In a bid to become more transparent, the Food and Drug Administration is launching a program to determine the benefits of disclosing certain summaries of clinical trial data, a notion that has evoked long-standing debate over patient privacy, trade secrets, and improving medical research.

The program will release so-called clinical study reports, which contain summary information and analysis, from up to nine different applications filed by companies that seek to market new prescription drugs. The agency plans to rely on drug makers to volunteer to participate.

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  • The only advantage this would provide is to competitors to give them a nice roadmap. It’s a copycat industry. When I started developing a new drug the first thing I requested was the SBA, or summary basis of approval. Now all you have to do is google Drugs at FDA, look up the drug of interest and you will find the complete medical review, usually within 30 days of approval. Single study reports may misleading. If you want some meat before approval make available the ISE (Integrated Summary of Efficacy) and the ISS (Integrated Summary of Safety), which have to be completed by the drug company before the NDA is submitted.

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