (MOPH). We developed a phased aoucemet strategy to accommodate the three time zoes our collaborators were i, which spaed 11 hours. A coordiated ad cetralized approach to media relatios ad stakeholder egagemet played a critical role i reachig target audieces ad mitigatig potetial issues. This strategy was agreed to moths prior to learig the results. Our iitial aoucemet was made i Thailad o September 24th, 2009, a importat Thai holiday ad the aiversary of the trial s start date. Thai researchers requested this date ad all of the collaborators agreed that the participats should be iformed first. The followig day, we held a telecoferece with a pael of scietists who discussed the results with members of the media. The study team also submitted a Draft for iteral use oly Summary of Iteratioal Evets to Aouce the Thai Phase III (RV144) Results: THAILAND USA FRANCE Date Time Activity Date Time Activity Date Time Activity 22:00 11:00 KOL CONFERENCE CALL 17:00 KOL CONFERENCE CALL 23:00 12:00 18:00 24:00 13:00 19:00 01:00 14:00 20:00 02:00 15:00 21:00 03:00 16:00 22:00 04:00 17:00 23:00 05:00 18:00 24:00 06:00 19:00 01:00 07:00 20:00 02:00 08:00 21:00 03:00 09:00 22:00 04:00 10:00 23:00 05:00 11:00 24:00 06:00 12:00 01:00 07:00 ISSUES PRESS RELEASE 13:00 PRESS CONFERENCE 02:00 LIVE LINE TO THAI 08:00 PRESS RELEASE ISSUED MEDIA EVENT 14:00 VOLUNTEER CONFERENCE CALL 03:00 09:00 15:00 MOH STAFF HOLD FOR MEDIA 04:00 10:00 CONFERENCE CALL INTERVIEWS FRENCH PRESS MEDIA 16:00 THAI ADVOCACY 05:00 11:00 MANAGEMENT 17:00 CONFERENCE CALL 06:00 12:00 18:00 07:00 13:00 19:00 08:00 14:00 20:00 LIVE LINE TO U.S. INTERNATIONAL SANOFI LED EVENT TO 09:00 15:00 MEDIA EVENT MEDIA CONF CALL MEDIA CONF CALL ADVOCACY ADVOCACY 21:00 HOLD FOR MEDIA 10:00 16:00 CONFERENCE CALL CONFERENCE CALL INTERVIEWS 22:00 11:00 MEDIA INTERVIEWS 17:00 FRENCH KOL/MEDIA 23:00 12:00 18:00 INTERVIEWS 24:00 13:00 19:00 01:00 14:00 20:00 02:00 15: MHRP 21:00 03:00 16:00 EMPLOYEE BRIEFING 22:00 04:00 17:00 23:00 THURSDAY 24 FRIDAY WEDNESDAY 23 THURSDAY 24 WEDNESDAY 23 THURSDAY 24 paper to the New Eglad Joural of Medicie (NEJM), ad plaed to preset the results at the AIDS Vaccie Coferece i October, several weeks after the aoucemet. Before the publicatio ad presetatio i October, we briefed several groups of HIV researchers about detailed trial data uder cofidetiality agreemets. Some aalyses were leaked to the press, ad because we were uder embargo, we could ot address the questios raised before our article was published i the NEJM. I hidsight, the iitial aoucemet to the voluteers should have bee plaed closer to the presetatio ad publicatio date to avoid this gap i public discussio of the full data. : 98 Commuicatios Hadbook for Cliical Trials

14 Fially, try to aticipate other factors that might affect your aoucemet strategy. For example: Does weather affect plaig for evets durig a particular time of year? Will holidays or other sigificat dates iterfere with the release of your results? Is it importat to your istitutio to iform trial participats i a formal meetig before presetig your fidigs to the scietific commuity i your coutry or iteratioally? Will labor patters (such as seasoal work) affect your ability to reach participats? Will some govermet officials eed to be iformed before others? What are the possible repercussios of the dissemiatio of the trial s results? Box 6.7. Commuicatios timelie ad milestoes for dissemiatio of trial results Revisit your iitial commuicatios strategy with dissemiatio i mid. Idetify ew eeds ad opportuities. Cosider your goal, audiece, medium, ad executio. Establish a dissemiatio plaig team ad a decisio-makig policy. I additio to your existig commuicatios team, you may wat to ivolve additioal stakeholders, such as CAB members. With your team, discuss ad decide which members will have decisio-makig authority. As a team, discuss your dissemiatio goals ad develop a writte dissemiatio pla. Weigh the pros ad cos of differet release strategies. Establish your goals ad priority audieces. Pla differet activities for each priority audiece. Update lists, materials, ad messages as ecessary. Look over cotact lists; esure they are curret ad accurate. Accout for ay chages that have occurred sice the start of your trial that may affect your dissemiatio strategy. Determie the timig of the aoucemet. Choose a tetative release date. Decide whe to release the results to various stakeholders: staff, participats, sposors, etc. Idetify evets or other factors that may affect your aoucemet strategy. Pla for various outcome scearios. Discuss ad develop key messages for those scearios (positive, eutral, ad egative). Share each sceario; meet with site teams ad other stakeholders to discuss implicatios of each sceario. Cosider the ways each sceario might affect your aoucemet strategy. Determie top lie (key) ad supportive messages for each outcome; traslate materials as ecessary. 99

15 Maage pre-release issues. Put systems i place for whe the results are kow. Cosider the eeds of both global ad i-coutry stakeholders. Determie the timig of the results for each group of stakeholders. Cosider coferece or publicatio embargoes. Pla the timig of media embargoes ad press releases. Orchestrate the public aoucemet. Implemet your aoucemet strategy. Cosider holdig a local aoucemet evet. Use differet approaches for differet stakeholders. Moitor ews media ad correct iaccuracies. Maage post-aoucemet dissemiatio activities. Cotiue to moitor media ad commuity cocers; respod whe appropriate. If you so choose, submit a mauscript to a scietific joural. Pla appropriate meetigs to ivolve stakeholders i determiig the implicatios ad applicatios of the results. Promote the applicatio of the fidigs; ivolve stakeholders i plaig, implemetig, ad evaluatig the applicatio of the results. IV Plaig for various outcome scearios You ca do a great deal of plaig ad site-level preparatio eve before you kow the aswers to your research questios. Sceario plaig is a ivestmet of time. It requires a willigess to commit to a process that by its very ature ivolves developig some strategies ad materials that will ever be implemeted or used. Yet, such preparatio is well worth it. Pictured here are local commuity leaders i Bamako, Mali. Whe plaig dissemiatio, cosider which commuity groups will wat to lear about trial results. Elizabeth T. Robiso/FHI Preparig for a umber of possible outcomes reduces the risk that you will be surprised. With good preparatio, the members of your commuicatios ad maagemet team will have discussed ad determied key messages for every sceario. This ehaces the likelihood that all team members ad parters will have accurate iformatio ad will be able to share cosistet messages about your results. Some teams eve test the messages with groups of participats to assess the effectiveess of the messages. 100 Commuicatios Hadbook for Cliical Trials

16 Box 6.8. Sceario plaig: a ivestmet i capacity buildig By Ae Coletti, MS, Scietist, Family Health Iteratioal (formerly with the HIV Prevetio Trials Network) I late 2008, the HIV prevetio field was preparig for the dissemiatio of results from the HPTN 035 microbicide study. Although a few ivestigators who were resposible for data aalysis kew the study results i early December about two moths before the public aoucemet scheduled for the Coferece o Retroviruses ad Opportuistic Ifectios i early February 2009 most of the site-level study teams ad all exteral stakeholders did ot yet kow the results. As the sites ad etwork staff worked o dissemiatio plaig ad puttig together materials for the possible scearios (positive, eutral, or egative trial results), the few of us who kew the results had to maitai strict cofidetiality. This meat helpig the site-level teams articulate the implicatios of various scearios, despite kowig which sceario i fact described the real results. At times, it was heartbreakig to sed scearios to the sites, kowig we were sedig them extra work. While those i the kow felt these scearios were paiful ad a waste of time o occasio, others outside the iformatio loop stressed the importace of sceario plaig ad the role of the exercise as a meas to build capacity at the sites ad to prepare the broader field. If I could do it over, I would wat to share the sceario-plaig materials moths earlier, ad work out the messagig before ayoe kew the results. This would have removed the time pressures from the sites to review ad traslate multiple materials, ad it would have give them more opportuities to thik through each sceario as a team. Take a methodical approach to plaig the outcome scearios. May people have casual coversatios at their site or i coferece hallways, askig questios such as, What will you do if the study results are positive? If the results show a effect, will all other studies testig this product be stopped? Is there a chace the fidigs could show harm? Although these hypothetical discussios ca be stimulatig, it is critical to employ strict parameters whe your team is doig sceario plaig i preparatio for the dissemiatio of your results. Cosider the followig issues as you pla for various outcomes of your trial: Your plaig should use the available data ad cotextualize the situatio to address ad aticipate possible scearios: positive results (the product or itervetio is prove effective), eutral results (the product or itervetio is prove ieffective), or egative results (the product or itervetio is show to cause harm). You should also describe the implicatios for each sceario. Other cosideratios i your scearios may iclude whether your study will be the first to release results o this itervetio or whether it may cofirm or dispute data from previous studies. If your study was desiged to test a product for regulatory approval, you may eed to cosider scearios about the effect of the data o licesure. Cosider how your aoucemet strategy varies with each sceario. For example, you may wat to actively seek major media coverage if the results are positive, but ot for flat results. Keep i mid that exteral stakeholders will take a greater iterest i your results if they are groudbreakig or uexpected whether the results are good or bad ews. 101

17 Cosider this i your plaig ad address how the strategy may eed to be adapted if your fidigs were to draw widespread iterest. Develop key ad supportig messages that explai all of the possible scearios so your audieces will uderstad the possible outcomes before the fial dissemiatio of your results (see Chapter 7). A easy way to develop your messages is to start by creatig a questios-ad-aswers (Q&A) documet. Here s how: 1. Make a list of the most obvious questios (as well as the hardest) that policymakers, other researchers, ews media, or commuity members may ask you for all of the possible trial outcomes. 2. Develop aswers to these questios i the form of a iteral Q&A sheet (see Appedix 6.4). For example: l l l l l Is the experimetal treatmet more effective tha curret treatmet? Is drug resistace a cocer? Was drug resistace moitored i the trial? How readily available is this product i resource-poor settigs? Do we kow if the ew treatmet is safe for pregat wome? Will trial participats cotiue to have access to the ew drug after the trial is over? Circulate the iteral Q&A amog the commuicatios team, ad revise it as eeded to make the aswers accurate, clear, ad succict. 3. Oce you have this documet revised, review it ad highlight the key ad supportig messages about the study ad the possible outcome scearios. These should stad out. Develop template materials for each of the mai scearios. Oce you have your key messages ad a iteral Q&A, you ca use these documets to develop other backgroud materials that will help you cotextualize your results. To maage the expectatios of others, you must explai your results i ways that are appropriate for each of your audieces. Prepare ad update dissemiatio materials. Oce you have determied your dissemiatio strategies, icludig how ad whe you wat to aouce the results to your various audieces, you should update all of your materials ad develop ay ew materials you will eed. To stay orgaized, develop a spreadsheet with iterim ad fial due dates, ad assig resposibilities. Pay attetio to versio cotrol so that you do ot iadvertetly share the wrog documets. Make sure that everyoe who receives the documets is aware that they are cofidetial drafts. A watermark, such as draft or cofidetial, ca make this clear. Most materials will eed to be developed as templates, based o your scearios, with placeholders for whe the results ad the data become available. Keep i mid that these should be traslated ad back-traslated for accuracy; also, some materials may eed to be approved by the Istitutioal Review Board (IRB). (See Appedix 6.5 for a sample letter to a ethics committee requestig review of materials eeded for the dissemiatio of results.) You may wish to develop some of the followig materials (Ceter for Iterdiscipliary Research o AIDS: Commuity Research Core 2009). (See Chapter 3 for more o materials developmet.) 102 Commuicatios Hadbook for Cliical Trials

18 Backgrouder o the results. Cocisely summarizes the study ad the mai fidigs of your research. The documet should be orgaized by topic areas, ad it should iclude key poits i bullet form. Fact sheets for specific audieces. These oe-page fact sheets iclude the mai fidigs i a short, bulleted format. These key poits ca be adapted for differet audieces. A fact sheet for scietific colleagues might iclude techical data ad umbers, whereas a fact sheet for the ews media should focus o the broader cotext ad public health sigificace of the fidigs. Press release. This ca be oe of the most efficiet ad effective ways to aouce your research results. Depedig o what media you target, press releases ca help you reach a wide variety of people i differet regios. These should be traslated for local-laguage media. Exteral Q&A sheet. Ulike the iteral Q&As described earlier, these Q&As are shared with the public (iterested parties) ad cover basic questios about why the study was coducted, what the study foud, ad what the implicatios are for the participats, for health care programs, ad for public health policy. Flyers, posters, ad brochures. Brochures ca offer a visually appealig way to release results to a broad audiece. Due to their limited space, their use will require cosiderable simplificatio of results. This may be appropriate for some studies ad highly effective for some audieces. (See Appedices 7.1 ad 7.2.) Letter of thaks to study participats. I additio to meetig with trial participats, you may also wat to write a letter to your participats, thakig them for their participatio ad explaiig research fidigs. Newsletters about the trial. If you have a regular ewsletter, this ca be a very effective way to reach certai stakeholders, such as doors ad other scietists (see Appedix 3.4). 02 December 2009 To: Commuity Members/Stakeholders/Gatekeepers RE: FINAL RESULTS UPDATE ON MDP 301 RESEARCH STUDY The HIV Prevetio Research Uit (HPRU) of the Medical Research Coucil (MRC) i Durba has bee coductig the MDP 301 cliical trial at the MRC research sites based i Togaat, Verulam ad Isipigo sice December To date, we have bee workig i partership with commuity members ad provided regular feedback o the research progress ad held several commuity based traiigs, outreach ad educatio sessios. This cliical trial has bee recetly completed ad fial results are expected to be available to the public o 14 December As a importat stakeholder, we would like to share the fial results before they become available to the public. We therefore humbly request your presece at this meetig where we will provide the commuity with the fial results of the MDP 301 Trial. The trial would ot have bee successfully completed without the support, assistace ad collaboratio of commuity members ad all stakeholders ivolved. Your participatio ad iput at this meetig will be most appreciated. The meetig details are as follows: DATE: VENUE: TIME: 10:30-12:30 Yours Sicerely Yuki Sookrajh MDP Maager Cc Prof Gita Ramjee RSVP: 14 December 2009, Moday MRC Isipigo Site, 3-13 Police Statio Road, Isipigo Mduduzi Ngubae Tel: Fax:

19 V Maagig embargoes ad pre-release issues After moths of plaig ad sleepless ights, the day will come whe the study results become kow to select members of the study team. This is a critical time for studies ad site teams, as iformatio disparities, sesitivities aroud cofidetiality, ad the potetial for leaks become daily realities for your site. Make a effort to discuss ad determie how the team will hadle this period before the results are disclosed to ayoe at the site. This will lesse the tesio for everyoe ad help to maitai a sese of solidarity withi your team. I the weeks leadig up to the public aoucemet, you ca expect time to move fast, timelies to chage ad to-do lists to expad i other words, expect the uexpected. A tiered distributio system, liked to a timelie, will help you keep track of what groups you eed to otify, ad i what order. Cosider the followig steps to maage this period: Step 1. Put systems i place to prepare for the results. Ofte oe or two ivestigators at each site lear the results as soo as they become kow ad are swor to strict cofidetiality. Meawhile, the rest of the study staff must wait util just before the public aoucemet. This is the cruch time whe dissemiatio plas ad materials eed to be fialized. Determie how your site will maage the workload ad cosider usig cofidetiality agreemets with certai staff members who may eed to lear the results to do their jobs. Your site should decide: Who will coduct supplemetary aalysis after ublidig? Who will see the documets but ot be directly ivolved? Who will fialize all the materials? Who will traslate them ito local laguages if ecessary? Who will arrage pre-embargo briefigs with govermet officials ad other key stakeholders, ad which staff members will atted? Step 2. Balace the eeds of i-coutry stakeholders ad global stakeholders. Whether your study operates at a sigle site ad works with oe istitutio, or is a multisite, etworkdrive study, you will have to address the eeds of both i-coutry ad global stakeholders. These may iclude doors, the trial sposor, scietific colleagues, policymakers, ad global advocates. Step 3. Decide who eeds to kow what, whe, ad how. By ow, you should have updated the list of your stakeholders ad selected the ews media you pla to iform. If you have ot doe so already, it is time to group these people ito categories or tiered lists for your iteral use. Separate out idividuals who should be otified before the official results are released publicly ad those who ca wait for the official aoucemet. 104 Commuicatios Hadbook for Cliical Trials

20 Group the people i your eed to kow early list by professio to help you pla ay preembargo briefigs ad materials. These lists will ofte mirror your audieces that you idetified earlier i the study. Although you wat to keep a relatively short list of people you eed to iform early, remember to thik outside of the usual suspects. For example, if you are releasig results for a tuberculosis vaccie study i childre, remember to iclude leadig pediatricias o your stakeholder list. Eve if the pediatricias do ot work o tuberculosis, jouralists are likely to call these opiio leaders. Step 4. Accout for coferece ad publicatio embargoes. Every publicatio ad almost every coferece has a embargo policy cocerig the timig of public releases. It is importat to uderstad exactly what you may ad may ot do withi the cofies of the embargo. Eve if you have released fidigs at a particular coferece before, check agai, as policies may chage from year to year. If you are releasig your results at a coferece, fid out how media relatios are coordiated. Most scietific cofereces hold press briefigs for attedig jouralists, ofte selectig the most itriguig abstracts that they thik may be ewsworthy ad the schedulig press cofereces aroud those topics. You may also be able to request a press briefig. I this case, be prepared to sell your topic, explaiig why it is ewsworthy ad who will preset it. If your abstract gets selected for a press coferece at a scietific meetig, this may affect your embargo time as well as your aoucemet strategy. If you are publishig the results i a joural, fid out the embargo date ad whe the article is likely to be posted olie. Also, fid out if you ca pre-release ay iformatio uder embargo ad uder what circumstaces. Step 5. Carefully pla media embargoes ad the timig of your press releases. There may be restrictios o media coverage if you are also submittig a mauscript to a joural or releasig your results at a coferece or evet. Embargoes are usually respected by professioal health jouralists. This meas that studies may choose to share their press release shortly before the public aoucemet with certai jouralists, uder the agreemet that the jouralists may ot publish their story util the embargo has lifted. This strategy allows jouralists the time to write accurate ad well-researched articles, iterview stakeholders, ad get quotes so that their stories are ready to be prited the momet the embargo lifts. If you are plaig to share a press release with selected jouralists before your embargo lifts, remember these tips: Whe plaig for dissemiatio of results, remember to iform relevat govermet officials ad doors. I this photo, Carl Hawkis from USAID Nigeria speaks with Dr. Christoph Hammelma, Director of FHI/Nigeria. Imad Ulayi/FHI Nigeria Check with the joural or meetig to determie if you are permitted to share a press release or the abstract uder embargo with reporters. Always iclude the time zoe whe the embargo lifts o your press release. For example, 105

21 if you are releasig results at a coferece i Russia, do ot write, Embargo lifts at 13:00. Write Embargo lifts at 13:00 Moscow / 10:00 UK / 03:00 EST. Iclude the mai time zoes where you are sedig the release to jouralists. Provide this iformatio at the very top of the press release so that it ca ot be missed. List at least two cotact umbers, icludig at least oe local mobile umber. Offer recommedatios ad cotact iformatio of experts who have bee iformed of the results o a cofidetial basis prior to public release ad who could be available for iterviews ad to give quotes. Check the local culture aroud embargoes ad let that iform your strategy. For example, whe commuicatios officers arrived i New Delhi, Idia, for the Microbicides 2008 Coferece, they were surprised to fid out that most local jouralists did ot respect embargoes. It simply was ot i their jouralistic culture. This iformatio swayed some people to hold oto their press releases util the official embargo eded. Box 6.9. What is the U.S. Securities ad Exchage Commissio ad how could it affect the timig of the release of trial results? The U.S. Securities ad Exchage Commissio (SEC) was created durig the Great Depressio i 1934 primarily to protect ivestors. The agecy works to eforce laws that require publicly traded compaies listed o the New York Stock Exchage to tell the public the truth about their busiesses, icludig products they are developig ad the risks ivolved i ivestig i them.* Whe a research trial is testig a experimetal product that is owed by a publicly traded (commercial) compay, the compay has legal obligatios to publicly iform its stockholders of ay major fidigs about the product, whether good or bad ews. The SEC rules state that compaies must iform the public withi 24 to 48 hours of the trial fidigs becomig kow, to prevet isider tradig of stocks or securities. However, i cases of sudde closures or uexpected fidigs, some trial sposors have bee able to egotiate directly with the SEC to delay the public aoucemet of study results, ad thereby gai time to otify Miistry of Health officials or other trial stakeholders directly before they hear about it o the ews. (See Chapter 5 for more iformatio.) For this reaso, some trials ow strategically time their DSMB meetigs to take place o Fridays. This way, if ay major chage or trial closure is recommeded, the trial team will have the etire weeked to otify stakeholders ad implemet a emergecy dissemiatio pla o Moday morig. This works because the SEC time requiremet that the public be iformed withi 24 to 48 hours excludes Saturdays ad Sudays, sice the New York Stock Exchage is closed ad o tradig of stocks ca occur over a weeked. *Source: Commuicatios Hadbook for Cliical Trials

22 VI Orchestratig the public aoucemet Your public aoucemet requires careful orchestratio ad choreography. It is the day that the curtai goes up ad the world comes to kow your trial s results. Cosider the followig activities as you coduct your pla. 1. You may wat to work with a i-coutry commuicatios firm to implemet your aoucemet strategy. You could cosider a iteratioal or atioal commuicatios firm with offices ad cotacts i the coutries hostig trial sites. Such firms ca provide vital liks to i-coutry media ad logistical assistace to arrage meetigs ad other activities. Be aware of the eed to foster close coordiatio betwee the firm ad local site leaders, especially if the firm is reachig out to opiio leaders of strategic ad political importace to local ivestigators. Eve if you caot hire a public relatios (PR) firm, cosider whom to ivolve to esure that stakeholders have appropriate access to trial results ad to ehace the use of the fidigs by health systems. 2. Cosider hostig a local aoucemet evet. May sites host local evets for their trial participats ad the local commuity. This is a opportuity to share the study results ad thak all of your stakeholders for their support durig the study. You may decide to ivite media to this evet, or you may choose to hold a media briefig separately, perhaps just before the public evet. I this case, jouralists would be able to receive a briefig o the results targeted for them ad ask ay questios, but the could stay to participate i the larger evet for cotext. Whe plaig your local evet, make sure the timig fits i with the study s larger timelie ad ay embargo limitatios. 3. Use your aoucemet evet to salute your participats, staff, ad parters. Regardless of your results, your aoucemet evet is a time to celebrate the completio of a cliical trial. Use your evet to ackowledge publicly the participats, staff members, ad local leaders who provided support durig the study. Cosider askig a local leader to take part i the program ad a trial participat to speak at the evet (see Box 6.10). If you are plaig or preparig for future studies at your site, let the audiece kow that you are stayig i the commuity ad you would appreciate their ogoig support with future studies. YouthNet/FHI The Iteratioal AIDS Coferece is a importat veue for dissemiatio of HIV prevetio research. 107

23 Box Givig voice to trial participats By Prof. Gita Ramjee, HIV Prevetio Research Uit, Medical Research Coucil, Durba, South Africa ad Dr. Nyaradzo Mgodi, Uiversity of Zimbabwe-Uiversity of Califoria at Sa Fracisco Collaborative Research Program TIP Idividual istitutioal review boards (IRBs) or ethics committees ca sometimes determie the extet to which the research staff may facilitate a iteractio betwee curretly erolled trial participats ad the ews media. I geeral, however, IRBs do ot allow researchers to proactively promote cotact betwee erolled participats ad ews media. Eve if a idividual participat is willig to speak with a jouralist, other erolled participats may ifer that the research team has broke the promise of cofidetiality ad might do the same to them. Gettig IRB approval for participats ivolvemet with the media Speak to your IRB early. Liste to ay cocers, such as protectig cofidetiality, ad fid creative ways to address them appropriately i your settig. Work with your IRB to develop a best-practices policy for allowig trial participats to egage with the media. For example, develop a protocol for selectig potetial trial participat spokespersos, icludig esurig that voluteers are adequately prepared for the experiece of beig iterviewed. Submit the protocol for review. Share with your IRB examples of past successful experieces. Brig media clips that iclude quotes from trial participats of other studies. Explai the dowside if the site does ot proactively ivolve trial participats i media iterviews. Media may ed up talkig to ill-iformed or disgrutled participats. Oce a trial is over, however, ethics committees typically o loger gover the research team s role i such commuicatio. Durig the dissemiatio of results of the HPTN 035 microbicide trial i souther Africa, differet sites coductig the same study had differet views ad experieces with likig former trial participats with ews media coverig the dissemiatio of results. I Durba, South Africa, the research team ivited a few former trial participats to the local media briefig aoucig the results. These wome were o loger active trial participats. After the briefig, the former participats did oe-o-oe media iterviews with jouralists upo request. The wome had agreed to speak with the media before kowig the study results or eve which trial arm they were i. They shared their first-had experiece of the research process with jouralists ad gave iterviews i Eglish ad Zulu, the local laguage. Resultig local laguage ad atioal press coverage icluded profiles of trial voluteers ad quotes that highlighted the huma story behid the research statistics. I Harare, Zimbabwe, HPTN 035 participats did ot take part i media iterviews whe results were dissemiated. The study staff had earlier idetified some wome who could be iterviewed by media persoel if the eed arose, but ever obtaied local IRB permissio to do so. Oce results were ready for dissemiatio, some participats were still beig followed for various outcomes (such as pregacy). Ultimately, give the time limitatios, ad because participat iterviews were ot icluded i the master pla for dissemiatio of results, study staff did ot pursue approval for such iterviews from the study s IRB. 108 Commuicatios Hadbook for Cliical Trials

24 MDP participats from Africa Cetre i Mtubatuba, South Africa, prepare sogs ad dace (with male ad female codoms i had) to celebrate the successful completio of the MDP 301 trial. Mitzy Gafos/Africa Cetre Box Orgaizig differet meetigs for differet groups of local stakeholders By Dr. Ikoma Obuge, Uiversity of Port Harcourt Teachig Hospital, Nigeria I Port Harcourt, we orgaized a series of dissemiatio activities to share the results of the cellulose sulfate Phase III microbicide study i Nigeria. This trial had flat results, yieldig o evidece that the product helped to prevet HIV or that wome usig the product were at greater risk of HIV acquisitio. We decided to orgaize separate activities for three differet categories of stakeholders: Study participats. Two outreach workers coordiated with the pricipal ivestigator or the site coordiator to cotact more tha 600 former participats by telephoe. Text messages were set as a remider to all participats who accepted the ivitatio. O the morig of the dissemiatio meetig, a wake-up call was made as a remider. Two sessios were held to accommodate the 120 former participats who atteded. These sessios icluded a overview of the study ad a summary of the results, the plety of time for discussio. Miistry officials, govermetal agecies, regulatory authorities, ad civil society orgaizatios. The site team orgaized a meetig with officials of the Rivers State Actio o AIDS Committee to develop a list of relevat stakeholders. The Miistry of Health, Natioal Agecy for Drug ad Cotrol, Plaed Parethood Federatio of Nigeria, ad various civil society groups (people livig with AIDS, faith-based orgaizatios, youth, ad AIDS prevetio groups) were ivited by letter. The pricipal ivestigator preseted the study results to the 47 people who atteded, the addressed commets ad questios from attedees. The Uiversity of Port Harcourt Teachig Hospital commuity. We otified hospital maagemet ad heads of departmets of various uits of a presetatio of the results. Three co-ivestigators preseted the results to 52 attedees, the aswered questios from hospital colleagues. 109

25 Box Dissemiatig iformatio, demadig iformatio: the dual roles of advocates whe trials close By Deborah Baro, MMCI Coordiator, GCM ad Lori Heise, Former Director, Global Campaig for Microbicides* The closure of the N-9 study i 2000 ad protests about the oral teofovir PrEP trial i Cameroo i 2005 taught the HIV prevetio research field critical lessos i commuicatios wherever iformatio gaps exist, misiformatio ad rumor will fill the void. Less tha a decade later, whe the cellulose sulfate (CS) trial closed early, o fewer tha 27 advocacy ad citize media list servers covered the closures (Robiso 2007). These list servers eabled groups to maitai a steady iformatio flow ad dispel ay surfacig rumors about the CS study ad closure. I the lead-up to the public aoucemet, a few log-time advocates were iformed of the closure durig the pre-embargo period. Early access to cofidetial iformatio eabled these groups to pla ahead ad strategize a public respose. The U.S.-based groups Global Campaig for Microbicides (GCM) ad AVAC, as well as the Africa Microbicide Advocacy Group (AMAG), decided to release a joit statemet timed with the public aoucemet of the closure. The key message stressed the importace of cotiuig microbicides ad other biomedical prevetio research (Africa Microbicides Advocacy Group ad others 2007). I additio to the press statemet, these groups circulated backgroud materials ad a iitial Q&A to their list servers, reachig over 5,000 advocates worldwide. The quick availability of easy-to-uderstad materials helped quell cofusio ad suspicio amog advocates. The AMAG list server ad Nigeria AIDS e-forum moderated by Jouralists Agaist AIDS offered olie platforms for Africa advocates to express cocers ad ask questios about the scietific ad ethical procedures of the closure. Trial sposors ad site staff members were ivited ad ofte respoded to questios i these e-forum dialogues (Robiso 2007). Sice may people i Africa lack reliable Iteret access, the GCM sposored a series of tele-briefigs that gave stakeholders a opportuity to ask questios directly of the ivestigators ad members of the idepedet data ad moitorig committee that made the recommedatio to stop the trial. By providig direct access to key decisio makers, these calls helped to dispel rumors, reduce suspicio, ad dissemiate accurate iformatio. *Lori Heise is curretly a Lecturer at the Geder, Violece ad Health Cetre, Lodo School of Hygiee ad Tropical Medicie. 4. Eve at the commuity level, you may eed to group stakeholders i differet categories ad iform them of the results through differet approaches. Here are some basic tips o iformig stakeholders: Govermet stakeholders ad policymakers. Do ot uderestimate the political importace of esurig that key govermet stakeholders hear the results directly from you, rather tha from others (especially the ews media). With officials, face-to-face cotact is especially importat. Appoitmets for meetigs should be made with drug regulatory authorities, ethics review committees, ad appropriate Miistry of Health staff, with plety of lead time. 110 Commuicatios Hadbook for Cliical Trials

26 If you pla to distribute writte materials, keep i mid that busy officials may ot have time to read log reports. Iclude a executive summary explaiig what you studied, why you studied it, ad what major fidigs ad coclusios your research geerated (Uli ad others 2005). Participats. There are a variety of dissemiatio activities that ca help you iform your trial participats of the study s results. I additio to hostig a commuity forum or a meetig of participats speakig at popular forums or local churches you ca sed a ewsletter or a letter of thaks to participats, explaiig the fidigs of the study. Cosider sedig SMS (short message service) text messages to participats iformig them where they ca pick up ewsletters. As members of research commuities, advocates ofte kow the best ways to reach their commuities, deal with egative media situatios, ad help research groups develop effective commuicatios strategies. The local commuity. I additio to sharig results with trial participats, iformig commuity members ear the sites is a recommedatio ow icluded i iteratioal guidace documets (Heise ad others 1998; UNAIDS Microbicide Trials Network ad the Populatio Coucil ). You may wat to have a ope meetig to explai your results ad allow members of the commuity to ask questios about the study. Creative ideas such as plays ad sogs ca be very effective i deliverig your messages to the commuity i a way that is uderstadable to people with little kowledge of sciece. (See Appedix 6.6 for a sample letter ivitig commuity stakeholders to lear study results.) Advocacy etworks. It is also importat to iform other trial etworks, as well as both atioal ad trasatioal advocate etworks. May of these groups ca be reached through list servers ad targeted press releases. You may also wat to cosider co-hostig with a advocacy group a toll-free dial-i coferece call i order to reach these etworks. 5. Determie how to cotact health jouralists who will ot atted your aoucemet evet. Whe you are aoucig study results at a coferece, for example, you may also wat to telephoe or selected reporters who are ot able to atted. A simple grid listig the idividual reporters you pla to reach ca be a useful tool whe you are preoccupied with the details of maagig the aoucemet of your results. 6. Diligetly moitor the media so that you ca quickly correct their mistakes. If possible, assig a staff member to moitor media durig the week of the release. If media coverage spas a few laguages i your commuity, cosider assigig oe perso to cover each laguage s media. This perso should read all articles ad have eough kowledge of the study s results to be able to check articles for iaccuracies (see Chapter 9). 7. Take care of yourself ad your staff prevet staff bur-out. No matter how much you pla, the weeks leadig to ad the week of the release will etail may log hours ad late 111

27 ights. Make sure you set aside some persoal time before the pace picks up ad advocate for staff to take a day off i the ru-up to the fial stretch. This will help everyoe to recover their eergies ad go the extra mile durig the week of the aoucemet. VII Post-aoucemet dissemiatio activities Dissemiatio activities do ot ed after the results are aouced to the public. Depedig o a variety of factors (the outcome of the study, the size of the trial, the timig of the release), media coverage ad iquiries may cotiue for weeks, ad eve moths, after the results are public. Cotiue to moitor the cotet of the coverage, ad the spread of ews o list servers, blogs, ad similar outlets. Oce your study results are covered i the media, you should maitai a archive of articles. This may be helpful for future research. Commuity members, govermet officials, ad other iterested parties may cotiue to have questios about the study s results after the trial closes. Make sure you pla for this, ad have eough staff o had to aswer questios ad maitai relatioships with your cotacts. Cosider the followig steps: Step 1. Submit your mauscript to a scietific joural for peer review ad publicatio. Publicatio i a peer-reviewed joural is oe of the most importat steps i the dissemiatio of your study s results to the global scietific commuity. The peer-review process is i place to prevet the dissemiatio of irrelevat fidigs, uwarrated claims, uacceptable iterpretatios, ad persoal views. It is the resposibility of the etire team to esure that study results are published i a joural that offers other researchers ad public health professioals access to the fidigs. Box Dissemiatio factors that promote the use of research results The iformatio eeds of specific audieces are cosidered whe desigig the study. A wide rage of stakeholders are egaged throughout the trial (Rogers ad Storey 1987; Havelock 1969; Cerada 1982). The credibility ad reliability of the research fidigs are accepted by users of the study. Fidigs are dissemiated to multiple audieces usig a variety of chaels ad formats. Presetatio of fidigs emphasizes the importat lessos leared, especially from the poit of view of the iteded audiece, rather tha the eed for more research. Source: PR Uli, ET Robiso, EE Tolley. Qualitative methods i public health: a field guide for applied research. Sa Fracisco: Jossey-Bass; p Reprited with permissio. Adapted from Sharma Commuicatios Hadbook for Cliical Trials

28 Step 2. Ivolve key stakeholders with the dissemiatio of your results. Research shows that fidigs are more likely to ifluece policy ad practice if stakeholders are ivolved i the project from the begiig ad if messages highlight the implicatios of the fidigs for practice rather tha just the eed for more research. Also, the impact of research icreases whe the credibility of the research fidigs are accepted by the users of the study (see Box 6.13). Because people are more likely to trust those like themselves, it ca be helpful to elist stakeholder allies such as key advocates, a respected public health physicia, or a idustry parter as messegers of your results to their peers. Step 3. Take advatage of simple ways to icrease your reach. I the weeks ad moths after your aoucemet, cosider ways to multiply your reach, if you deem it appropriate or desirable. Place short articles about your trial results i the ewsletters of colleague orgaizatios. Sed a short descriptio of the study fidigs to specialist jourals from allied fields ad ecourage them to highlight the results i their ews sectio. Sed reprits of the joural article summarizig the study fidigs, alog with a short persoalized ote, to key opiio leaders i the coutry where your study was coducted. Elizabeth T. Robiso/FHI Coclusio The dissemiatio of a study s results is a opportuity for researchers to expad their collegial etworks, coect with scietists i related disciplies, ad establish mutually satisfyig relatioships with members of the press ad advocacy groups. Dr. Leigh Peterso discusses FHI s oral teofovir trial with ews media at the Iteratioal AIDS Coferece i Toroto. Key poits to remember Dissemiatig study results to a variety of local, atioal, ad iteratioal stakeholders is icreasigly cosidered a ethical obligatio of research ad a key elemet i the collaborative research process. Sceario plaig a exercise to prepare for ad develop messages for a umber of possible outcomes of a study reduces the risk that you ad parter orgaizatios will be uprepared to deal with the implicatios of study results. Dissemiatio activities cotiue log after the day you publicly aouce your results. Pla to moitor media coverage, respod to iquiries, ad iclude iformatio about your study results i public presetatios for weeks ad eve moths after the release. Eve years later, stakeholders should be able to easily locate your study results i the public record, whether olie or i published archives. 113