Major pharmaceutical companies and medical journals have agreed on 10 steps to improve the credibility of industry-sponsored clinical research.
The recommendations, developed by the Medical Publishing Insights and Practices (MPIP) group, are intended to address concerns about hidden conflicts of interest, ghost-writing and cherry-picking of positive data.
Published in the Mayo Clinic Proceedings, the 10 steps aim to improve transparency in the reporting of trial data, experimental and statistical protocols, adverse events and the professional interests of researchers.
The MPIP initiative was developed with input from GSK, Amgen, AstraZeneca and Sanofi, and is supported by six other major pharma companies.
Journals involved in the discussions included the New England Journal of Medicine and The Lancet.
The 10 steps listed are:
1. Ensure clinical studies and publications address clinically important questions.
2. Make public all results, including negative or unfavourable 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 ghost-writing 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.
The authors commented: “Although framed in the context of industry sponsorship, many of these recommendations would enhance the credibility of clinical research publications in general, regardless of the funding source.”