BMJ  2005;330:959 (23 April), doi:10.1136/bmj.330.7497.959

Commentary

Why industry should register and disclose results of clinical studies—perspective of a recovering academic

Jesse A Berlin, senior director, statistical science1

1 Johnson & Johnson Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Road, PO Box 200, Titusville, NJ 08560, USA jberlin@prdus.jnj.com

The first 150 words of the full text of this article appear below.

Although it's not typical, in a scholarly publication such as the BMJ, to add a personal perspective to a commentary, I believe that in this situation my background is relevant to the discussion. My doctoral dissertation, written in 1988, dealt with the topic of publication bias, which was well described in the Ottawa statement appearing in this issue.1 Since then, I've contributed to several studies of factors affecting publication, including an early empirical demonstration of publication bias.2

About six months ago, I moved from a university, where I had spent 15 years, to a position in a large pharmaceutical research and development group. Registration and disclosure of the results of clinical studies have, not surprisingly, been topics of numerous conversations where I work.

At this point, as suggested in the Ottawa statement, there is no longer any doubt that studies, whether sponsored by pharmaceutical companies or otherwise, will be . . . [Full text of this article]


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Relevant Article

Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
Karmela Krleza-Jeric, An-Wen Chan, Kay Dickersin, Ida Sim, Jeremy Grimshaw, Christian Gluud for the Ottawa Group
BMJ 2005 330: 956-958. [Extract] [Full Text] [PDF]

Rapid Responses:

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past trials
benjamin dean
bmj.com, 25 Apr 2005 [Full text]
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