Maintaining the trust of physicians and the public in the medical literature: report of a task force on scientific publishing of clinical trials

Abstract

In 2006, the American Society of Bone and Mineral Research and the Journal of Bone and Mineral Research convened a task force to consider whether and how to change our editorial policies to assure complete and unbiased reporting of clinical trials. We invited editors of journals that publish research on osteoporosis and disorders of bone and mineral metabolism and presidents of related societies to participate. The task force was charged to consider whether journals should (1) adopt the Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials published in 2006 by the American Association of Medical Colleges (AAMC) and should (2) require authors and sponsors of industry-funded clinical trials to provide a jointly signed letter that states that the authors had full access to all the data and analyses on which the manuscript was based. The AAMC Principles recommend that multicenter trials should designate a Lead Investigator, Steering Committee, and Publication and Analysis (P&A) Committee, which should consist of a majority of academic investigators who are not sponsor employees. The P&A Committee should have the right to access any data generated during a study and to conduct its own statistical analyses. A majority of task force members voted to support the AAMC Principles, to require a letter jointly signed by academic investigators and industry sponsor stating that the authors had access to the data on which the submission was based, and to recommend adoption of these requirements to their respective societies and journals. Broad-based adoption of the AAMC Principles and requirement of a jointly signed attestation of data access by journals that publish clinical trials in diseases of bone and mineral metabolism should improve the position of academic clinical investigators in their interactions with industry and other funding sources.