Across the clinical research industry, “patient-centricity” has been a focal point for enrollment but that’s no longer enough. We need to be talking about “participant engagement,” which better reflects the integral role participants play in the entire research process.
Engaging participants and cultivating trust is increasingly critical to clinical trial success, especially as trials become more complex. We need their insights.
Over the last decade, Phase III trials saw a 70% increase in procedures and a 300% increase in data collection points. These trials require more resources and personnel at a time when many healthcare organizations are trying to control costs and asking departments to do more with less. In addition,
- Only about 5% of participants enroll in clinical trials
- Only about 3% of physicians participate in clinical trials (and our five-year trends suggest that’s on the decline)
- Nearly 70% of sites miss enrollment targets and deadlines
- Approximately 15% of sites fail to enroll a single person
It’s no surprise, then, that sites are turning to outsourcing and partnerships. Collaborative efforts, such as site networks, consortiums, and partnerships with research service organizations can ease the administrative burden, allowing sites to devote their limited resources to patients and participants.
Start at the Beginning
To engage potential participants, we need to understand what motivates them to join a clinical trial. For some people, a clinical trial is a way to receive treatment—if not curative, at least treatment that will halt or slow disease progression or reduce symptoms. For others, participating in research offers them the opportunity to be part of something bigger, to move science forward, and to leave a positive legacy for future generations. Neil Armstrong once observed that “Research is creating new knowledge.” Many who participate in clinical trials want to do just that.
Create Participant Advisory Boards
Understanding motivations is merely the first step. Ideally, you want to engage patients and other potential participants in protocol development.
A patient advisory board (PAB) can provide first-hand expert insights on a disease, which can inform protocol design and execution. Incorporating participant perspectives during protocol development can result in more meaningful outcomes, reduced burden, and optimized trial processes. Yet, only 8% of protocols utilize a PAB, according to Tufts Center for the Study of Drug Development.
That 8% saw the benefits: Protocols developed with the insights of a patient advisory board had simpler protocols and more targeted designs. They reported
- 30% reduction in clinical endpoints
- 20% fewer inclusion/exclusion criteria
- 50% reduction in the amount of data collected
Engaging your PAB in a 360-degree review of your protocol can help you identify ways to make a trial more efficient, less burdensome and more accessible.
Ensure Equitable Access
Insights from participants can help sites and sponsors
- Meet patients where they are: Academic medical centers account for 70% of trial placements. However, only 15% of patients seek care at these centers. That’s why it’s important to engage potential participants in their local communities and through patient-advocacy groups.
- Make technology accessible: For many participants, high tech will fail without high touch. For example, eDiaries, despite their benefits, can be difficult for some patients to use. Yet, hybrid trials give participants more flexibility, allowing them to have some of their visits from their home—if they can use the remote technology. Finding a balance between high-tech and high-touch ensures participants aren’t left behind in the transition to decentralized trials.
- Identify and address disparities: Considering the needs of different populations, including members of racial and ethnic groups, those in rural areas, and the elderly, is crucial to ensure equitable access to trials. A diverse PAB can provide the insights needed to meet diversity, equity and inclusion goals.
Building Trust: Education and Communication
Retention may be even more important than enrollment: The participant dropout rate is approximately 19%, and the top reason these former participants cite is poor communication with the study site.
Communication builds trust, and trust enhances communication. This trust, nurtured by physicians and research coordinators, helps ensure participants feel involved, informed, and reassured that their questions will be answered. Put another way, participant engagement means providing the right information to the right person at the right time.
- Respond to questions: Cultivating trust begins with listening to questions and finding answers. A simple “I’m not quite sure, but let me look that up for you” instills confidence (provided the participant eventually receives an answer).
- Recognize the importance of every interaction: Each encounter with an investigator, a clinical research coordinator or other staff member is a decision point for the participant. “Am I, based on this particular encounter that I have had today, still willing to participate in the clinical trial?” That’s a decision that the participant makes every time they come in for a visit or interact via video or phone.
- Provide accurate information: This takes on many forms. It could involve explaining when and why a placebo is used or correcting what a potential participant heard from a friend who heard it second hand. Communicating clearly and accurately about clinical research—and correcting misinformation–isn’t just about convincing someone to enroll or bolstering retention: We’re building disciples of clinical research by giving the correct information for the participants to be able to spread the word.
- Be transparent: Timely communication of trial results to participants reinforces the impact of their contributions and can provide closure. Sharing these results—positive or negative– with the public is also essential to fostering trust in clinical trials.
Participant engagement involves understanding why a person is participating in the trial, providing them with the information they want and need, and soliciting their input in trial design and execution. Clear communication before, during and after the study can bolster enrollment and retention. It also fosters willingness to participate in additional studies. Remember, we’re not just enrolling participants into one study: We’re continually building trust in clinical research.
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