Collaborating To Improve Patient Participation In Research
The Michael J. Fox Foundation’s experience with clinical trial recruitment.
Clinical trial recruitment is a challenge across all diseases, leading to underpowered studies, increased trial costs, and, most significantly, delays in the development of therapies that patients and their loved ones need. Improving patient recruitment has been a long-time priority of The Michael J. Fox Foundation for Parkinson’s Research (MJFF). Through our experience supporting funded studies and sponsoring the large-scale Parkinson’s Progression Markers Initiative, we have come to understand that meeting enrollment goals requires that all stakeholders— physicians, sponsors, funders, site personnel and patients—work together to raise awareness of the problem and implement strategies to increase research participation.
RAISING AWARENESS AND PROVIDING ACTION STEPS
Generating widespread awareness about the critical need for research volunteers and initiating patient interest in clinical trials is, in our experience, a necessary first step toward addressing poor participation. Opportunities for research participation should be part of the dialogue a patient has with all groups connected to their disease, including physicians, advocacy organizations and health care associations. The patient community should be informed of the important role they play in finding disease cures and better treatments. Conversations and educational materials ought to include information on what it means to participate in research, the informed consent process, and regulatory and patient protections that govern research.1
However, general knowledge is not enough to spur action. Patients and healthy controls need access to information about specific, recruiting trials. Unless one is able to identify trials underway, find a participating site nearby and contact a research coordinator, awareness and education will have a limited impact on recruitment. Further, it is important that study goals and eligibility criteria are presented in a clear and concise manner.2 Awareness and education efforts should always to include a clear “next step” a patient can take if they are interested in research participation.
REFERRING VOLUNTEERS AND CORRECTING MISCONCEPTIONS
Low awareness of the need for trial volunteers may stem from the fact that research opportunities are not part of the standard dialogue between a patient and treating physician. If a physician is not involved in clinical research him or herself, the likelihood that he or she will even broach the topic of trial participation with a patient is far diminished.3 These discussions as part of standard patient care are critical to heightening volunteer interest and conducting clinical studies.
Addressing common misconceptions about trial participation is also an important part of the physician-patient dialogue. An informal survey conducted in 2012 by MJFF of 832 Parkinson’s patients demonstrated some of these misbeliefs: 46 percent stated they believed that “patients in clinical trials are guinea pigs,” 32 percent believed that participating in a trial meant exposure to experiments they did not agree to and 33 percent thought that participation in a trial would interfere with their usual care. Helping patients more accurately understand the clinical trial experience is, in our opinion, an important step in breaking down barriers to participation.
COLLABORATING ON RECRUITMENT STRATEGIES
Our experience has shown that one of the most crucial steps in meeting recruitment goals is organizing a trial recruitment committee comprising coordinators, investigators and patients. Such a group serves to inform and monitor recruitment strategy from the outset, and, if necessary, devise a rescue strategy if recruitment is not progressing well. This committee can be particularly valuable in contributing to recruitment materials and brainstorming new outreach mechanisms, particularly for multi-site studies. Committee members from different sites should report on and share identified “successes” through a regular check-ins, such as a monthly call.
Once a trial recruiting infrastructure has been established, sites can then focus on converting “leads” to enrolled trial participants. Defining who should be referred for screening is an important starting point. MJFF found that distilling a few critical characteristics of the target population helps referring physicians and leaders in the disease community remember who to target. A simple summary rather than a full list of inclusion/exclusion criteria better enables those not directly involved in the study to refer individuals who may qualify for the trial.
SETTING STUDIES UP FOR SUCCESS
MJFF supports clinical studies it funds with trial recruitment expertise and resources. Those tactics informed the strategy around the Parkinson’s Progression Marker’s Initiative (PPMI), an MJFF-sponsored landmark biomarkers study of 400 early-stage Parkinson’s patients and 200 ageand gender-matched controls.
PPMI (www.ppmi-info.org/) launched in 2010 and met its recruitment goal in April 2013. On average, once a site was activated, it fulfilled its enrollment objectives within 26 months. To address and help mitigate potential hurdles to enrollment, PPMI leadership established a recruitment committee of 14 site investigators and coordinators that met on a monthly basis. A patient committee was also established to brainstorm and help evaluate recruitment ideas. Further, Parkinson’s patient and physician “salons” were organized near trial sites to educate communities on the study and the potential impact of identifying a Parkinson’s biomarker.
In an effort to reduce barriers and arm interested volunteers with actionable steps toward participation, MJFF launched Fox Trial Finder (www.foxtrialfinder.org) in 2012. This online tool matches interested volunteers—patients and control volunteers—to Parkinson’s research studies based on geography, medical history and other variables.
Fox Trial Finder has amassed a database of more than 28,000 interested volunteers (76 percent Parkinson’s patients) and between 400 and 500 actively recruiting trials. To date, nearly 500,000 matches have been generated between potential participants and recruiting trials and nearly 17,000 messages have been sent between interested potential participants and trial teams. Positive reactions from the Parkinson’s community to Fox Trial Finder have reinforced the notion that patients want to be engaged in research and see themselves as active and equal stakeholders in the clinical research arena.
Every constituent involved in clinical research—from physicians to study sponsors, clinical sites and advocacy groups, and research volunteers themselves—has a role to play in the recruitment process. We recognize that our experience with PPMI and Fox Trial Finder may not be wholly applicable to other diseases; rather our experiences provide a set of recommendations for the research community to consider when thinking of recruitment strategies. We believe that ongoing research and the sharing of best practices and lessons learned across disease states will better equip the entire research community to address the challenge of timely research recruitment.
Cameron P, Pond GR, Xu RY, Ellis PM, Goffin JR. A comparison of patient knowledge of clinical trials and trialist priorities. Curr. Oncol. 20, 193-205 (2013). Patel MX, Doku V, Tennakoon I. Challenges in recruitment of research participants. Adv. Psych. Treat. 9, 229-238 (2003). Kaplan CP. Napoles AM, Dohan D et al. Clinical trial discussion, referral and recruitment: physician, patient and system factors. Cancer Causes Control 24, 979-988 (2013).
- Cameron P, Pond GR, Xu RY, Ellis PM, Goffin JR. A comparison of patient knowledge of clinical trials and trialist priorities. Curr. Oncol. 20, 193-205 (2013).
- Patel MX, Doku V, Tennakoon I. Challenges in recruitment of research participants. Adv. Psych. Treat. 9, 229-238 (2003).
- Kaplan CP. Napoles AM, Dohan D et al. Clinical trial discussion, referral and recruitment: physician, patient and system factors. Cancer Causes Control 24, 979-988 (2013).