Drug Developers Are Making Strides in Streamlining Patient Recruitment & Retention for Clinical Trials
Efforts by drug developers during the past decade to improve recruitment and retention of patients for clinical trials appear to be paying off, as enrollment timelines are now equal to or shorter-than-planned timelines in 77% of studies, according to a new study from the Tufts Center for the Study of Drug Development that updated global industry benchmarks for patient recruitment and retention.
A previous Tufts CSDD study completed in 2012 found that a high percentage of clinical trials had to extend planned timelines to achieve target enrollment, and nearly half of the studies (48%) took significantly longer to meet their timelines.
“The industry has responded to pressures to streamline drug development and has adopted various approaches, including implementing new tools and practices to optimize patient recruitment and retention effectiveness,” said Mary Jo Lamberti, Research Assistant Professor and Associate Director of Sponsored Research at Tufts CSDD, who led the study. “Some of these include soliciting patient input to optimize protocol design feasibility, increased use of technology solutions and mobile apps, and patient-engagement models designed to lessen the burden of patient participation.”
Despite the improvements, clinical trial recruitment efficiency varies across the globe, the study found. For example, Asia/Pacific and North America had the highest mean activation rates in Phase 2, 2/3, and 3 clinical trials—exceeding 85%—compared to Eastern and Western Europe, Latin America, and rest of world.
Among other key findings summarized in the January/February Tufts CSDD Impact Report, were the following:
-On average, 85.7% of activated sites enrolled at least one patient in late development studies, compared to 87.0% for early development studies.
-Late development studies had an average drop-out rate of 19.1% in 2019, up from 15.3% in 2012.
-No significant differences were found in the mean number of patients enrolled per site or by therapeutic area in 2019, compared to 2012.
-Average recruitment budget for late development studies was $636,515, and the mean budget per site was $7,726 ($2,273 per patient).
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.
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