Biopharma Innovation in Trouble? - Pharmaceutical Executive

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Biopharma Innovation in Trouble?


Pharmaceutical Executive


Streamlined studies

Biopharma R&D productivity also could benefit from a more robust clinical trial infrastructure that uses biomedical data more effectively, says Woodcock, who would like to see more ongoing clinical trials utilizing standardized data and methodologies that can rapidly screen candidate compounds for signs of efficacy. "Let's not reinvent the wheel with every trial," she commented at a July conference on biomedical innovation sponsored by the Brookings Institution. Instead, a "network of data sources" linked by common protocols for data standards could greatly compress the clinical testing process.

The National Institutes of Health (NIH) similarly aims to help reduce the high failure rate of clinical trials through a target validation consortium, starting with pilots for Alzheimer's disease, diabetes, rheumatoid arthritis and schizophrenia, added NIH deputy director Kathy Hudson. And the Patient-Centered Outcomes Research Institute (PCORI) has launched the National Patient-Centered Clinical Research Network to improve the conduct of clinical outcomes research. The program will consist of some 25 research networks formed by research organizations and patient groups, each able to tap into health data for over one million individuals, explained PCORI chief science officer Bryan Luce at the Brookings conference. Luce acknowledged challenges, but predicted the program would provide "a dynamically linked clinical research network" that can test hypotheses and do adaptive studies, Bayesian trials and observational studies.

Pharma post-marketing studies stand to benefit from the networks' data from real-world patients in usual care settings. Although the PCORI networks may not be that useful in conducting randomized trials for investigational medical products, the program could help identify and recruit patients for clinical studies, encourage use of patient-reported outcomes, and indicate to sponsors why certain patients don't respond to treatments. Key issues are how PCORI develops the governance and structure of the research networks and who has access to the data.








Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at
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