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. Continue reading
I recently wrote an essay for the NIH’s Science, Health, and Public Trust series to encourage a healthy bit of skepticism about clinical studies that solely involve surrogate end-points (e.g. changes in “biomarkers” like blood cholesterol levels or findings on an electrocardiogram). Continue reading
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. Continue reading
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). Continue reading
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. Continue reading
Recent policy changes requiring clinical trial applications to be submitted to FOAs that specifically allow clinical trials, first announced in fall of 2016, impact how all NIH applicants choose a FOA, whether you are submitting a clinical trial or not. Continue reading
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 …. Continue reading
A few weeks ago we released some case studies and FAQs to help clarify for our research community whether their human subjects research study meets the NIH definition of a clinical trial. These resources prompted a number of follow-on questions and thoughtful suggestions from the community that have helped us refine both the FAQs and the case studies. We are grateful for your thoughtful and constructive comments and suggestions, many of which we have incorporated into our revised documents and communications. …. Continue reading
Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding … Continue reading
In September Dr. Carrie Wolinetz and I blogged about our policy reforms to build a more robust clinical trials enterprise through greater stewardship and transparency at each phase of the clinical trial journey from conception to sharing of results. We discussed how these efforts promise to improve the quality and efficiency of clinical trials, translating into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health.
Over the past months we have continued to partner with the community to work through the implementation of these new policies, developing responses to frequently asked questions and even reconsidering the timing of our single IRB policy to give our grantees time to work through how to operationalize the change. …. Continue reading