Medical Publishing Insights & Practices (MPIP) has announced the publication of its latest recommendations on improving transparency in clinical trial data disclosures in the online issue of The BMJ (doi: 10.1136/bmj.i5078).
Recommendations to Improve Adverse Event Reporting in Clinical Trial Publications: a Joint Pharmaceutical Industry/Journal Editor Perspective is the latest publication from the MPIP collaboration with leading medical journal editors and industry experts. It calls on clinical trial sponsors, authors, and editors to place greater focus on clinically relevant and informative adverse event (AE) reporting, including highlighting AEs of most relevance to practitioners and their patients, avoiding broad summary statements such as “generally safe” or “well-tolerated,” and presenting more detailed AE data (where appropriate) to offer additional clinically important insight.
These recommendations complement the earlier recommendations in the Consolidated Standards of Reporting Trials (CONSORT) Harms Extension, addressing a critical gap identified by editors and authors for more specific guidance regarding clinically meaningful, informative, and transparent reporting of AEs critical for practical application in the clinical setting.
Although developed for industry-sponsored trials, the adoption of these recommendations would enhance AE reporting in clinical research publications regardless of the funding source and would facilitate better clinical decision-making.
Communicating drug AEs in a more transparent and clinically meaningful manner was one of ten key recommendations to improve the credibility of industry-sponsored publications. Industry experts, members of Medical Publishing Insights & Practices (MPIP), and journal editors from several journals came together in 2014 to discuss ways to improve the communication of AE data. This roundtable included editors from American Journal of Hospice and Palliative Medicine, Annals of Internal Medicine, Canadian Medical Association Journal, Gastroenterology, Gastrointestinal Cancer Research, International Journal of Clinical Practice, Journal of the American Medical Association, Neurology, and The New England Journal of Medicine, as well as industry experts and MPIP members from Amgen, Astellas, AstraZeneca, Biogen, Bristol-Myers Squibb, GlaxoSmithKline, ISMPP, Janssen Research & Development LLC, Johnson & Johnson, Merck, Pfizer, and Takeda.
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