Publication of Industry-Sponsored Medical Research: Guidelines from the Consortium of Laboratory Medicine Journal Editors

R ecently, the editors of nine leading laboratory medicine journals created the Consortium of Laboratory Medicine Journals Editors (CLMJE) to “complement the efforts of the World Association of Medical Editors and the Committee on Publication Ethics by issuing guidelines and requirements that are specific to laboratory medicine issues” (1). Earlier this year the CLMJE issued a statement regarding the need for full disclosure for industry-sponsored laboratory research publications. The statement was simultaneously published in the journals served by the editors who created CLMJE: Clinical Chemistry, Clinical Chemistry and Laboratory Medicine, Clinica Chimica Acta, American Journal of Hematology, Clinical Biochemistry, Transfusion, American Journal of Clinical Pathology, and Scandinavian Journal of Clinical and Laboratory Investigation. The statement indicated that the journals in which the statement was published would “require compliance with these guidelines for publication” (1). These guidelines were developed to identify author conflict of interest and their role in the study and to ensure disclosure of manufacturer-specific information on laboratory instruments and assays.

Any prospective authors are now required to indicate and describe the role of their respective sponsoring organizations that supported the preparation of the study, the analysis of the data, and the preparation of the manuscript. Authors may also be required to disclose all personal, financial, and other relationships they may have with the manufacturer of any product mentioned in the manuscript or with the manufacturers of competing products. Most importantly, the guidelines indicate that full disclosure is required in comparison and in standardization studies linking the name of a manufacturer of an analytic test or instrument with the data obtained and reported in the manuscript. The consortium requirements are similar to those of the International Committee of Medical Journal Editors that has policies requiring full disclosure of all potential conflicts of interest at manuscript submission.

Partnerships between industry and investigators to support research can be beneficial to both parties, especially with the declining government and noncommercial sources of research funding. The funds necessary to develop and study laboratory assays are significant and essential to effectively use these to assess and monitor disease for the benefit of many patients (2). Funding by industry is a valid funding source for these studies, although this relationship has the potential to generate bias that must be identified. The purpose of the CLMJE consortium is to promote the full disclosure by the authors and complete transparency in the data to assure the integrity of the published reports and to prevent undesirable practices. The members of the consortium have encouraged other journal editors who publish scientific studies funded by industry to adopt these guidelines.

The American Thyroid Association Board of Directors and Lab Services Committee endorse this consortium recommendation to identify conflicts in industry-supported laboratory testing studies and to provide specific information on laboratory assay and instrument manufacturers that will provide useful information to clinicians. We have been informed by Charles H. Emerson, M.D., Editor-in-Chief of Thyroid, that Thyroid endorses the principles of the CLMJE statement and is considering their incorporation into Thyroid's Instructions for Authors.