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The CenterWatch Monthly, December 2016

Thursday, December 1, 2016

Payer influence makes inroads in clinical research

There is an emerging trend for sponsor companies to integrate the payer com­munity’s point of view and expecta­tions into clinical development activities, a movement that could improve the chances that a drug will gain market access, drive faster adoption once launched and result in products that better meet patient needs. Payers increasingly demand evidence of a drug’s value, in terms of demonstrating both better clinical and economic benefits, before they will cover a marketed product. As a re­sult, sponsor companies have begun to reach out to public and private payer groups earlier in the drug development process.

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eTMF adoption and integration accelerating

In today’s clinical trials industry, trial master files (TMFs) pose a costly, time-consuming challenge. In September, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) found that 31% of inspections must be extended due to criti­cal and major TMF findings. These findings included study team members being unable to find requested documents, inspectors lacking direct access and the quality of the documentation being called into question. These results are coming two years after the MHRA revised its definition of criti­cal TMF findings upon noting that 35% of inspections required additional days. Each day added to a study, especially in phase III trials, results in significant costs for spon­sors and patients. Clinical trials account for almost 70% of all R&D spending, primarily because of inefficient processes required to work with disconnected systems.

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