Most Clinical Trials Do Not Report Results on Clinicaltrials.gov 
​[Posted on: Thursday, 21 January, 2016] 

Since, 2007, it has been mandatory to register most clinical trials on the government clinical trial registry, clinicaltrials.gov. According to the same law, results of clinical trials must be posted within 12 months of the completion date. Failing to do either could lead to penalties of $10,000 per day till the violation is corrected. A survey of the clinical trials registered with clinicaltrials.gov indicates that only about 15% of completed studies have results reported for them; about 17000 out of 107000 completed studies. A closer look at studies listed since 2008 indicates that the number of completed studies with results is slightly higher, 18%, but still way below expected based on the applicable law. Even for the trials where results are posted, it seems very low quality data is being submitted with no access to raw data, or any practical information about the trial conduct such as location of sites, list of deviations, and detailed statistical analysis. Te law requires delayed publication of results by up to 30 days post approval by FDA, but the large number of trials with no results indicates, sponsors are finding other ways to be non-compliant. In another study, a random sample of 411 journal articles published based on clinical trials also rarely gave data that could be useful for readers. One 1 out of 411 published the clinical protocol, and no study provided direct access to raw data. Also, only 16 studies contained reproducibility data or were used for meta analysis to compare with other similar studies. This does raise concerns for the reliability of publicly available data. There is no publicly available data on any penalties imposed by FDA on non-compliant companies. Let’s hope that with questions being raised in various publications, the regulators will pay attention and enforce the law.