Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Posted in FDA Regulatory Affairs, Health Law & Patient Safety, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Technology Transfer: Biotech and Pharmaceutical | 2 Comments

2 Responses

1. on September 29, 2012 at 8:20 PM | Reply sjwilliamspa

   This is an excellent presentation concerning a very troublesome topic. The pressure to publish in the academic setting and pressure for drug approval in the industrial setting may lead one to believe there is a preponderance for misrepresentation however the lack of reporting of negative data can be just as much misconduct as falsifying data. As many of us have reviewed papers (some clinical) the peer review system is hampered by the fact that reviewers can only judge on what is presented to them. This is an unfortunate reality of the current system. Currently I see companies now expanding their pharmacovigilence departments however these departments seem to be focused on approved drugs and not drugs currently in trials. Hopefully kpharmacovigilence will become a more proactive endeavor in these companies.

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2. on September 29, 2012 at 8:58 PM | Reply 2012pharmaceutical

   We are on the same page on this topic.

   Thank you for the comment.

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