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Stock Watch: A Word To Those Considering Unwrapping Clinical Trials Early

The Perils Of The Interim Review

 
• By Andy Smith

Halfway through a race, adding more athletes, taking out some hurdles and extending the distance until the finish would be unsporting in track and field. But not in clinical trials.

Stock Watch Image, Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

When I worked in one of the world’s biggest CROs, its strict data security and trial integrity policies were all part of the on-boarding process even for those of us working in the drug pricing and market access consultancy. These were echoed by the interactions I had with clinical operations, regulatory and statistical teams. However, a number of company announcements have made me wonder whether every drug sponsor is as stringent.

There are legitimate mechanisms for in-progress trial monitoring that do not divert the usual flow of information from investigators to CRO and finally to the drug sponsor while maintaining clinical...

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