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

This reporting requirement applies to new and competing awards made on or after December 13, 2017.  Findings from valid analyses based on sex/gender and race/ethnicity from these applicable NIH-defined Phase III clinical trials must now be reported in ClinicalTrials.gov within one year of completion of data collection for the study’s primary outcome measures. This builds on existing requirements for registering and reporting results in ClinicalTrials.gov. If you have an applicable NIH-defined Phase III clinical trial that was already underway before the effective date, the requirement will not affect you for your current award. When preparing to register your applicable NIH-defined Phase III trial, we encourage you to identify what outcomes relevant to sex/gender and/or race/ethnicity you will need to report in ClinicalTrials.gov.  Keep in mind that most studies will be expected to report results on sex/gender and race/ethnicity for all primary outcomes. We are in the process of developing additional guidance, so stay tuned for more to come.
Source: NIH Extramural Nexus - Category: Research Authors: Tags: blog Open Mike Clinical Trials Clinicaltrials.gov Source Type: funding