Update to NIAMS Submission of Clinical Trials Applications Policy
Date: April 13, 2016
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) recently revised its current policy to allow R01 applications that include a clinical trial if the primary endpoint is mechanistic, and extended the policy to the Parent R21 FOA. Previously, anything considered an intervention in humans with a health related outcome was considered to be a clinical trial and sent to CSR since it was not allowed in NIAMS policy, limiting translational research funded through NIAMS. As one of the best methods to look at human biology is to look at basic science mechanisms over the course of a clinical intervention, the policy was revised so that applications are allowed to be reviewed by the NIAMS clinical study section as long as the primary objective is mechanistic, either with the hybrid R01 or an entirely human study R01, with some limitations. This change occurred through advocacy by ASBMR members and the dedication of NIAMS to confront and resolve issues faced by researchers. ASBMR commends NIAMS for this policy change and the future value to the field it brings.