helps to contextualize the importance of the time and energy that they are putting forth. Sharing progress on major study milestones, such as completing enrollment, as well as any preliminary findings or procedure updates will go a long way toward enhancing and facilitating engagement. You can achieve this by hosting study webinars, distributing a quarterly newsletter( one for participants and one for study staff) or posting updates to a study website.
+ + Express appreciation: One of the most critical components of the retention strategy is to let site staff and study participants know how grateful you are for their involvement. During the planning phase, the retention committee should think through and identify milestones at which to demonstrate a token of appreciation. These might include completion of participant’ s first study visit, conclusion of study enrollment or holidays( e. g., birthdays, Halloween, New Year’ s). Expressions of gratitude can take the form of thank-you cards, coffee mugs or other memorabilia that serve as a reminder of their contribution.
+ + Share study results: Once study analyses have been completed, let site staff and study participants know how and when they can learn about trial results. If possible, post links to any webinars or publications on your study website. Sharing these results with participants is a way to create long-term community engagement and shows individuals how their contributions advanced research. Even if the results are not positive, helping participants understand the lessons that were learned from their involvement is invaluable. Remember the following ethical and logistical factors as you prepare to share study results:
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Outline a communication plan in your study protocol: After consultation with a central Institutional Review Board( IRB), create a strategy for communicating study results to participants that includes how the results will be shared( e. g., via letter, webinar or newsletter).
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Make a commitment to share study results: Although it may take several years from the start of a study for results to be available, study teams must be determined to share results with all participants and develop a plan to do so.
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Consult an ethical review board: Speak with an ethical review board member about what is required to share results with participants after study completion and plan accordingly.
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Request permission for future communication: The study’ s informed consent document should ask participants for their contact information, including email address, and consent to be contacted about study results. Consult your IRB regarding appropriate language for the consent form.
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Develop materials to share results: Decide between individual or mass communication of study results. Use letters or email for individual communication. For mass communication, consider hosting a webinar or posting on a study website. Even if you choose mass communication, create an individual letter, email or phone script to inform participants about the webinar date or publication of results on a website. Although results may not be available for some time, submit the communication materials and strategy to the IRB for approval prior to study closure. Doing so will ensure timely distribution of findings once available.
– – Confirm contact information: For individuals who agreed to be contacted in the future regarding study results, ensure that contact information is up-to-date at the last study visit. Create a secure document to house and easily access this information when study results are available
38 Accelerating Clinical Trials: Best Practices for Recruitment and Retention