New research characterises effectiveness and variability in patient recruitment and retention practices
A recent analysis aimed to help clinical research professionals better plan and manage clinical trials
- Date: 23 Apr 2013
- Topic: Bioethics, legal and economic issues
Although the managers of nine out of 10 clinical trials worldwide meet their patient enrolment goals, reaching those targets typically means that drug developers need to nearly double their original timelines, according to new research from the Tufts Center for the Study of Drug Development (CSDD) that benchmarks patient recruitment and retention practices.
A recent analysis by the centre, based on more than 150 clinical studies involving nearly 16,000 sites, aimed to help clinical research professionals better plan and manage clinical trials.
According to Ken Getz, director of sponsored research at Tufts CSDD, patient recruitment and retention are among the greatest challenges that the clinical research enterprise faces today, and they are a major cause of drug development delays. The results of this recent study paint a complex picture of global practices and their effectiveness and characterise a very high level of investigative site performance risk.
The study found that most drug sponsors and contract research organisations rely on a limited number of traditional recruitment and retention tactics, such as physician referrals and newspaper, television, and radio ads, and have yet to embrace non-traditional approaches, including social media.
The study, reported in the January/February Tufts CSDD Impact Report, also found that:
- 89% of all clinical trials meet enrolment goals, with site activation rates reflecting success with study start up and speed to recruit the first patients.
- The highest site activation rates are in Western Europe (93%), Eastern Europe (92%), and Asia/Pacific (91%).
- Enrolment achievement rates vary by region, ranging from 75% to 98% of targeted levels, with Asia/Pacific and Latin America achieving the highest rates.
- 11% of sites in a given trial typically fail to enrol a single patient, 37% under-enrol, 39% meet their enrolment targets, and 13% exceed their targets.
The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.