US congress committee calls for tougher action on trial sponsors who fail to meet reporting deadlines | The BMJ

"A US congress committee has criticised the Food and Drug Administration (FDA) and National Institutes of Health (NIH) for taking “only modest compliance action” against clinical trial sponsors who have not published results.1

Under US law, clinical trial sponsors are required to submit their results within one year of the completion date. Research looking at compliance in recent years found, however, that over 5000 trials were in “violation of applicable reporting requirements,”2 while over half (37 of 72) of reviewed trials that were funded by the NIH had failed to comply with applicable reporting requirements.3

The US Congressional Committee on Energy and Commerce has written to ask why the FDA and NIH have failed to sanction trial sponsors who break reporting rules...."