Biopharma Heeding ‘Mission Critical’ Call to Improve Performance of Drug Trials
Responses from 30 participants in a recent roundtable as part of the Tufts Center for the Study of Drug Development (CSDD) Executive Forum indicated that 48 percent of their phase II and III trial sites missed enrollment targets in 2015 and 11 percent failed to recruit a single patient. Fewer than half of patients screened for these trials actually completed them, according to the newly released R&D Management Report from the Tufts CSDD.
The findings were all the more compelling considering that input came from a broad cross-section of stakeholders, including big pharma and biotech companies, contract research organizations (CRO), patient recruitment firms, information technology specialists and representatives from academic investigative sites.
R&D executives have awakened to the bruising reality that improving patient recruitment and retention is “mission critical,” according to Ken Getz, associate professor and director of sponsored research at Tufts CSDD. The need to improve patient enrollment and retention has become even more urgent with the emergence of precision medicine, which requires investigators to recruit volunteers from more narrowly defined and limited subpopulations.
Challenges in managing the efficiency of drug trials also come amid growing pressure from patients, physicians and politicians to accelerate the pace of drug development and to cut the cost of end products.
Biopharmas are experimenting with a variety of approaches, including the use of big data to identify and understand patient populations and of outreach mechanisms such as social media to interact with and engage patients. But the same old problems persist. How do biopharmas connect with patients on a personal level? How do they develop a relationship of trust? And how do they convey the value of participating in clinical trials?
The answers to those questions start with local physicians, Getz said, noting that drug developers must work harder to form collaborative relationships in the community.
Engaging health care providers “is one of the major new frontiers where research needs to go if it hopes to see major improvements in recruitment and retention effectiveness and in the overall speed and efficiency of drug development innovation,” Getz told BioWorld Today. “It’s critical that companies and research centers find ways to partner or to engage the broader health care provider community.”