While many drug developers continue to improve clinical trial operational efficiency to increase the pace of new product introductions, their medium- and long-term success increasingly will depend on their ability to embrace more efficient R&D models, according to a new report released by the Tufts Center for the Study of Drug Development.
“Pharmaceutical and biotech companies-large and small, established and early stage-are forging strategic alliances, collaborative partnerships, and multi-company consortia,” said Tufts CSDD Director Kenneth I Kaitin. “Early results indicate that sharing knowledge and leveraging resources is helping sponsors find new drugs to treat many of today’s most challenging and complex indications.”
Noting that the drug development model has not fundamentally changed in more than 50 years, when the Kefauver-Harris Amendments of 1962 established the current standard for the clinical testing of investigational drugs, Kaitin said, “Perhaps the greatest gain from clinical design improvements and new partnership models will be the development of industry best practices, which will enable companies to maximize their formidable R&D investment and help ensure future commercial success.”
The report further notes that:
- Growing concern over expensive, late-stage clinical development failures will lead firms to reassess their use of meta-analyses and subgroup analysis and make more realistic assessments about the likelihood of candidate success.
- Adoption of adaptive clinical trial designs will accelerate, particularly in earlier clinical phases, as cross-functional teams within sponsor companies look to increase program success rates while lowering costs and disruptions from protocol amendments.
- The U.S. Food and Drug Administration will foster greater use of patient-reported outcomes to support labeling claims in drug applications and make greater use of social media and the Internet to communicate with patients, caregivers, and patient advocates.