FASEB Comments on Clinical Data Proposals

On August 5, the Federation of American Societies for Experimental Biology (FASEB) issued recommendations on two proposals regarding clinical data. FASEB commented on an approach under consideration at the Food and Drug Administration (FDA) to collect healthcare and clinical research information from common participants and a request for information on maintaining the registry and results databank ClinicalTrials.gov from the National Library of Medicine (NLM).

The FDA proposal aims to streamline clinical research by integrating electronic health records and electronic data capture. Although FASEB recognizes the potential benefits of a single system for end-to-end source data capture in clinical settings, the Federation expressed concern about the time and resources required to create such a system in an August 5 letter. Instead, FASEB suggested FDA consider an existing system for data integration such at the Informatics for Integrating Biology and the Bedside platform, which is currently used in more than 100 academic health centers and biotechnology companies to integrate and search data from different sources.

ClinicalTrials.gov has proven to be a valuable public resource for storing and sharing clinical trial data. In submitted comments, FASEB applauded NLM for its commitment to enhance ClinicalTrials.gov and reduce the effort associated with registering clinical trials and submitting summary results. To achieve these goals, FASEB recommended NLM work with investigators to learn the extent of reporting burdens and improve the data submission and access interfaces.

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