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Participation

Infographic: What is ClinicalTrials.gov?

WhatisClinicalTrials.gov FeatureImage 9Jan2020-01

Editor's Note: This blog was first published in 2014, but with several recent updates to ClinicalTrials.gov search functionality and the 20th anniversary of the site on February 29, we felt a refresh of our infographic was in order. This year, the NIH has issued a Request for Information (through March 14, 2020) to continue to modernize the site, based on broad input. Follow the link provided at the end of this article to submit your feedback on website functionality, information submission processes, and use of data standards.

Many of you—as 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, as we acknowledge its 20th anniversary this year.

WhatisClinicalTrials.gov Infographic 29Jan2020

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 325,857 in 50 states and 209 countries. 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 that 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 NCT 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 participant and what the trial is trying to achieve, which in turn, helps people decide about participating in the study.

Do you have any thoughts on how data from the site could be enhanced in order to help people connect with research that may be relevant to them? Please let us know on Twitter or provide your feedback directly through the NIH Request for Information (deadline is March 14).

Blog post originally appeared on LillyPad.

References used for the infographic:

  1. https://clinicaltrials.gov/ct2/about-site/background
  2. https://clinicaltrials.gov/ct2/resources/trends#RegisteredStudiesOverTime
  3. https://clinicaltrials.gov/ct2/about-studies/glossary
  4. https://clinicaltrials.gov/ct2/resources/trends/
  5. https://ippcr.nihtraining.com/handouts/2012/Zarin0305_13.pdf
  6. https://clinicaltrials.gov/ct2/manage-recs/background
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