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

• Published in: Perspectives in clinical research 2010-01, Vol.1 (1), p.25-28
• Main Authors: Abraham, Abby, Jones, Janet, Vikram, Sunitha
• Format: Article
• Language: English
• Subjects: Case studies; Clinical trials; Diabetes; Feasibility; India; Methods; Patient Recruitment; Research Methodology; Site Performance
• ISSN: 2229-3485; 2229-5488
• DOI: 10.4103/2229-3485.71843

India is becoming one of the fast evolving destinations for conducting global clinical trials. This case study shows that, as expected, Indian sites have a higher subject recruitment rate than the global average there. However, there is scope to enhance subject recruitment performance by looking at the relative performance of the Indian sites. The case study looks at high and low performing Indian sites to define the attributes associated with performance. Clinical trial insight has been used to develop a series of steps to help facilitate in identification of sites and improve patient recruitment process. Tips are provided on how the CRA can review historical and competing study data, the importance of assessing the availability and interest of the PI and study team. With this knowledge, the CRA can pro actively help sites identify and resolve potential issues related to start up delays and recruitment by creating a site specific recruitment plan and lastly encourage and motivate sites to achieve the target as per the agreed plan. The importance of CRA-Investigator relationship is another critical element in achieving high recruitment performance. Analysis of these trends can serve as indicators for site performance and help to differentiate the low from high recruiting sites.