Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks flexibility and efficiency to address today’s drug development demands. Challenges include managing product pipelines, targeting small and heterogeneous patient populations, meeting rising standards of evidence from payers moving towards value-based reimbursement models, and addressing the rising role of patients in healthcare decision-making.

With the risk involved in drug development growing, trial complexity increasing, and greater scrutiny of the economic value of new treatments, pharma R&D business models are under significant pressure to improve R&D efficiency. The industry is looking for an innovative process. The focus must be on cost containment and value-based developments that allow sponsors to move more treatments to market faster.

The BBCR’s oversight of clinical trials implemented by CROs includes:

 

• Indication Selection and Prioritization (Risk Management)
• Clinical Plan Development
• Study synopsis and protocol (quality by design)
• CRO selection and contract negotiation
• Investigator/site selection
• Medical Monitoring 
• SRC & DSMB charters
• Investigators and sites’ motivation for patients recruitment
• Review of study data ongoing and study closure
• Safety review and SAEs