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November 25, 2009

Improving Access to FDA Reviews and Documents

JAMA. 2009;302(20):2204-2205. doi:10.1001/jama.2009.1727

To the Editor: We support the call by Dr O’Connor1 for greater availability of data generated in clinical trials that may not have been viewed as favorable so that complete systematic reviews can be done. However, increased access to FDA reviews will not solve the larger issue of trial data transparency. This must be resolved by all parties involved in the generation and publication of clinical data (investigators, academia, industry sponsors, journal editors, regulators).