Tag: Clinical Trials

The NCATS Trial Innovation Network – A Resource Supporting High Quality and Cost Effective Clinical Trials Available to You

July 3, 2018
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Well-conducted randomized trials are considered the best method of providing evidence about the safety and efficacy of treatments to improve health. Each year, NIH Institutes and Centers spend an estimated $3-4 billion supporting clinical trial activities. These activities require high-level understanding of human biology, of manufacturing and pre-clinical research, and of regulatory requirements. The process of translating a new therapeutic from discovery to practice can be robust, but … at the same time is long and expensive – and despite the challenges inherent in complex, multi-disciplinary research sometimes too long and too expensive.

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NIH Announces Inclusion Across the Lifespan Policy

January 24, 2018
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Last month, NIH announced a revision (NOT-OD-18-116) to a decades-old policy originally conceived in response to concerns that children were not appropriately included in clinical research. These changes broaden the policy to address inclusion of research participants of all ages, and as discussed at the last Advisory Committee to the NIH Director meeting, will apply beginning in 2019 to all NIH-supported research involving human subjects. Our goal is to ensure that the knowledge gained from NIH-funded research is applicable to all those affected by the conditions under study.

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Continuing to Strengthen Inclusion Reporting on NIH-funded Phase III Trials

January 8, 2018
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Much has been learned about how sex and race may contribute to differences in health outcomes and physiologic conditions (Clayton, 2014). We know that, for example, a specific drug used to treat insomnia requires different dosing for women and men. African Americans with hypertension are more susceptible to stroke than whites with the same blood pressure levels (Howard, 2013). But in many cases, findings from potentially informative stratified analyses may not be widely available. Less than a third of NIH studies required to analyze sex/gender and race/ethnicity have been found to publish sex-stratified results in peer-reviewed journals (Foulkes, 2011).

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Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Questions

January 4, 2018
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In August and September we released case studies and FAQs to help those of you doing human subjects research to determine whether your research study meets the NIH definition of a clinical trial. Correctly making this determination is important to ensure you are following the initiatives we have been implementing to improve the transparency of clinical trials, including the need to pick clinical trial -specific funding opportunity announcements for due dates of January 25, 2018 and beyond.

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Implementing a New Human Subject and Clinical Trial Information Form

October 11, 2017
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We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.

The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms ….

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