Clinical trial safeguards have significantly improved over the last 50 years. The National Research Act, signed into law in 1974, established Institutional Review Boards (IRBs) to protect patients and increase public trust.
In 1991, The Common Rule was adopted, requiring researchers to get informed consent from trial participants. It also spelled out rules for providing patients with information they could use to make an informed decision in simple language that they could understand.
Enacting these safeguards was essential for transparency purposes. After historical wrongdoings like the case of Henrietta Lacks and the Tuskegee Syphilis Study, many Americans –– particularly members of minority populations –– distrusted the medical establishment and were hesitant to enroll in any type of clinical research.
Fortunately, some of this stigma has subsided. Over the last two decades or so, biopharmas have made great strides to build trust, recruit more diverse patient groups, and implement equitable protocols. But even with all this, many trials fail to recruit the necessary participants to move forward. There are various reasons for this, but one that’s often overlooked is a lack of community engagement.
In a recent article by Clinical Leader, contributing editor Tyler Menichello interviewed Dr. Ken Ho, MD, MPH, of the University of Pittsburgh Medical Center. Dr. Ho specializes in HIV research, but he’s also had great success recruiting patients for clinical trials. In 2022, he increased enrollment in the Pitt Men’s Study — a multicenter, NIH-funded study of HIV/AIDs –– by 35% in just six months.
Several factors contributed to this success, but Dr. Ho credits community engagement as the key to this achievement. Below, we take a closer look at Dr. Ho’s approach and explain how to include it in your own recruitment efforts.
The Power of Meaningful Connections
To successfully recruit patients, you need to build trust within certain communities and populations. Targeted advertising and clear messaging go a long way toward achieving these goals, but they’re nowhere near as impactful as face-to-face interactions.
When developing a recruitment strategy, think about all of the places you might be able to interact with your target audience. That might include:
- Health fairs
- Donation drives
- Silent auctions
- Heritage celebrations
- County or State Fairs
- Farmer’s Markets
- Parades
- Cultural festivals
- City council meetings
- Virtual meetings with community leaders
Attending these types of events won’t necessarily guarantee a flood of trial sign-ups, but it does establish your presence in the community. And, the more you make your presence known, the more likely people are to approach you and ask for additional information.
To make these efforts even more successful, ask the professionals conducting the research to attend these events with you. That way, when community members have questions, a qualified expert is there to provide answers.
Demonstrate Trustworthiness Through Action
Only 34% of Americans say they trust the medical profession. Factors like the COVID-19 pandemic and the increased politicization of everyday life have undoubtedly contributed to this mistrust. But there have always been problems with lack of representation, barriers to quality care, and discrimination and bias.
All of these things make it incredibly difficult to build trust with potential trial recruits. Again, Dr. Ho recommends taking a novel approach –– hosting “town hall” meetings.
A town hall presents an opportunity for community members and community leaders to ask researchers and clinicians about all aspects of a study. Likewise, it provides the chance for researchers and clinicians to explain the benefits of the research and the steps they’re taking to include diversity, equity, and inclusion in the recruitment process.
The benefits of community meetings go far beyond simple question-and-answer sessions. They let people who might not know anything about clinical research learn more about how it works. They also allow people to discuss their worries, fears, and concerns.
The people conducting the research can then answer these questions in real-time, a simple act of transparency that goes a long way toward building trust.
Successful Recruitment with the Community’s Help
Finally, Dr. Ho suggests that sponsors build strong relationships with physicians, nurses, and other healthcare providers in the community.
These professionals work with patients one-on-one every day. They have a comprehensive understanding of different factors that prevent people from enrolling in clinical trials and can use that knowledge to ease fears and educate potential participants.
Generally speaking, patients are more likely to trust their primary care physician or another provider they regularly interact with, compared to sponsor representatives who are strangers. Though it takes time and effort to build these relationships, the benefits in terms of patient recruitment are undeniable.
Patient Recruitment Isn’t a Passive Process
Automation, artificial intelligence, and trial decentralization have all contributed to a more mechanical recruitment process. That isn’t to say these tools aren’t without benefits, but when it comes to identifying and enrolling trial participants, the human element is essential.
By getting involved in the community, taking time to listen to patients’ concerns, answering questions, and earning trust by partnering with healthcare providers on the front lines, you can make recruitment less challenging and break down some of the long-established barriers to successful enrollment.
There isn’t a right or wrong way to do this. Simply take the first step and be willing to try new approaches. By actively participating in the recruitment process, you’re bound to see positive results.
