Healthy Skepticism Library item: 19819

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Wagner E, Tumas JA, Field EA, Glazer NB, Schulz G, Grossman L
Letter To The Editor: Good Publication Practice Guidelines For Pharmaceutical Companies
CMAJ 2000 Oct; 14:(9):749

Abstract:

Dear Sir,
Several journals have recently drawn attention to the problems associated with duplicate publication (1) and ghost writing (2,3), and the advantages of registering clinical trials (4). While clinical trial registers address some problems, their efforts on patient care will be limited unless they are backed by sound publication policies. Similarly, while guidelines such as the Consolidation of the standards of reporting trials (CONSORT) statement (5) represent a valuable effort to raise the standards of reporting clinical trials, they do not address related issues such as selective publications or relationships between investigators and sponsoring companies. Most clinicians rely on the published literature for information about clinical trials and are forced to take this information at face value. Selective or poor reporting of clinical trials limits the usefulness of information available to health care practitioners.
For these reasons, we have prepared guidelines for good publication practice for use by pharmaceutical companies when they seek to publish results from their clinical trials. These guidelines cover topics such as preventing duplicate or selective publication, trial identification, companies’ relations with investigators and the use of professional medical writers. Five companies (AstraZeneca, Glaxo Wellcome, Hoescht Marion Roussel, Eli Lilly and Merck) have already endorsed the guidelines, and we are currently contacting another 50 companies to seek their endorsement. We will submit the guidelines for publication once the other companies have had time to decide whether to adopt them. In the meantime, we would like to hear from companies interested in considering the guidelines for endorsement or from others who would like more details of this project.