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

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

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Due Dates on Holidays/Weekends/NIH Office Closures

With winter weather upon us, remember that when a due date falls on a weekend, Federal holiday, or when Washington, D.C.-area Federal offices close (due to severe weather, for example), the application deadline is automatically extended to the next business day. See NIH Guide Notice NOT-OD-17-041 for additional details. If you suspect Federal offices in D.C. are closed due to severe weather you can …. Continue reading

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Reminder: Changes for January 25, 2018 Application Due Dates

Two major changes impact applications submitted for due dates on or after January 25, 2018.

Applicants are required to use FORMS-E. Wondering what this means for late applications or reviewers submitting under the continuous submission policies? See NIH Guide Notice NOT-OD-17-062 to learn more.
Applications that include one or more clinical trials must be submitted in response to funding opportunity announcements that allow for clinical trials. See NIH Guide… Continue reading

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

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

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