Tufts Forum Examines Investigative Site Relationships

Improved investigative site relationships and effectiveness are top objectives in 2015 for pharma companies and CROs, according to industry R&D executives participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.
 
Sponsors and CROs said soliciting more input from investigative sites to guide study planning and execution are helping to improve clinical trial performance. Also, incorporating anticipated changes in the site landscape, such integration of clinical research into patient care at large health institutions, and establishing new relationship support mechanisms, were helpful.
 
“There is tremendous pressure on drug development companies worldwide to improve clinical trial performance and efficiency,” said Ken Getz, associate professor and director of sponsored research at Tufts CSDD. “The investigative site landscape represents a major opportunity given that it has been highly fragmented, with wide variation in experience levels, and unable to achieve scale operating efficiencies during the past several decades.”
 
However, challenges lie in the principal investigator (PI) landscape, and according to Mr. Getz, persistently high turnover rates among PIs create instability and present an additional challenge for sponsors and CROs. Since 2006, 55% of PIs in Europe, 53% in Asia/Pacific, and 40% in North America have not conducted another clinical trial, according to Mr. Mr. Getz.
 
Participants in the Tufts forum noted several practices that are helping to improve clinical trials, including: integrating clinical research into larger health systems improves volunteer retention rates with better outcomes relative to screen failures; soliciting input from clinical research sites on protocol design, providing payments directly to study patients, sharing development plans, and providing feedback via scorecards using quality metrics.
 
Additionally, participants noted that having a medical monitor available 24/7 to answer patient questions can help sponsors and CROs ensure strong site performance.