Phase 1 trials mark the first step in the clinical stage of the journey from laboratory discovery to medical treatment. In these early-phase studies, healthy volunteers play a crucial role. However, understanding the psychology behind their participation is essential for effective recruitment and retention. In this blog, we’ll explore the motivations and concerns behind trial participation, and the strategies study sites employ to enhance phase 1 recruitment.

What motivates healthy volunteers to participate in phase 1 studies?

For many healthy volunteers, altruism is a significant motivator. The desire to contribute to medical advancements and help others often drives participation.

Alternatively, some individuals are drawn to the opportunity to have thorough health screenings and medical check-ups. This benefit can be particularly appealing for those without regular access to healthcare.

Finally, financial considerations can also play a crucial role. The monetary compensation for time spent participating in phase 1 trials can be a driving force for healthy volunteers, providing a tangible benefit, particularly for students, part-time workers, or those in between jobs.

Common concerns of healthy volunteers

Despite these motivations, potential volunteers might have some hesitation around participating. Often, the primary concern is the risk of adverse effects. Many phase 1 trials involve the first administration of a product to humans, which naturally raises questions about safety. The invasive sampling and testing required for participation can also deter volunteers. Moreover, some trials require extensive time commitments with lengthy stays in clinical units and multiple follow-up visits that might prove challenging, especially for those with inflexible schedules or personal commitments.

So, what can you do to help alleviate these concerns and drive successful recruitment of healthy volunteers?

Phase 1 recruitment strategies

While CROs manage the logistical aspects of trials, clinical trial sites, including phase 1 units, are responsible for direct contact with trial participants. Close collaboration between sponsors, CROs and sites is essential to improving phase 1 recruitment and ensuring the best approach is agreed to early, so that ethics committee approvals can be finalised.

While most phase 1 units and private clinical trial sites have extensive databases of potential healthy volunteers and some patient groups, here are other tactics that your site can employ to drive participation.

• Targeted outreach: Discuss use of social media, networks, and community centers to effectively reach potential volunteers. Leveraging digital platforms like Facebook, Instagram, and LinkedIn can expand your site’s reach, while partnerships with universities and local organizations can help reach motivated and community-oriented individuals. Carefully prepared messages that provide simple information and are agreeable to the ethics committee are critical.
• Transparency and education: Your site should provide clear, detailed information about the trial, including risks, benefits, and the study’s importance, which will help build trust. Developing comprehensive and easily accessible resources, such as brochures, videos, and infographics, can make complex information more digestible. Hosting educational sessions or Q&A forums, both online and in-person, can demystify the process and encourage participation by directly addressing potential volunteers' questions and concerns.
• Supportive environment: When selecting the trial site/s, ensure they create a welcoming and supportive atmosphere to help recruit and retain healthy volunteers. Friendly staff, comfortable, accessible facilities, and regular check-ins can make volunteers feel valued and respected.
• Feedback and follow-up: Ensure your trial site/s regularly seek feedback from participants post-trial to  identify how to improve the volunteer experience and foster long-term engagement. Positive experiences shared by past participants can be powerful testimonials for future phase 1 recruitment.
• Psychological support: For very challenging trials, you may wish to look for sites that provide psychological support for participants to address any anxiety or concerns they may have about participating. While the consent process for trial participation always involves talking to a medical professional and someone who is not part of the trial team, additional access to counselors or support groups can help volunteers feel more comfortable and supported throughout the process.

Recruiting healthy volunteers for phase 1 clinical trials involves more than just finding good sites with willing participants; it requires a deep understanding of people’s motivations, fears, and decision-making processes. By leveraging psychological insights in trial design and employing targeted recruitment strategies, you can enhance participation rates, ultimately advancing medical research and bringing new treatments to market.

If you want to learn more about how you can successfully navigate clinical research in Australia with a team of professionals committed to safe and ethical studies, get in touch with us today.

Southern Star Research is a full-service Australian Contract Research Organization. We help sponsors run safe and efficient trials that meet regulatory requirements, ensure scientific excellence, and demonstrate the commercial viability of your product. If you're looking for an agile and dedicated team to help you run a successful trial, contact us today.