The Duke-Robert J. Margolis Center for Health Policy http://healthpolicy.duke.edu recently published three white papers focusing on improve the tools and methods that underpin the development of innovative drugs to treat a variety of diseases and condition. The White Papers were developed under a cooperative agreement with FDA and in conjunction with expert working groups.
One of the three White Paper is titled ‘Facilitating Biomarker Development: Strategies for Scientific Communication, Pathway Prioritization, Data-Sharing, and Stakeholder Collaboration.”
One section in the White Paper discusses some of the cultural barriers to collaborative data sharing. Despite awareness of the benefits of data sharing, stakeholders are prevented from readily sharing and pooling their data and resources.
Industry academia, and regulators, produce and store vast amounts of data that could potentially accelerate biomarker development if shared. It was found that targeted incentives and enforcement mechanisms are needed to overcome barriers to data sharing for each stakeholder group and to encourage more team-based or collaborative approaches to scientific research.
Representatives from industry indicate that requests for access to data has been limited, suggesting that greater communication is needed between researchers and sponsors to identify opportunities for future research.
Increasing data requirements for biomarker development and sustainability is a major challenge for all stakeholders. Therefore, greater resources and investments are needed to support rigorous data collection practices and infrastructure.
There is a lack not only financial resources for data management but also to hire qualified personnel. It has been suggested that some grant resources should be dedicated specifically to support data management.
The authors of the White Paper include Gregory W. Daniel, Deputy Director, for the Duke Robert J. Margolis MD Center for Health Policy, Elizabeth Richardson, Research Associate for the Center, Mark B. McClellan, Director of the Center along with Waseem Nosair, Research Assistant for the Center.
The other two White Papers are titled “Improving Productivity in Pharmaceutical Research and Development: The role of Clinical Pharmacology” and “Pioneering Statistical Approaches to Accelerate Drug Development through Adaptive Trial Designs.