October 8, 2013
Drug Sponsors & Their External Service Partners Say Adjusting Relationship Models Offers a Path to Greater Performance...
BOSTON – Oct. 8, 2013 – While drug sponsor use of strategic relationships with contract service providers has increased dramatically during the past five years, improvements in clinical trial efficiency has fallen short, suggesting that both parties need to better align practices, processes, and systems, according to leaders from the research-based drug industry, recently convened by the Tufts Center for the Study of Drug Development to discuss the issue.
“Sponsors and CROs have a strong interest in improving clinical trial efficiency and performance, but organizational culture, practice, and incentives are getting in the way of optimizing collaborative impact. For example, many clinical operations within drug companies still focus on cost savings and practices designed to manage commodity-service providers,” said Ken Getz, associate professor and director of sponsored research at Tufts CSDD.
He noted: “Roundtable participants agreed that actively aligning organizational goals, expectations, and incentives will go a long way to improving operating efficiency by better leveraging the capabilities, expertise, and innovative ideas that contract providers can bring to the table.”
Among factors pressing on sponsors and CROs to improve the launch rate of new drugs, and at lower cost, is anticipated growth of personalized medicine that targets specific, but narrower, patient populations, which can limit financial opportunities.
Among other points made by industry leaders, summarized in the October Tufts CSDD R&D Management Report, released today:
Sponsors who take a more proactive approach to relationship quality management, compared to those who are more reactive, attain greater levels of satisfaction with the work of their CRO partners.
Both parties recognize the need to move from a risk-averse to a value-creation orientation, but acknowledge that it requires a mindset that says, “We are all colleagues and collaborators.”
Further productivity gains will flow from sponsors engaging CROs in protocol design to reduce the need for amendments and greater use of big-data capabilities to manage and assess clinical trial data in real-time.
SCHEDULED TUFTS CSDD EXECUTIVE FORUM ROUNDTABLES
Upcoming Tufts CSDD Executive Forum Roundtable meetings:
Nov. 7, 2013: Enhancing Product Value through Comparator and Co-Therapy Clinical Trials
Feb. 20, 2014: Predictors of Clinical Success: New Approaches to Boosting Success Rates
ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
The Tufts Center for the Study of Drug Development 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.