Registering Clinical Trial Results: The Next Step

Before the US Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA), trial registration under US law did not require registering the results of clinical trials. Instead, registration was limited to disclosing the purpose of the trial, the eligibility criteria for patients in the trial, and the location of trial sites. In the FDAAA, Congress for the first time directed the National Institute of Health (NIH) to require sponsors of clinical trials of drugs to post at least some results from those trials on ClinicalTrials.gov and also directed the NIH to adopt new regulations by Sep 2010 to require sponsors to post more complete results on ClinicalTrials.gov. Here, Miller looks at the registration of clinical trials, which is an important opportunity for the NIH to improve the quality and reliability of clinical search of drugs.