Healthy volunteers are a cornerstone of successful clinical trials. Before medications or devices are given to patient groups with a specific condition, interventions on healthy volunteers set a baseline in the early stages of clinical research. These control groups ultimately pave the way for innovative treatments.
While the value of healthy volunteers in clinical trials is clear, what’s not so clear is how to find them. As Policy Lab notes, “[U]nlike people with chronic conditions, healthy volunteers generally don’t seek out the chance to participate in clinical research studies, and may not even know about them.”
This is one aspect of what makes it difficult to track down healthy volunteers for clinical trials. But there are other variables at play, too.
Eligibility Criteria Is Too Stringent
The goal of eligibility criteria for clinical trial patients is to prioritize safety. But in some cases, this criteria becomes stricter than it needs to be. If age restrictions are too narrow or even minor medical conditions exclude individuals from trial participation, the pool of healthy volunteer candidates becomes even smaller.
While assumptions can help drive the development of eligibility criteria, data should round out decision-making. In the early stages of one study’s design, a team’s analysis of real-world data indicated a strict age criteria would exclude one-third of their potential participant population. In subsequent conversations with experts in the therapeutic area, the team was able to expand the base to include older participants without any concern.
Broadening eligibility criteria also supports a more diverse clinical trial population, which has become the standard in clinical trial design based on FDA guidelines. In the words of FDA health science policy analyst Atasi Poddar, the “FDA wants patients to know how important it is that clinical trial participants reflect the diversity of the people across our nation who will be taking the medication, if approved.”
By ensuring that underrepresented populations participate in studies, you can reduce health disparities that might have otherwise ruled out healthy volunteers. Materials and communication strategies should align with these guidelines to create a more inclusive environment that encourages increased volunteer participation.
Too Much of a Time and Resource Commitment
A survey from the Center for Information and Study on Clinical Research Participation (CISCRP) looked at factors that cause patients to drop out of clinical research studies. 44% of patients reported traveling to the clinic as “somewhat” or “very” burdensome. 40% of patients said the same about the length of the study visits.
These inconveniences and demands can be a sticking point for patients with conditions to participate in trials. In the context of healthy volunteers, there is even less incentive.
The need for a more flexible framework ties back to the COVID-19 pandemic. As stated in a Clinical Trials Arena article, “while the surge in decentralised [sic] trials could witness a slight decline in uptake, the broader focus on adaptive trial design is here to stay.”
Simplifying protocols allows for adaptation without the need for new approvals that can lead to delays. If a trial volunteer can’t drop off their sample due to a work commitment, there’ll be flexibility to pick it up. The same goes for if a volunteer is sick but they need a new charger for their study diary. A site coordinator can get the go-ahead to drop it off.
These measures go a long way in making trial participation more convenient for healthy volunteers. The same goes for a rapid enrollment process and proactive communication that minimizes wait times at facilities.
Tap Into Our Expansive Volunteer Database
Tracking down qualified volunteers for clinical trials can be a challenge. Partnering with Remington-Davis, an experienced clinical site in Columbus, Ohio, takes this weight off your shoulders. With an expansive database of nearly 16,000 patients, we can readily locate healthy volunteers that are a good fit for your research study.
Rapid enrollment is just one aspect of our patient-centric service. We are a leader in decentralized trials and can quickly adapt to provide convenience to patients as study protocols allow. Our dedication to creating a positive patient experience is underscored by our 98% patient retention rate.
Learn more about how we can support your clinical trial needs. Contact us for a consultation.