Impact Story • Success Story
Advancing Clinical Trial Design and Implementation in Resource-Limited Settings
By Tejaswini Manjunath(1), et al.
All Authors and Affiliations
Affiliations:
1. Digital Infuzion
Posted April 24, 2026
Featured CTSA Institutions:
Mayo Clinic Rochester
UT Southwestern Medical Center
University of North Carolina at Chapel Hill
University of Pennsylvania
University of Southern California
Yale University
Abstract
FDA approval of new medications and treatments requires that the benefits of those interventions be demonstrated in clinical trials. Yet many trials fail due to inadequate numbers of patients enrolled or inefficiencies in trial design. Sometimes trials are completed, but the benefits are never fully realized because they are not practical to implement under real-world conditions. CTSA-funded research into addressing these issues has had a broad impact since 2008. The five featured research publications have identified multiple barriers to recruitment of volunteers and strategies to improve trial feasibility and recruitment. Factors have been identified that led to low enrollment, causing clinical trials to terminate early, so that these can be avoided in the future. Research has also addressed the challenges of conducting trials in resource-limited communities and provided recommendations for adapting recruitment strategies. The global distribution of benefits from clinical trials has also been examined and highlights the importance of sharing benefits worldwide.
13
Cited in clinical trials
23
Cited by healthcare policies
3
Cited in patents
Impact Story
Clinical trials are essential for developing new therapies and advancing medical knowledge since they produce the evidence for successful patient treatments. However, many trials face challenges such as complex study designs, restrictive eligibility criteria, and limited participation from underserved populations. These issues can slow enrollment, reduce the usefulness of results, and limit the benefits for patients, especially in resource-limited settings. Since 2008, Clinical and Translational Science Awards (CTSA) research has contributed important work to improve how trials are designed and conducted, and to make them more broadly applicable to patients.
Five key publications highlighted here were selected for their role in identifying barriers to successful clinical trial completion and their contribution to new medical policy, demonstrating the impact of CTSA-supported research over time.
CTSA-supported investigators have helped strengthen the methodological foundations of clinical trial design. The study Design and Endpoints of Clinical Trials in Hepatocellular Carcinoma (Llovet et al., 2008) provided widely adopted guidance on selecting appropriate measurements of outcomes and the right patient populations for liver cancer trials. By recommending standardized measures such as time-to-progression and overall survival, the work improved the consistency and comparability of clinical studies and has been cited in 18 policy documents, three patents, and 12 clinical trials, reflecting its influence on more successful clinical trial practices.
Research has also highlighted how trial eligibility criteria can unintentionally limit which patients can volunteer to participate. A study examining thoracic oncology trials (Garcia et al., 2017), which has been cited in two policy documents, found that eligibility requirements have become increasingly complex over time. While these criteria are intended to protect patient safety and ensure rigorous study results, excessive requirements can restrict enrollment and reduce how well trial findings apply to real-world patient populations.
CTSA-supported studies have also examined operational barriers that affect the recruitment of patients. Analysis of a multi-site randomized clinical trial that closed early due to low enrollment (Peters-Lawrence et al., 2012) identified several factors that hindered participation, including complex protocols, limited staffing, and competing clinical studies and has been cited in a policy document. Understanding these barriers has helped researchers develop strategies to improve trial feasibility and participant recruitment.
In addition, CTSA-supported research has addressed the challenges of conducting trials in resource-limited areas. A study examining intervention research in disadvantaged communities (Pyatak et al., 2013) identified barriers such as unstable living conditions, transportation limitations, and competing daily needs that can affect participation in clinical research. The study provided recommendations for adapting recruitment strategies and trial protocols to better support broad inclusion and has been cited in one policy and one clinical trial.
Finally, CTSA-supported research has examined the global distribution of benefits from clinical research trials. A cross-national analysis of trials supporting U.S. Food and Drug Administration drug approvals (Miller et al., 2021), cited in one policy document, found that many trials enroll participants from middle- and lower-income countries, yet new therapies often become available much later—or not at all—in those same regions. These findings highlight the importance of policies that ensure the benefits of clinical research are shared worldwide.
Together, these CTSA-supported studies demonstrate how improving trial design, simplifying eligibility criteria, addressing recruitment barriers, and promoting participation can strengthen the clinical research enterprise and ensure that new therapies benefit more patients in a greater variety of clinical and resource settings.
