(PRWEB) October 05, 2016
Beachwood, OH: Medical Publishing Insights & Practices (MPIP) today 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.
The publication’s main recommendations for AE reporting from clinical trials include
Recommendation 1 – Identify and communicate the most clinically relevant drug adverse event data as part of a comprehensive safety profile
- Although “clinical relevance” varies from one disease setting to another, it generally includes AEs that affect treatment tolerability and adherence, require upfront monitoring or early intervention, or have serious and long-lasting consequences
Recommendation 2 – Report timing, frequency, duration, and other potentially relevant descriptors when clinically appropriate
- Include such descriptors (for example, the severity of an AE and whether it led to treatment discontinuation) whenever feasible, as these could be more informative and clinically useful than incidence rates alone
Recommendation 3 – Use statistical analysis for clinically relevant adverse events (where appropriate)
- AE reporting should include numerators and denominators for all events; formal statistical analyses should be used selectively, and post hoc analyses should be clearly identified
Recommendation 4 – Avoid use of overly general text descriptions for adverse events, including in abstracts
- Use of overly general terminology is not informative and raises questions about credibility and transparency of publications. Summary statements should be supported with specific and informative data, which is interpreted in the context of the trial design and its limitations
Recommendation 5 – Discuss adverse events findings in the broader context of available evidence and maintain consistency of data across different public reports
- Look beyond the individual publication at hand and understand how the individual trial results relate to the larger body of clinical evidence. Also, multiple reports from the same study should be presented consistently
"A clear understanding of both the beneficial and adverse effects of medical interventions is critical to clinical decision-making. Unfortunately, the reporting of adverse events in clinical trial reports often falls short of the type of information clinicians and patients need. The MPIP recommendations on adverse event reporting in clinical trials provide practical guidance to supplement existing reporting recommendations. Following this guidance promises to substantially improve the usefulness of clinical trial reports,” says Christine Laine, MD, MPH, Editor in Chief, Annals of Internal Medicine.
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.
About MPIP: Medical Publishing Insights & Practices (MPIP) was founded by members of the pharmaceutical industry and the International Society for Medical Publication Professionals (ISMPP) to elevate trust, transparency, and integrity in publishing industry-sponsored research. Current corporate co-sponsors include Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Research & Development LLC, Merck, Pfizer, and Takeda.
You may also access these links for additional information:
1. Ioannidis J, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781-788. doi: 10.7326/0003-4819-141-10-200411160-00009.
2. Mansi BA, Clark J, David FS, et al. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clinic Proc. 2012 87(5);424-429. doi: 10.1016/j.mayocp.2012.02.009.