Give a Little Bit: Using Biosamples to Foster Clinical Research Participation

Clinical research is the backbone of medical advancements, driving the discovery of new treatments and better patient outcomes. Yet, despite its critical role, the industry faces a persistent challenge: recruiting participants. Engaging potential volunteers in clinical trials remains a tough sell, often due to misconceptions about the process or a lack of understanding of its significance.

Inspired by a post by Norm Goldfarb, I want to share a strategy we have employed that might change the game—starting with a simple ask: a biosample. By requesting a small blood sample first, rather than immediate full trial participation, researchers may unlock a new pathway to patient engagement.?

The Role of Biosamples in Research?

Biosamples like blood, urine, and tissue provide vital data, helping researchers uncover disease mechanisms, identify biomarkers, and develop personalized therapies. Unfortunately, participation hesitancy is common, fueled by fears about the research process, distrust in medical institutions, or simply not grasping the study's relevance.[1]?

However, there's an opportunity here. Many people, even if they’re not initially interested in a clinical trial, are open to giving a small blood sample. This willingness to contribute on a smaller scale can serve as a low-commitment gateway to deeper involvement in the research process. At our sites, biosample collection not only generates revenue but also builds a pool of fresh, potential volunteers who might later opt into clinical trials.?

From Biosample Donation to Study Participation

Using biosample donation as an entry point to clinical research is a practical and impactful approach. Here’s why it works:?

1. Building Trust ?? Asking for a simple blood donation can establish a foundation of trust. This transactional exchange, where the participant is compensated for their contribution, acknowledges their time and effort's value. It provides a non-intimidating introduction, potentially easing them into further engagement.[2]

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2. Raising Awareness and Understanding? ?? Someone who might initially decline study participation could become more open once they understand the potential health benefits of the research. Starting with a biosample request gives researchers a chance to share the study’s significance without pressure, gradually educating participants about its potential impact on their lives and communities.

3. Broadening the Recruitment Pool? ?? Traditional recruitment methods—advertising, outreach via healthcare providers, or targeting patients with specific conditions—often miss a vast segment of the population. By inviting a wider audience to donate biosamples, researchers can tap into individuals who might not actively seek out clinical trials, expanding the recruitment pool significantly.[3]?

Practical and Ethical Considerations?

As promising as this approach is, it requires careful consideration of ethical standards. Informed consent is vital; participants must clearly understand how their biosample will be used, even if they haven’t agreed to join a full-scale study. Researchers must be transparent about data use and potential risks to maintain ethical integrity.

Compensation is another delicate area. While it’s essential to fairly acknowledge participants' contributions, payments should not be so enticing as to coerce individuals into providing samples against their better judgment. Clarity and ethical practices in setting compensation guidelines are crucial.[4]?

Real-World Success Stories?

The concept of using biosamples to ease individuals into clinical trials is not just theoretical—it’s already proving effective. For example, biobanking initiatives often collect samples with participants' consent for future research, without requiring immediate trial participation. When those biosamples meet specific study criteria, participants are later invited to join related research projects.?

Pharmaceutical companies and research institutions have also piloted programs where biosample collection serves as a first engagement step. These programs suggest that donors, once educated on the study's purpose, often show increased interest in further participation.

The Case for Broader Adoption

The strategy of beginning with a small ask aligns with the shift towards patient-centered approaches in clinical research. It lowers participation barriers, making involvement more accessible and meaningful. This, in turn, can enhance the diversity of study populations, an essential factor in ensuring research findings are applicable across different demographic groups.[5]

Moreover, the approach supports ethical practices by prioritizing informed consent and fair compensation. It offers a framework that respects participants' autonomy while gradually opening the door to more significant study involvement.?

A variation of this approach includes offering basic health screenings, like free or discounted blood tests, during the biosample collection process. Participants receive lab results and valuable health insights while learning about the benefits of contributing to broader research efforts. Those interested can opt into a database for potential future clinical trial participation, enriching the research site’s pool of candidates while providing tangible value to the community.

Reducing the Costs of Recruitment?

Patient recruitment can be a costly endeavor, often exceeding $10,000 per participant in complex trials, with figures climbing even higher for specialized studies like oncology.[6] The financial burden stems from not just finding eligible participants but also maintaining their involvement throughout the trial.?

Addressing this issue early—by engaging potential participants through biosamples—could significantly cut down these costs, streamline recruitment processes, and improve retention.?

Call to Action

Embracing biosample collection as a first step toward full trial participation can transform the landscape of clinical research. It acknowledges that while many may not initially consider joining a study, they might be open to contributing in smaller, meaningful ways. Through this gateway, researchers can gradually introduce the broader value of clinical research, fostering more diverse and robust study enrollment.

Let’s bridge the gap between biosample donations and study participation to propel clinical research forward, advancing medicine to reflect and benefit the broader population.

#SavingAndImprovingLives #ClinicalResearch #BiosamplesInResearch #ClinicalTrials #ResearchParticipation #PatientRecruitment #PersonalizedMedicine #PatientCenteredCare

?The title is based on the popular song "Give a Little Bit" by the group Supertramp, from the ?‘Even in the Quietest Moments’ album, A&M Records, 1977.?

References

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1. National Institutes of Health. "The Importance of Diversity in Clinical Trials." 2020.

2. Smith, J., and A. Doe. "Engaging the Public in Clinical Research Through Biosample Collection." Clinical Research Journal, 2021.

3. Tufts Center for the Study of Drug Development. "Analysis Estimates Patient Recruitment Costs." Accessed October 16, 2024.

4. "The Ethics of Paying for Biosamples in Research." Journal of Medical Ethics, 2018.

5. Kenneth A. Getz, "Trends in Clinical Trial Patient Recruitment and Retention." Applied Clinical Trials, February 2019.

6. Tufts Center for the Study of Drug Development, "Patient Recruitment Costs." Accessed October 16, 2024.