Diverse Recruitment Strategies and the Future of Inclusive Clinical Trials

---

The upcoming year presents an incredible opportunity for advancing diversity and inclusion in clinical trials, reflecting a broader movement toward equitable healthcare solutions. The need for diversity in recruitment strategies is no longer just hopeful; it is quickly becoming an essential framework for ensuring that clinical trial results can be generalized to a global population. As the industry evolves, there is a combined focus on flexible study designs, enhanced representation in clinical staff, and participant engagement strategies adapted to meet the needs of a wider range of participants. The central goals of reforming the research process should be building trust among underserved communities and treating potential participants fairly.¹  

Decentralization is transforming how clinical trials are conducted, breaking down traditional barriers to participation and enabling greater reach across geographic and socio-economic divides. The use of decentralized or hybrid clinical trials has grown significantly, with estimates suggesting that as of 2024, roughly 40% of new clinical trials incorporate decentralized elements. This reflects a clear shift from traditional, site-based trials, particularly in the wake of the COVID-19 pandemic.² By moving beyond centralized trial sites, opportunities can be provided for individuals who might otherwise be excluded.  

Intentionally seeking participants from different backgrounds through decentralization can help clinical trials achieve results that better reflect treatment effectiveness. Inclusivity benefits underrepresented populations, often overlooked in traditional trials, and advances personalized medicine, where treatments are tailored based on genetic, environmental, and lifestyle factors. With decentralized models, supported by emerging technology and communication, trials can meet participants where they are, making participation accessible to all populations.  

The importance of age-appropriate approaches in trials involving children and teenagers is another critical focus that can be addressed by decentralization. Developing communication methods suitable for younger participants, involving parents appropriately, and creating adequate environments ensure that young participants feel included. For patients with disabilities, some steps are essential to improve accessibility, including physical accessibility at trial sites, adaptive communication tools like screen readers that read aloud digital text for participants with visual impairments, and support services. Inclusivity in clinical trials through specialized consent processes and adaptive communication sets a new standard for equity in clinical research.  

The operational advantages of decentralization improves patient convenience while reducing costs and enhancing data collection efficiency.³ 

As we look toward 2025, one of the most significant trends anticipated is the expansion of decentralized, inclusive clinical trials. Even in the face of potential shifts, the year ahead promises not only innovative treatments but also a reimagining of clinical trials that prioritize the needs of all participants, paving the way for a future where research is as diverse and accessible as the populations it serves.  

---

References:

1. Alsan, M., Schpero, W. L., Hochman, M., et al. (2023). Building trustworthy clinical trials through diversity: A policy imperative. The New England Journal of Medicine, 383(874-882). https://doi.org/10.1056/NEJMp2215609  
2. Applied Clinical Trials, FDA Finalizes Decentralized Clinical Trial Guidance, https://www.appliedclinicaltrialsonline.com/view/fda-decentralized-clinical-trial-guidance 
3. Hanley, D. F. Jr, Bernard, G. R., Wilkins, C. H., Selker, H. P., Dwyer, J. P., Dean, J. M., Benjamin, D. K. Jr, Dunsmore, S. E., Waddy, S. P., Wiley, K. L. Jr, Palm, M. E., Mould, W. A., Ford, D. F., Burr, J. S., Huvane, J., Lane, K., Poole, L., Edwards, T. L., Kennedy, N., … Harris, P. A. (2023). Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned. Journal of Clinical and Translational Science, 7(e170). https://doi.org/10.1017/cts.2023.597

Related Insights:

Diversity & Inclusion

FDA’s Path Toward Diversity in Clinical Trials: The DEPICT Act and Sponsor Responsibility

Whitepapers

The DEI Mandate: What’s on the Horizon and What’s Needed for IRB and Recruitment Processes (Part 1 of 2)

Videos

The DEI Mandate: How to Accelerate Diversity Initiatives with Data Analytics and Planning (Part 2 of 2)

Videos