ClinicalTrials.gov, as you probably know, is the world’s largest public clinical research registry and results database. It provides information on more than 320,000 clinical studies on a wide range of diseases and conditions. It’s a tremendous resource, but it’s not without its problems.

We’ve written here in the past about how challenging it can be for sponsors to register their trials with ClinicalTrials.gov as they are supposed to, and also about the costs that might be associated with failure to register properly. Now, change is in progress.

A Multiyear Improvement Plan is Underway

ClinicalTrials.gov is 20 years old this year, and its parent, the US National Library of Medicine (NLM), has been considering how to strengthen the site for the future. To that end, the NLM kicked off a multiyear modernization effort on December 30th of last year by issuing a Request for Information (RFI) regarding how the site might be improved.

“We really want to ensure that we are understanding the needs of our users as we move forward with developing a roadmap for what modernization will look like,” the NLM wrote.

The public was asked to consider three main topics:

· Website functionality of ClinicalTrials.gov website and application programming interface (API)

· Information submission using the ClinicalTrials.gov Protocol Registration and Results System (PRS)

· Data standards that may support submission, management, or use of information content

Under these three main topic areas were 11 specific sub-question prompts. The public was also invited to upload attachments as part of any response.

The deadline for responses was March 14th of this year. The NLM reportedly received input from 268 individuals. A virtual public meeting regarding the responses the NLM received took place on April 30th. Anyone interested in the details of these communications and events can find them on the NLM webpage devoted to ClinicalTrials.gov modernization efforts.

Your Suggestions are Welcome

If you missed the RFI, but still want to weigh in on how ClinicalTrials.gov might be improved, don’t fret. The NLM states that it is always open to suggestions and comments via email at register@clinicaltrials.gov.

We hope the refresh of ClinicalTrials.gov will yield a more user-friendly experience for both sponsors who are required to register trials and those individuals who go to the site looking for information. Whether it does or doesn’t, know that you can always turn to us at TBG for help.