Regulatory Authorities and Requests for Unblinded DMC Data and Reports
This article was originally published in SRA
Executive Summary
There has been an increase in requests from regulatory authorities for unblinded DMC data and reports. Mats Ericson, Shamim Ruff, Alan Morrison, James Matcham and Steve Snapinn examine the issues and argue that such requests should as a matter of principle be challenged and preferably denied.
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