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National Institutes of Health: Better data will improve understanding of federal contributions to drug development : report to congressional requesters
National Institutes of Health: Better data will improve understanding of federal contributions to drug development : report to congressional requesters
Why GAO did this study. With a budget of $43 billion in fiscal year 2021, NIH funds multiple R&D activities that contribute to drug development. NIH-funded biomedical R&D generates basic scientific knowledge on biological mechanisms of various diseases, supports clinical trials investigating if drugs are safe and effective, and trains biomedical scientists who go on to work at universities, in government, and industry. Although not all NIH-funded R&D is directly related to drug development, developing drugs and treatments is one of the agency’s strategic goals. GAO was asked to review how NIH-funded biomedical R&D contributes to drug development. This report examines, among other things, (1) NIH funding for basic research, clinical trials, and biomedical workforce training; (2) reporting of information about NIH-funded clinical trials in the public registry ClinicalTrials.gov; and (3) the extent to which NIH support is disclosed in patents arising from research funded by the agency. GAO reviewed relevant laws and agency documents, analyzed clinical trial and patent data, and interviewed NIH officials, grantees, and academic experts. What GAO recommends. GAO is making two recommendations to NIH, including that its guidance clarify that awardees should name NIH and include the NIH award number when disclosing the agency’s support in patent applications. HHS concurred with the recommendations.
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