For those of you who believe that registering a trial on ClinicalTrials.gov (CT.gov) is quick and easy and nothing more than a rubber stamp, our analytics may prove you wrong. Believe it or not, as of May 1st, we are still finding trials that began the process in Jan and just getting approved in May! Our own experience puts the process at no less than 10 days. Why the delay? It appears that the NIH are attempting to improve the data input and focus on the endpoints being measured. If you attempt to provide soft endpoints, there will be push back and delays.
Below is a comparison by months for the past 4 years. This is the data through May 1, 2016:
Given the fact that there are delays in approval for the registration process and it looks to be taking in excess of 30 days in many cases and up to 90 days in some extreme cases, the 837 trials registered in April (yellow bar = 837) will grow dramatically when we look at the data on June 1st and July 1st.
Our team downloads and scrubs CT.gov every week. The graph above was data from May 1st. The below graph is data from May 8th and you can see the differences:
In one week April 2016 registrations grew in excess of 250 trials. Six of these trials were intiated in January, thirteen in February and thirty nine in March. These 58 trials on average took more than 40 days to get approved.
The moral of this story is to make sure your protocol is tight and your endpoints are easily measurable when you prepare for getting your trial registered on CT.gov.