Pharma Companies, Publishers Agree on Publishing Guidelines

Emma Hitt, PhD

May 10, 2012

May 10, 2012 — Pharmaceutical industry and publishing representatives have collaborated to develop 10 recommendations for closing the credibility gap in reporting industry-sponsored clinical research.

Bernadette A. Mansi, from GlaxoSmithKline, led the group of experts from various industry and publishing organizations , including Amgen, Novartis, Johnson & Johnson, Pfizer, the International Society for Medical Publication Professionals, the Journal of Clinical Oncology, the Annals of Internal Medicine, and the Lancet. The report was published in the May issue of the Mayo Clinic Proceedings.

"The credibility of industry-sponsored clinical research has suffered in recent years, undercut by reports of selective or biased disclosure of research results, ghostwriting and guest authorship, and inaccurate or incomplete reporting of potential conflicts of interest," Mansi and colleagues write.

Despite earlier industry efforts to improve publishing standards, "a credibility gap remains: some observers, including some journal editors and academic reviewers, maintain a persistent negative view of industry-sponsored studies," they note.

The current report describes a list of 10 recommendations that are "intended to serve as a call to action for all stakeholders — authors, journal editors, research sponsors, and others — to enhance the quality and transparency of industry-sponsored clinical research reporting."

The recommendations made by the group, as published, are as follows:

  1. Ensure clinical studies and publications address clinically important questions

  2. Make public all results, including negative or unfavorable ones, in a timely fashion, while avoiding redundancy

  3. Improve understanding and disclosure of authors' potential conflicts of interest

  4. Educate authors on how to develop quality manuscripts and meet journal expectations

  5. Improve disclosure of authorship contributions and writing assistance and continue education on best publication practices to end ghostwriting and guest authorship

  6. Report adverse event data more transparently and in a more clinically meaningful manner

  7. Provide access to more complete protocol information

  8. Transparently report statistical methods used in analysis

  9. Ensure authors can access complete study data, know how to do so, and can attest to this

  10. Support the sharing of prior reviews from other journals

"These top 10 recommendations outline several opportunities to enhance the transparency and credibility of industry-sponsored clinical research," Mansi and colleagues write.

According to the authors, sponsors should promote best practice guidelines and work with others to ensure their uniform adoption as well as their dissemination. Likewise, editors must also strive to promote best practices and ensure their policies are "clear, transparent, well publicized, and uniformly applied."

They continue, "[A]ll parties should take the opportunity to extend these efforts toward raising the standards for all research activities, irrespective of industry sponsorship. Such efforts are vital to closing the credibility gap in reporting industry-sponsored clinical research."

Joel Lexchin, MD, professor with the School of Health Policy and Management Faculty of Health, York University, Toronto, Ontario, Canada, who was not involved in the collaboration, noted that these 10 recommendations are a "welcome start" to trying to deal with the problem. However, they may not have much of an effect. He pointed out that "they are full of 'should' and 'could,' and that leaves any changes up to the individual organizations that may or may not choose to take action."

Furthermore, some of the recommendations are quite weak, according to Dr. Lexchin. "For instance, the one on ghost authorship could ask journals to impose a publication ban on anyone who is guilty of ghost authorship," he told Medscape Medical News. "The one on data disclosure does not actually require companies to allow authors to have unrestricted access to all data; it merely states that companies should make their policies on data disclosure clear to authors."

"A large number of meta-analyses have looked into the question of whether sponsorship affects the results and conclusions of clinical research, and most have found that research sponsored by pharmaceutical companies is more likely to show positive results than research with any other source of funding," he said.

"This current set of recommendations, in my opinion, will not eliminate this relationship between funding and results. When clinicians read research sponsored by pharmaceutical companies, they need to be aware of this bias and take it into account in applying the results of the research in their clinical work."

The manuscript was developed through the Medical Publishing Insights and Practices initiative, which is currently funded by Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, Merck, Pfizer, and Takeda Pharmaceuticals North America. Several authors are employees of industry. Dr. Lexchin reports no relevant financial conflicts. He is currently on the Management Board of Healthy Skepticism Inc and is the chair of the Health Action International—Europe Association Board.

Mayo Clin Proc. 2012;87:424-429. Full text

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