As clinical trials become more complex, patient recruitment and retention become more difficult. And added complexity in the form of more procedures per protocol lengthens study cycle times, dissuading study volunteers from staying on board until a trial is completed.
This recruitment double-whammy, identified in recent research results from the Tufts Center for the Study of Drug Development (see related story) puts a fine point on the already well-known difficulties in recruiting and retaining clinical trial subjects.
The rise in eligibility criteria used to screen volunteers is another deterrent, says Ken Getz, senior research fellow.
But there's good news, too. "Differences in complexity and execution burden by phase and therapeutic area indicate that pharma and biotech companies can target their efforts to improve protocol design and improve clinical trial operating performance," Getz says.
In addition, a trade organization has defined its mission to tackle recruitment difficulty head-on. The Patient Recruitment Organization (PRO) Steering Committee, a consortium of subject recruitment and retention companies, says it intends to improve its clinical trial services. "We know there is a need to establish benchmarks for industry-wide practice, so we integrated this value into our mission statement," says chair Diana Anderson, president at D. Anderson & Company, in a release.
Both CROs and software makers are reacting to the recruitment challenge. For example, Quintiles in February unveiled its Trial Enrollment Accelerator, which aids researchers in creating and placing recruitment materials. And London-based TrialReach announced a search and referral engine for subject pre-screening.
- here's the Tufts' announcement
- see this article on the PRO steering committee