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

This article has a correction. Please see:

  1. Neil Lineberry, associate director1 2,
  2. Jesse A Berlin, vice president, global epidemiology3,
  3. Bernadette Mansi, director, publications and disclosure practices4,
  4. Susan Glasser, senior director, scientific and medical publications5,
  5. Michael Berkwits, electronic editor and deputy editor6,
  6. Christian Klem, senior director, global publications and scientific communications, CV/MeT/CKD7,
  7. Ananya Bhattacharya, director, publication policy and education8,
  8. Leslie Citrome, editor in chief9,
  9. Robert Enck, editor in chief10,
  10. John Fletcher, editor in chief11,
  11. Daniel Haller, editor in chief12,
  12. Tai-Tsang Chen, executive director, head of global biometric sciences13,
  13. Christine Laine, editor in chief14
  1. 1Navigant Consulting, Boston, MA, USA
  2. 2Takeda Pharmaceuticals, Cambridge, MA, USA
  3. 3Johnson & Johnson, 1125 Trenton-Harbourton Road, PO Box 200, Mail Stop TE3-15, Titusville, NJ 08560, USA
  4. 4GlaxoSmithKline, Collegeville, PA, USA
  5. 5Janssen Research & Development, Raritan, NJ, USA
  6. 6JAMA and JAMA Network, Philadelphia, PA, USA
  7. 7AstraZeneca, Gaithersburg, MD, USA
  8. 8Bristol-Myers Squibb, Princeton, NJ, USA
  9. 9International Journal of Clinical Practice, Valhalla, NY, USA
  10. 10American Journal of Hospice and Palliative Medicine, Knoxville, TN, USA
  11. 11Canadian Medical Association Journal, Ottawa, ON, Canada
  12. 12Gastrointestinal Cancer Research, Philadelphia, PA, USA
  13. 13Bristol-Myers Squibb, Wallingford, CT, USA
  14. 14Annals of Internal Medicine, Philadelphia, PA, USA
  1. Correspondence to: J A Berlin JBerlin{at}its.jnj.com
  • Accepted 16 September 2016

Medical Publishing Insights & Practices (MPIP)—a partnership among pharmaceutical companies and the International Society for Medical Publication Professionals—aims to identify ways to improve transparency and credibility in publishing the results of industry sponsored research. This article provides guidance from MPIP on clinically relevant and more informative adverse event reporting, previously identified by journal editors as a significant unmet need to improve patient care and increase the credibility of industry sponsored publications. Our recommendations include highlighting adverse events of most relevance to practitioners and their patients, avoiding broad summary statements such as “generally safe” or “well tolerated,” and including more detailed adverse event 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. Although developed for industry sponsored trials, the adoption of our recommendations would enhance adverse event reporting in clinical research publications regardless of the funding source and thereby facilitate clinical decision making.

Summary points

  • Objective reporting of adverse event data within clinical trials publications could provide greater context and clarity for the application of trial results to daily clinical practice

  • Conference and manuscript abstracts should include objective information on the incidence and type of clinically relevant adverse events instead of overly general statements such as “well tolerated”

  • Clinically relevant adverse events should be identified and communicated with clarity around relevant clinical characteristics, such as severity, frequency, and timing, which could be more informative than incidence rates

  • Adverse event reporting should include numerators and denominators for all events; formal statistical analyses should be used selectively, and post hoc analyses should be clearly identified

Balanced reporting of drug adverse events in medical publications provides important context for healthcare practitioners about the benefit-risk profile of drug interventions. In a recent publication, the authors express the relevant concern: “The extent …

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