Drug companies and publishers set out 10 steps to enhance credibility of industry sponsored trialsBMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e3767 (Published 28 May 2012) Cite this as: BMJ 2012;344:e3767
A coalition of drug companies and major medical journal publishers has recommended 10 steps to help refurbish the tarnished credibility and enhance the quality and transparency of the reporting of industry sponsored clinical trials. The 10 steps were published in the May issue of the Mayo Clinic Proceedings.1
The Medical Publishing Insights and Practices Initiative (MPIP) was established in 2008 by leading drug companies and medical publishers as an ongoing collaboration (www.mpip-initiative.org). The recommendations grew out of a meeting held in New York in November 2010.
The initiative’s first recommendation is that research should be grounded in the asking and answering of questions of scientific and clinical importance, within the context of regulatory requirements for approval of a drug or device.
“Credibility is compromised when clinical research is intended for marketing purposes rather than advancing scientific and medical knowledge,” the authors wrote. The paper urges sponsors and authors to “enhance transparency and credibility by better explaining . . . the decision-making process underlying the research endeavor.”
While acknowledging the challenge of publishing negative, confirmatory, or inconclusive results, it emphasised that all trial results must be made public to comply with the law in many countries, fulfil ethical obligations to trial participants, and assure that scientific knowledge is as complete as possible.
Authors must disclose potential conflicts of interest, it said. Efforts should be made towards standardising the criteria and formats for reporting those interests and towards creating a centralised, publicly accessible disclosure database.
The report noted the need to educate authors on how to develop good quality manuscripts for publication and pointed towards efforts such as CONSORT (consolidated standards of reporting trials (www.consort-statement.org)) and the initiative’s own toolkit (http://bit.ly/K2UuqY) as possible guidance.
A further recommendation is that “all parties must continue to work toward zero tolerance of ghostwriting and guest authorship” and give full and accurate recognition of those who contributed to the research and the paper.
Consensus needs to be reached on the type and format of adverse events reporting, while weasel words such as “no unexpected adverse events” should be avoided. Papers need to be more candid about the limitations of studies to detect rare adverse events because the number of patients is small or the duration of observation is short.
The authors urged “access to more complete protocol information,” though this remains a point of ongoing discussion. Companies wish to protect intellectual properties and trade secrets, while all parties acknowledge that trial protocols can be living documents that are modified over time and that this has the potential for confusion.
The authors agreed to the need for transparency in statistical methods but also acknowledged this as an area of ongoing discussion.
The recommendation on access of all of a study’s authors to the raw data is a broad statement of intent that will require greater fleshing out.
The concluding recommendation concerns the need for authors of a rejected paper to share reviewers’ comments and the rejected manuscript when resubmitting to another journal. The authors acknowledge a lack of consensus among editors on this issue.
Cite this as: BMJ 2012;344:e3767
The 10 steps are also available at www.mayoclinicproceedings.org/article/S0025-6196%2812%2900298-4/fulltext.