FDA now has authority over timely and accurate reporting on ClinicalTrials.gov
On September 26, 2012, the U.S. Department of Health and Human Services
(DHHS) announced that it has delegated to the U.S. Food and Drug
Administration (FDA) the authority to make sure that clinical trial
information is being submitted to ClinicalTrials.gov as required and on
time. Click here to see the notice in the Federal Register: https://www.federalregister.gov/articles/2012/09/26/2012-23598/office-of-the-commissioner-of-food-and-drugs-delegation-of-authority.
ClinicalTrials.gov
is an online registry that was created by the National Library of
Medicine in 2000. When it was first established, registration of trials
was voluntary. In 2007, federal legislation was passed requiring most
clinical trials in the United States to be registered on
ClinicalTrials.gov. Registration for observational studies is voluntary.
The registry requires a summary of each trial and some basic
information, such as number of people enrolled, location of the study,
type of study, sponsor, and investigator. Initially there was no
provision for posting results and adverse effects, but now both are
required. Currently, there are more than 100,000 trials on the site, and
more than 300 are added every day. Read more...
Califf to serve as new "collaboratory" principal investigator
The DCRI has been awarded a $9 million grant from the National Institutes of Health (NIH) to serve as the Coordinating Center for the Health Care Systems Research Collaboratory.
The Collaboratory Coordinating Center, a joint venture of the DCRI, the Harvard Pilgrim Health Care Institute, the Group Health Research Institute (GHRI), Johns Hopkins University, and the Center for Medical Technology Policy (CMTP), is intended to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research. The ultimate goal is to ensure that physicians and patients are able to make decisions based on the best available clinical evidence.
The Collaboratory's principal investigator is Robert Califf, MD (pictured), director of the Duke Translational Medicine Institute. Eric Larson, MD, MPH, of GHRI; Richard Platt, MD, MS, of Harvard Pilgrim Health Care Institute and Harvard Medical School; Jeremy Sugarman, MD, MPH, MA, of Johns Hopkins; and Sean Tunis, MD, MSc, of CMTP, will serve as principal investigators for their respective organizations. Drs. Larson and Platt are leaders in the HMO Research Network. The Network is a consortium of 19 health care delivery organizations, many of which will take part in the Collaboratory's projects. Read more...
