Reporting preclinical research

NIH Proposed Guidelines for Reporting Preclinical Research Incorporate Endocrine Society Perspective

The potential for basic science to generate new innovations and create positive impacts for society critically depends on the reproducibility of the basic research that informs downstream clinical development and application. In recent years, the biomedical research enterprise has come under criticism from the public and a number of scientists due to the failure of independent laboratories to successfully reproduce a number of prominent, clinically relevant, basic science studies.

In the vast majority of cases, an inability to reproduce major research findings is not due to fraud but rather a diverse set of difficulties that are complicated by the pressures that researchers face in the regular conduct of cutting-edge research. To effectively address these issues the National Institutes of Health (NIH) recognized that other stakeholders, particularly the publishers of academic journals, must be engaged in efforts to ensure that clinical research is based on a robust foundation of reproducible basic research. Therefore, in June of 2014 the NIH, theNature publishing group, and the American Association for the Advancement of Science, held a joint workshop to develop a consensus statement on the reporting of research results. Over 30 editors of major journals were in attendance; Dr. Andrea C. Gore, PhD, Editor in Chief of Endocrinology, participated as a representative of the Endocrine Society.

As a result of the workshop and follow-up communication with journal editors, the NIH recently released a set of “Proposed Principles and Guidelines for Reporting Preclinical Research.” The principles have been endorsed by the representatives of over 70 journals, associations, and scientific societies, including Gore. Endorsing organizations represent journals that publish a broad array of exploratory and hypothesis-testing research. By adhering to the principles, the journals hope to facilitate “the interpretation and repetition in subsequent investigations to establish the robustness of published results across multiple biological systems.” The principles are explained in detail on the NIH website and include the following five themes: 1. Rigorous statistical analysis; 2. Transparency in reporting; 3. Data and material sharing; 4. Consideration of refutations; and 5. Consider establishing best practice guidelines for image based data and descriptions of biological material.

Due to the diligent efforts of the Endocrine Society’s editorial teams and the editors in chief of the Endocrine Society journals the Society has been well ahead of the curve, having already incorporated the principles and guidelines in standard practice. For example, the Endocrine Society established the Endocrinology Antibody Database in 2013, containing information on antibodies that have been validated according to specific requirements established in Endocrinology. Additionally, the Society has demonstrated leadership by establishing the requirement in Endocrinology that articles report the sex of research subjects in preclinical research, and working to broaden this policy to include other Society journals. We are, therefore, encouraged by the proposed principles and look forward to an ongoing discussion with the NIH and other stakeholders about the most effective ways to enhance the reproducibility of basic research.

— Joe Laakso is associate director, Science Policy, for the Endocrine Society. For more information, go to: www.nih.gov/about/reporting-preclinical-research.htm.

National Diabetes Education Program Releases Guiding Principles for Diabetes Care

The National Diabetes Education Program (NDEP), a partnership between the NIH, the Centers for Disease Control & Prevention (CDC), and several organizations and agencies, including the Endocrine Society released a newly published set of 10 guiding principles highlighting areas of agreement for diabetes care that could be clinically useful in diabetes management and prevention. Guiding Principles for the Care of People With or at Risk for Diabetes is aimed at assisting with identification and management of the disease, self-management support for patients, physical activity, and blood glucose control, among other topics.

“There are a lot of diabetes guidelines out there, and practitioners and patients can get confused about which they should follow,” says Judith Fradkin, MD, director of the Division of Diabetes, Endocrinology and Metabolic Diseases in the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH. “With these Guiding Principles, we aren’t creating new guidelines, but clarifying where there is general agreement across myriad diabetes guidelines. Guiding Principles represents a set of sound practices. Our goal in developing this resource is to help clinicians help their patients with diabetes.”