How often do US-based human subjects research studies register on time, and how often do they post their results? A statistical analysis of the Clinicaltrials.gov database.

ABSTRACT: The Food and Drug Administration Modernization Act of 1997 (FDAMA) and the FDA Amendment Act of 2007 (FDAAA), respectively, established mandates for registration of interventional human research studies on the website clinicaltrials.gov (CTG) and for posting of results of completed studies. To characterise, contrast and explain rates of compliance with ontime registration of new studies and posting of results for completed studies on CTG. Statistical analysis of publically available data downloaded from the CTG website. US studies registered on CTG since 1 November 1999, the date when the CTG website became operational, through 24 June 2011, the date the data set was downloaded for analysis. Ontime registration (within 21 days of study start); average delay from study start to registration

SUBMITTER: Gill CJ 

PROVIDER: S-EPMC3432835 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature