MLA, the Cancer Libraries Section of MLA, and the Association of Academic Health Sciences Libraries (AAHSL) enthusiastically support efforts by the National Institutes of Health (NIH) to expand the ClinicalTrials.gov requirements to include all NIH-funded clinical trials. The groups also applaud efforts to expand and clarify the regulations for clinical trials registration and results submission.
The Associations and Cancer Libraries Section have developed comments that support changes outlined in the NIH Proposed Rulemaking for Clinical Trials Registration and Results under the Food and Drug Administration Amendments Act. For example, the rulemaking would expand the reporting requirements to include studies that have been closed due to adverse events, difficulties in research design, and for other reasons. Expanding the requirements to include all NIH clinical trials will have many benefits for users of the ClinicalTrials.gov database who need access to cutting-edge information.
The groups also provided comments in support of the draft NIH Policy on Dissemination of NIH-funded Clinical Trials Information. The draft policy takes steps to enhance the transparency of clinical trial results and provides patients with more information to make health care decisions, including critical information about the safety of products and treatment options. It also provides clinicians with access to results information such as efficacy, adverse effects, and safety.