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Research Methods & Reporting

Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective

BMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i5078 (Published 03 October 2016) Cite this as: BMJ 2016;355:i5078

Rapid Response:

Re: Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective

Response to Dr. Matheson:

We thank Dr. Matheson for acknowledging the worthwhile goals of our publication and the “probity of everyone involved in the project, their careful thinking and commitment to improving journal publications,” and for stating that he has “every confidence in the integrity of the authors.” Indeed, all authors participated in developing the recommendations, vetted the examples to illustrate them, fulfilled ICMJE criteria for authorship, and submitted conflict of interest disclosures per journal requirements. Our objective was to provide a guide to more clinically relevant and informative adverse event reporting. We welcome feedback from those skilled in clinical trial design and hope that our recommendations trigger a heightened interest in reporting adverse events in a clinically meaningful manner.

Medical Publishing Insights & Practices (MPIP) was founded in 2008 by medical publication professionals in the pharmaceutical industry and members of the International Society for Medical Publication Professionals (ISMPP) to elevate trust in and the transparency and integrity of published results of industry-sponsored research. The major goal of MPIP is to encourage more effective partnerships between trial sponsors and medical journals to raise standards in medical publications and expand access to research results. For a detailed description of MPIP objectives, funding and resources, please see the MPIP website: https://www.mpip-initiative.org/about.html.

Competing interests: JAB, AB, TC, SG, CK, NL, and BM are employees of companies sponsoring MPIP, as shown by their individual affiliations. As well as the reported links with MPIP, BM is a shareholder at GlaxoSmithKline, and serves as chair of MPIP; SG owns stock and stock options in Johnson and Johnson Common Stock; MB reports salary support from the American Medical Association, outside the submitted work; CK held stocks in AstraZeneca; CL is employed by the American College of Physicians as editor in chief of Annals of Internal Medicine, a medical journal that publishes clinical trials; and LC has received consulting or speaking fees outside the submitted work from Acadia, Alexza, Alkermes, Allergan, AstraZeneca, Avanir, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Forum, Genentech, Janssen, Jazz, Lundbeck, Merck, Medivation, Mylan, Neurocrine, Novartis, Noven, Otsuka, Pfizer, Reckitt Benckiser, Reviva, Shire, Sunovion, Takeda, Teva, Valeant, and Vanda, and has stock ownership in Bristol-Myers Squibb, Eli Lilly, J and J, Merck, and Pfizer.

17 March 2017
Jesse A. Berlin
Vice President, Global Epidemiology
Neil Lineberry, Bernadette Mansi, Susan Glasser, Michael Berkwits, Christian Klem, Ananya Bhattacharya, Leslie Citrome, Robert Enck, John Fletcher, Daniel Haller, Tai-Tsang Chen, Christine Laine
Johnson & Johnson
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