January 15, 2013
New Research from Tufts [CSDD] Characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices
BOSTON — Jan. 15, 2013 — While nine out of 10 clinical trials worldwide meet their patient enrollment 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, benchmarking patient recruitment and retention practices.
Tufts CSDD said its recent analysis, based on more than 150 clinical studies involving nearly 16,000 sites, will help clinical research professionals better plan and manage clinical trials.
"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," said Ken Getz, director of sponsored research at Tufts CSDD. "The results of our recent study paint a complex picture of global practices and their effectiveness and characterize a very high level of investigative site performance risk."
The Tufts CSDD study found that most drugs sponsors and contract research organizations 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, released today, also found that:
*89% of all clinical trials meet enrollment goals, with site activation rates reflecting success with study startup and speed to recruit the first patients.
*The highest site activation rates are in Western Europe (93%), Eastern Europe (92%), and Asia/Pacific (91%).
*Enrollment 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 enroll a single patient, 37% under-enroll, 39% meet their enrollment targets, and 13% exceed their targets.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) 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.
Contacts: Tufts Center for the Study of Drug Development
Sandra Peters — 617-636-2185