Partnering with Research Participants
Overview
Clinical trial participants are the backbone of clinical research, and there is a great responsibility on researchers and trialists to promote collaboration and ensure participants feel respected, included and engaged throughout all parts of the research cycle.
The Partnering with Research Participants Professional Interest Area (PIA) for researchers and clinical trial participants within the Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment (ISTAART) works to identify opportunities to increase trust and engagement with research participants. The Partnering with Research Participants PIA works with existing PIAs and leverages existing groups to ensure broad access and applicability of their findings.
Pathway to inclusive dementia research
Partnering closely with communities helps researchers understand where obstacles exist and further prove themselves as trusted partners. Researchers first must understand the stigma of aging, which is much worse for those with a diagnosis of dementia. The impact may be even greater for people who have dealt with discrimination for their entire lives because of their skin color, religion, gender identity or abilities.
An article by the Partnering with Research Participants PIA published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association aims to help researchers understand how best to partner with communities to encourage and advance dementia research that is inclusive and brings in people from all walks of life. Co-authors include professional researchers together with five community members from five countries (The Netherlands, Ireland, United Kingdom, Australia and the United States) with lived experience of dementia and aging research.
The authors emphasize that meaningful partnerships for inclusive dementia research are built on choice, respect, shared decision-making, access, inclusion and representation. They propose more researchers embed public voices into the research process. This is a path toward increasing the odds of successful and sustained engagement with participants, and possibly greater future acceptance.
Recommendations for public and participant involvement (PPI) in dementia research
- Establish a partnership with choice and shared decision-making. Ground partnership by valuing the needs, lived experience and expertise of the community participants.
- Ensure equal access. Ask for input on how to make interactions effective and accessible, including how group is structured and settings for interactions.
- Start early, but it's never too late to engage. PPI input can influence the focus and priorities of research, so it's best to start partnerships early in the process of research.
- Ensure representation and respect differences. Be intentional in composing your group, ensuring voices not commonly heard are given space. Avoid single representatives or scenarios in which PPI are outnumbered by researchers.
- Discuss and define terms, titles and roles. The language we use demonstrates partnership, discuss with the community, and avoid acronyms and "academic speak."
- Encourage storytelling. Storytelling is a legitimate method of sharing wisdom, and patient stories are an important piece of evidence to inform care.
- Share impact. Summarize for both community and researchers the impact of PPI on research and involve PPI in dissemination of learnings to both general audiences and scientific spaces.
- Demonstrate appreciation. Ask what incentives would best show appreciation and would be meaningful and helpful, such as a financial honorarium or a certificate or public acknowledgement; this will differ across communities.
- Offer training to support co-learning. Training can benefit and empower both PPI members and researchers, but make sure training is not a barrier to participation.
- Listen and keep listening. Feedback from PPI will clarify understanding on the part of both researchers and community.
- Respect confidentiality and privacy. Assure PPI that their input will be kept confidential and anonymous.
- Demonstrate long-term commitment. Make long-term plans, work toward short-term goals, and plan together with community.
Participant FIRST
The Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Workgroup was created to improve communication with research participants and study partners in the event that a clinical trial ends early or ends as planned. The multidisciplinary work group included research participants and their study partners, researchers and study personnel, as well as representatives from academia, industry, patient advocacy organizations and the National Institutes of Health. Members meet regularly to describe the central issues, define the limitations of current approaches, and develop and refine recommendations.
Two articles published in Alzheimer's & Dementia®: The Journal of the Alzheimer's Association provide background and recommendations on how to improve communication with research participants and their study partners in the event a trial is discontinued or ends as planned:
- Putting participants and study partners FIRST when clinical trials end early
- Supporting participants and study partners when trials end as planned
Learn more: When Clinical Trials End
Participant FIRST Workgroup recommendations
Pre-trial
- Sponsors and funders should provide resources and funding in the study budget to ensure orderly trial closeout.
- Sponsors or principal investigators should ensure that the communication plan developed for the trial addresses the possibility of early stoppage.
- Study personnel must address the possibility of early stoppage during the informed consent process.
- General information about early stoppage should be available to members of the public.
- Study personnel should encourage participants and study partners to build and sustain their support networks.
Mid-trial
- Study personnel should regularly check and update contact information for participants and study partners.
- Study personnel should remind participants and study partners that clinical trials might end early.
- Sponsors and principal investigators should anticipate and proactively address participants' and study partners’ questions and concerns when there is news from related clinical trials.
Post-trial
- If a sponsor announces study results via a press release, that press release should explicitly address participants and study partners.
- The sponsor or principal investigator (PI) should communicate news of topline study results to site investigators and study personnel.
- Study sites should initially contact participants via email as soon as possible.
- Study personnel for other studies should proactively reach out to participants and study partners to address the results, too.
- Study personnel should call participants and study partners and personally inform them of trial results.
- Sponsors, principal investigators, and study sites should consider leveraging social media to disseminate consistent information about study results to participants and study partners, as well as to the wider public.
- Sponsors and principal investigators should collaborate with patient advocacy organizations to support participants and study partners when trials end.
- Sponsors should prepare answers to frequently asked questions (FAQs) and disseminate them broadly.
- Site investigators should invite participants and study partners to a personalized closeout meeting to cover information like participant arm assignment, if one has not already been offered.
- Sponsors, principal investigators and sites should collaborate to ensure full results are shared with participants and study partners.