Tom Krohn recently wrote about our efforts to share more useful clinical trial site contact information with the public on ClinicalTrials.gov. Many of you—as a patients, caregivers, researchers, or curious citizen scientists—may have already visited ClinicalTrials.gov to explore clinical trials. But, for those who haven’t, or for those who would just like know more, we thought it might be helpful to look into the site’s origins and intentions with our latest infographic.
Why Was ClinicalTrials.gov Developed?
The Food and Drug Administration Modernization Act of 1997 (FDAMA) stipulated the creation of:
“A registry of clinical trials…of experimental treatments for serious or life-threatening diseases and conditions…which provides a description of the purpose or each experimental drug… Information provided shall consist of eligibility criteria for participation and a point of contact for those wanting to enroll in the trial, and shall be in a form that can be readily understood by members of the public…”
Text of FDAMA (PDF)
ClinicalTrials.gov launched three years later in 2000 with just a few thousand trials listed. It has since swelled to include more than 170,000 registered trials. While it was originally intended to catalog only trials for “serious or life-threatening diseases,” newer requirements by the International Committee of Medical Journal Editors (ICMJE) and the Food and Drug Administration Amendments Act of 2007 (FDAAA) have resulted in more trials for more types of diseases being added to ClincialTrials.gov.
Many visitors to ClinicalTrials.gov are patients who use the site to research opportunities to join clinical trials. However, the site was created primarily as a transparency tool to ensure sponsors disclose their clinical trials publicly. Since 2008, trial results are to be included on ClinicalTrials.gov.
What Information Can Be Found on ClinicalTrials.gov?
In addition to a general explanation of ClinicalTrials.gov and a timeline, the “About ClinicalTrials.gov” infographic highlights some of the key types of information that can be found on the site in a single clinical trial entry. They include the NCTID number, the type of intervention, the study’s design, the planned outcomes, the eligibility criteria and the results database. Understanding each of these categories and what they mean, can help people fully understand what a trial requires from a volunteer and what it’s trying to achieve, which in turn, helps them to make a decision about participating in the study.
Sharing Information from ClinicalTrials.gov
To support sharing of ClinicalTrials.gov data, the website offers a basic API that allows the download of data from the website to use in their own applications. In fact, our own LCOI-API is sourced from the Clinical Trials.gov API.
Through projects we’re working on surrounding our API, we’re hoping to help technologists and developers better leverage the data available through ClinicalTrials.gov, to build personalized clinical trial tools and resources for people who can benefit from participating in clinical research.
Do you have any thoughts on how data from the site could be enhanced in order to people connect with research that relevant to them? Please let us know via the comments below or send us a tweet.