NIH's Deputy Director for Extramural Research Clarifies Compliance Requirements for Clinical Trials


With the “final phase of implementation” looming for new mandates related to NIH-supported clinical trials, Michael Lauer, the agency’s deputy director, has explained how investigators will know whether the requirements apply to their research. In his Aug. 11 post on the “Open Mike” blog, Lauer stated that the initiatives are “aimed at improving the quality and transparency” of clinical trials. The definition of such “encompasses a wide variety of study types,” he wrote. “These range from mechanistic studies to behavioral studies, to pilot/feasibility studies, all the way to large-scale efficacy and effectiveness trials.” The requirements include the use of single institutional review boards for trials with more than one site, registration on and specialized training for investigators. NIH is also making available resources to aid compliance, available on a single website. The address is: