Efforts by drug developers during the last 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 latest findings of the Tufts Center for the Study of Drug Development (CSDD).
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.
Examples of these new tools and practices cited by Lamberti 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.
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% 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).
Edited by Gary Cramer