January 29, 2015
Sponsors and CROs Implementing New Ways to Better Leverage Investigative Site Relationships
BOSTON – Jan. 29, 2015 – Improved investigative site relationship use and effectiveness are top objectives in 2015 for pharmaceutical companies and contract research organizations, according to drug industry R&D executives participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development.
Drug sponsors and contract research partners said specific strategies that are helping to improve clinical trial performance include soliciting more input from investigative sites to guide study planning and execution; incorporating anticipated changes in the site landscape, such as the integration of clinical research into patient care at large health institutions; and establishing new relationship support mechanisms.
“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.”
Compounding the challenge is a principal investigator (PI) landscape that is in flux. According to Getz, persistently high turnover rates among PIs create instability and present an additional challenge for sponsors and CROs. Since 2006, he said, 55% of PIs in Europe, 53% in Asia/Pacific, and 40% in North America have not conducted another clinical trial.
Participants in the Tufts CSDD Executive Forum noted a number of practices, summarized in the January Tufts CSDD R&D Management Report, released today, that are helping to improve clinical trials. Among them:
- Integrating clinical research into larger health systems improves volunteer retention rates and achieves better outcomes relative to screen failures, without affecting quality.
- Soliciting input from clinical research sites on protocol design, providing payments directly to study patients, sharing their development plans, and providing feedback via scorecards that utilize quality metrics can help sponsors and contract research organizations (CROs) mitigate challenges.
- Having a medical monitor available 24/7 to answer questions when patients are at the site, once a trial is running, can help sponsors and CROs ensure strong site performance.
ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
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.
Tufts Center for the Study of Drug Development
Sandra Peters – 617-636-2170
Business Communication Strategies
Peter Lowy – 617-734-9980