How to minimize low enrolling sites: a case study in diabetes

Area of Science:

• Clinical research
• Pharmacoeconomics
• Health services research

Background:

• India is emerging as a significant global hub for clinical trial conduct.
• Indian clinical trial sites demonstrate a higher subject recruitment rate compared to the global average.
• There is a need to optimize recruitment performance by analyzing site-specific factors.

Purpose of the Study:

• To identify attributes associated with high-performing Indian clinical trial sites.
• To develop strategies for improving patient recruitment processes in India.
• To provide actionable insights for Clinical Research Associates (CRAs) to enhance site performance.

Main Methods:

• Case study analysis comparing high and low performing Indian clinical trial sites.
• Utilizing clinical trial data and insights to identify performance drivers.
• Developing a framework for site selection and patient recruitment enhancement.

Main Results:

• Indian sites generally exhibit superior subject recruitment rates.
• Key attributes influencing performance include PI/study team availability and interest, historical study data, and competitor analysis.
• A proactive approach by CRAs, including site-specific recruitment plans and strong CRA-Investigator relationships, is crucial.

Conclusions:

• Analyzing site performance trends can differentiate high and low recruiting sites.
• Effective CRA support, including proactive issue resolution and motivational strategies, is vital for meeting recruitment targets.
• Optimizing the CRA-Investigator relationship is critical for achieving high recruitment performance in Indian clinical trials.