Communications Handbook for Clinical Trials: Strategies, tips, and tools to manage controversy, convey your message, and disseminate results


Developing a Strategic Communications Plan

This chapter provides guidance for developing a strategic communications plan for your study. The material in this chapter is presented according to the standard elements of a typical plan (see Appendix 3.1 for an example). A good plan includes strategies for communicating with internal stakeholders (trial staff, sponsors, and funders) and external stakeholders (government officials, journalists, community members, and advocates at the local, national, and international levels).

Your strategic plan should reference a separate “crisis communications plan” for anticipating and managing controversy (see Chapter 5). It should also lay the groundwork for the dissemination of research results (see Chapter 6).

Be prepared to adapt your plan if the circumstances change during the trial. Your activities should be updated regularly to respond to emerging issues or events and to take advantage of new opportunities.

IBackground and environmental analysis

In the introduction to your communications plan, describe the topic and the research study in one or two paragraphs. State why your research is important, and why it is being conducted in this particular community. Summarize background information on the trial’s purpose, methods, and context. You may be able to adapt language from the study protocol for this purpose.

Identify your study’s communication-related vulnerabilities and strengths by summarizing the main findings of your environmental scan (see Chapter 2 for more information on how to conduct an environmental scan). Describe in three or four paragraphs the context in which you will introduce your study, including political or other challenges that could pose a risk to the research project. Opportunities, strengths, or contextual information that could help you achieve your objectives should also be mentioned.

Use all available information sources, including formative research reports, literature reviews, and conversations with colleagues. Briefly note potential issues. Here are some examples:

  • Upcoming elections may result in staff changes at the Ministry of Health, possibly introducing a lack of continuity or support for the trial.
  • A previous vaccine trial conducted at the same site was the subject of sensationalized reporting that accused the researchers of using local women as “lab rats.”
  • Formative research among study participants revealed that some of the women think that participants are assigned to study arms according to HIV status—a misconception that could lead to stigmatization of study participants.

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IIGoals and objectives

The goal of the communications plan is your vision of what you want to accomplish. For many studies, the goal is to explain the research in order to acquire support for the project and to encourage policymakers to apply the findings. Your objectives are the steps that must be taken to achieve those goals.

To develop your communications objectives, you must identify key policy issues, constraints, and problems for which information can serve as part of the solution. Then list your key objectives in relation to the most important issues, such as the dissemination of results, political support for the trial, or visibility for your organization.

The more specific your objective, the easier it will be to determine whether you are on track to achieve your goal. Including a timeline for each objective will help you monitor your progress.

Sample objectives might include the following:

  • To increase understanding among community members of the trial’s purpose, its design, and its benefits to the local community.
  • To improve the accuracy and tone of the media coverage of the trial and of malaria research by local-language newspapers and radio stations.
  • To anticipate and manage controversy related to a tuberculosis vaccine trial by increasing access to balanced information and identifying and responding quickly to misinformation (see Chapter 5).
  • To make the results of a meningitis study understandable to influential advocates and policymakers in countries X, Y, and Z, and thereby help inform national immunization policy in those countries.

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IIIThe communications team

Before the trial began, you should have identified a team with a range of expertise to develop and implement your communications strategy (this process is explained in Chapter 2). You should list the members of your communications team and their roles in implementing the communications strategy in a chart. Include multiple ways to contact each member of your team.

Your chart should highlight the skills and experience of the team members. For example, has the principal investigator (PI) served as a spokesperson for another trial? Did the community liaison officer receive media training? Have team members responded to communications crises in the past? Does the communications officer meet regularly with counterparts from other trials?

You can organize this section by communications function, as shown in Box 3.1.

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IVIdentification of key stakeholders

Determine who needs to know about your trial; write down each name. Whose views and decisions will affect your ability to implement the trial successfully or to promote the application of its findings in the future?

These stakeholders are the audiences for your communications efforts. Typical primary stakeholders at the individual trial-site level include:

  • Study participants
  • Trial staff
  • Study management and sponsors
  • Regulatory authorities and ethical review committees
  • Government officials
  • Community advisory board (CAB) members and community leaders
  • Community-based groups in the host community
  • Colleague organizations and the scientific community
  • National and international advocacy groups
  • Local, national, and international press
  • Donors

In your communications plan, however, you should go beyond these general categories. Instead of defining stakeholders as “Ministry of Health officials,” determine specifically whom you need to reach in the ministry. For example, a plan might outline:

Primary communications audiences for this trial include the Minister of Health; the Director General for Health Services; the Reproductive Health Commissioner; the national and sub-national representatives for programs, training, and service statistics; and facility-level supervisors and clinicians.

Recognize that you have colleagues within your organization or university who will want to know about the trial as it progresses. These stakeholders are part of your “internal audience” and may include any of the organizations that are conducting the trial. For example, it could include the president or chief executive officer of the trial sponsor, the country director of the implementing partner where the trial is being conducted, or other staff members in your institution working on similar trials or programs related to your area of study.

Organize your stakeholders into audience groups. Most trials do not have the resources to develop separate messages and communications campaigns for each of the groups or interested parties who make up your audiences. Fortunately, it is usually possible to combine categories according to the kind of information they need or want, their level of scientific sophistication, and the type of messaging that is appropriate.

An example of audience segmentation by general categories, for an HIV prevention trial, might include:

  • Policymakers and national opinion leaders
    • Minister of Health
    • Deputy Minister of Health, Northwest Province
    • National AIDS Control Committee members
    • National pharmacy authority
    • Minister of Science and Technology
    • Members of parliament interested in science and health issues
    • Regulatory authorities
    • Ethical review committees
  • Sophisticated lay audiences
    • Trial staff
    • Board members, employees, and management of host institutions
    • Funders
    • Advocates and members of nongovernmental organizations (NGOs)
    • Local, national, and international press
  • Scientific audiences
    • Sponsors, trial networks
    • Organizational colleagues and the wider scientific community
    • Leadership of related trials
  • Community members
    • Trial participants and their families
    • Local community groups and community leaders
    • Traditional healers, health workers
    • Community radio

    Figure 3.1 shows another way to group primary audiences for clinical trials.

Figure 3.1. Audience segmentation by external and internal groups

Audience Segmentation

Understanding your stakeholders

Understanding your stakeholders’ values, concerns, and needs will help you communicate effectively. Use information gathered during the environmental scan (see Chapter 2) to create a table that summarizes what you know about the key stakeholders for the trial (see Box 3.3).

Create a different table for each study at your trial site to help identify audiences and their interests. For example, although there will be some overlap, a pre-exposure prophylaxis (PrEP) trial testing a product to reduce HIV infection in men who have sex with men (MSM) is likely to have some different stakeholders than a study testing the same product formulated as a vaginal microbicide in women.

People in each stakeholder group are also communicators in their own right. Some may be opinion leaders who influence the knowledge, attitudes, and behavior of others. If you understand this cascade of influence, you can expand the reach and impact of your communications. Through contacts with their peers, well-informed trial participants, for example, may have an affect on the community’s understanding of the research. Respected policymakers can be enlisted to use the trial’s key messages in speeches and media interviews and to help defuse any controversies that may arise.

See Appendix 3.2 for additional audiences to consider or download the template shown in the appendix.

Developing a detailed contact list

Your contact list can be your greatest asset—if it is well maintained. This list is the tool that will enable you to communicate with your stakeholders.

Here are some tips to ensure that your contact list is complete, well organized, and up to date:

Compile a comprehensive contact list. Include all the stakeholders that you have identified for your trial.

Organize your contacts. Use categories to sort and prioritize your list. The categories might include the primary audiences you have previously identified: Media contact, global opinion-leader, donor, advocate, ethics committee member, community leader, friend of the trial. Box 3.4 shows sample contact list entries. See Appendix 3.3 for a complete contact list or download the template.

Update the contact list regularly. Whether a new government administration has taken over or you have just returned from a conference with 20 new business cards, it is critical to incorporate such new information to keep your contact list current.

Designate and delegate. Assign someone on your team to be responsible for updating the contact list regularly. Remember to notify that person of changes you hear about or new contacts you make. Encourage others on the team to help expand and update the list.

Use a format that works for you. Keep it simple. If your group uses a complicated database that you do not understand, either learn the program or have the information exported into an Excel spreadsheet or Word document.

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VStrategy for ongoing communication with stakeholders

Your plan should describe how you will initiate and maintain communication with internal and external stakeholders throughout the trial. It should include the most important messages you want to convey to each group as well as the strategies you will use to do so. Of course, both your messages and strategies will change over time. Your communications plan should be a living document that evolves as circumstances change and the trial progresses.

Developing messages

List three or four important messages about your trial that you would like to convey to stakeholders. These messages usually address:

It’s helpful to separate out in a communications plan, first the content of what you need to communicate; secondly, the strategy for how you will communicate your messages; third, how to adapt the factual information for different audiences; and fourth, being sure to have the right messengers for each audience.

—Manju Chatani-Gada, MPH, Senior Program Manager, AVAC: Global Advocacy for HIV Prevention

  • The purpose of the trial and its potential benefits
  • The fact that the product or intervention under study is of unknown effectiveness
  • The measures taken to protect the safety of participants
  • The possible risks and benefits of trial participation

See Chapter 7 for more guidance on developing messages. You should refine these messages and develop supporting messages as the trial progresses. More key messages will be needed for specific situations or events and when results are available for dissemination.

Communications channels and approaches

Your environmental scan (see Chapter 2) will provide information about the best ways to communicate with internal and external audiences. During site preparation meetings, for example, stakeholders can be asked how they would like to be kept informed of the trial and how often they would like to receive updates. Some stakeholders may prefer to receive infrequent e-mail alerts or quarterly written reports, whereas others may want to meet periodically with trial staff to ask questions about the trial. This information can be captured in your contact list.

Let stakeholders’ preferences—about the type and frequency of information provided and the channels used to convey that information—guide the development of your strategy. You may choose to use different strategies at various stages of the trial. For example, media outreach might be narrowly targeted to educate a few trusted journalists at the beginning of a trial but then gradually expanded to build understanding of the trial among a larger cadre of journalists through media workshops in preparation for the dissemination of results to local, national, and international media.

You may also opt for a staged strategy, where you map out whom you will approach first and the order of subsequent contacts. This may use peer-to-peer networks, or be based on a cascade model of influence. For example, if you are studying a new influenza vaccine and you know of a well-known expert on influenza, you might talk to her first, recognizing that the media and policymakers frequently seek her opinion.

Plan for a regular flow of information instead of one-time announcements, and add activities over time. Be proactive and initiate a dialogue that builds trust.

Activities plan

Translate your communications strategy into an action plan that lists activities, messages, and timing for each audience (Baeyaert 2005).

Identify milestones for your trial and other related trials, and plot these on a timeline. Although regular communications throughout the study are important, there are key milestones that require special attention. These include the launch of the trial, the completion of participant enrollment, interim analyses by an independent data monitoring committee (IDMC) that could recommend modifications or a halt to a study, and the release of the study’s results. A timeline of these milestones (see the first item in Box 3.5) can be a useful planning tool.

Figure 3.2. Key milestones of a rotavirus vaccine trial

Key Milestones of a rotavirus vaccine trial

Consider inviting journalists or other stakeholders to visit the trial site at appropriate milestones.

Remember that important events in related trials—in your region, country, or another part of the world—may still affect perceptions of your own research. For example, the closure of a microbicide or vaccine trial—whether for futility, harm, or benefit—is likely to raise questions about other HIV prevention research.

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VIStrategy for managing controversy—crisis communications

Experience shows that at least one problem, controversy, or crisis is likely to occur at some point during your trial. Clinical trials can be difficult to understand, and research on certain topics is inherently controversial—particularly when trials are designed to test unproven interventions in healthy volunteers. Therefore, you must be prepared to respond quickly to misinformation or unexpected events that could jeopardize your trial.

By anticipating which issues are likely to be controversial or misunderstood, and by addressing them early on in a straightforward and comprehensive way, you can prevent potential crises.

Your strategic communications plan should include a short section summarizing your plan for dealing with controversy. If you expect controversy, you will also need to develop a more detailed crisis communications plan to help you manage emerging issues (see Chapter 5).

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VIIDissemination plan for trial results

As you implement your communications strategy, you will build the tools, processes, skills, and resources that you will need to disseminate the results of your trial. Your overall communications strategy should summarize your plan to share results with trial stakeholders. Later, you will need to develop a separate and more detailed dissemination plan.

It is important to outline the basic dissemination plan early in the trial so that you can budget for essential activities such as holding dissemination meetings for community members and other local stakeholders, presenting at conferences, and writing journal articles. As the trial progresses, this plan will evolve.

Chapter 6 offers guidance on developing a dissemination plan that includes strategies for communicating results to different audiences, activities, timelines, and materials to be developed. The scenario planning described in Chapter 6 will help you prepare for the dissemination of the trial’s final results by developing strategies and messages for a number of possible study outcomes.

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VIIIMaterials to support the trial

Your plan should include a list of the materials that you will develop to support the trial. Box 3.5 presents a template for tracking the status of these materials. Every study should put together the following core package of materials:

External documents for distribution to stakeholders

Backgrounder. This is a one- or two-page summary of the “who, what, when, where, and why” of the study. It should explain the research questions being addressed in clear language without research jargon. (See Appendix 3.5 for a sample backgrounder.)

External questions & answers (Q&A) document. The Q&A should address common questions about the trial and its design, the research intervention, and the sponsoring organizations. External Q&As should also include general information on the disease or condition studied. Questions should be kept short and answers should be limited to one paragraph. If an answer needs to be longer, consider dividing it into two or more separate questions. Again, use clear language without research jargon. (See Appendix 3.6 for a sample of an external Q&A.)

Stand-by and internal documents for staff use only

Talking points/key messages. This document should include the key messages developed for your study (see Chapter 7), and any tailored messages developed for particular trial sites.

Internal Q&A. This question and answer document is similar to the Q&A listed above, but it tries to anticipate and address controversial issues and common misconceptions about your trial. Its purpose is to provide talking points about such issues for trial spokespeople. This document should be updated to address any issues or misconceptions that arise during the trial. For sample questions to include in internal Q&As, see Appendix 6.4.

Holding statement. This is a press statement that contains basic information about the study, including a contact name and information about your spokesperson(s), study, and organization. It usually includes blank spaces where pertinent information about an unexpected event or situation can be filled in at a moment’s notice.

Spokesperson “bios.” One- to three-paragraph biographies of all of the trial spokespeople should be prepared and made available to journalists or other stakeholders upon request.

Other materials. You may also want to develop a study newsletter (see Appendix 3.4 for example), brochures, press releases (see Chapter 9), electronic alerts, resource lists, training materials, slide presentations, posters, and flyers.

In resource-constrained countries, many stakeholders will need printed materials. Provincial and district health officials, for example, often do not have reliable Internet connections or even access to computers. In such instances it is best to hand-deliver copies of key documents and get signed proof of delivery.

Pre-test your materials with members of your target audiences before you produce or distribute them and use the audience feedback to ensure that the materials convey your messages effectively.

Some national-level decision makers may have access to reliable Internet services, but may prefer to receive information about the trial electronically.

All materials should be written in clear, accessible language; nevertheless, messages and materials will need some adaptation for different audiences. For example, a slide presentation at a scientific conference might contain the same basic information about the trial as a presentation to a nonscientific audience, but it might provide extra details and use some technical language. Some materials may also need to be translated into local languages.

It is important to pre-test your materials with members of your target audiences. Show members of each target audience drafts of the materials that have been designed for them and ask them to respond to questions about content, language, and format. This can be done through group discussions and interviews or written questionnaires. Your goal is to determine whether target audiences understand the material and how to make it more useful and relevant to specific audiences.

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IXMonitoring and evaluation

Monitor results at pre-agreed stages and adjust elements of the plan and the means of measurement if necessary. Ask: What should we continue doing? Stop doing? Adjust?

—(Baeyaert 2005)

Monitoring is essential for the early identification of potential problems and to ensure the effectiveness of trial communications. The information you gather through monitoring can help you refine messages and approaches and measure progress toward achieving your objectives.

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Key Points to remember

  • Start developing your strategic communications plan early, and refer to it for guidance throughout your study. Your plan will be a living document that evolves as circumstances change, new opportunities arise, and the trial progresses.
  • A good plan includes strategies, activities, and approaches for communicating with your audiences throughout the trial. Your audiences are the internal and external stakeholders that your team identifies as important to your trial.
  • Your overall communications strategy should summarize plans for how your study will deal with controversy, disseminate trial results, and monitor and evaluate communication activities.

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How to Use this Handbook


Planning Communications (Video)

Planning Communications

Developing a Strategic Communications Plan (PPT slides and notes)

Developing a Strategic Communications Plan


Appendix 3.1

Sample Strategic Communications Plan (PDF)

Appendix 3.2

"Getting To Know Your Stakeholders" Template (PDF)

Appendix 3.3

Contact List Template (PDF)

Appendix 3.4

Samples of Newsletters for Clinical Trials (PDF)

Appendix 3.5

Sample of Study "Backgrounder" (PDF)

Appendix 3.6

Sample External Questions and Answers (PDF)