ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 130,000 trials from more than 170 countries in the world.
As a result of pressure from HIV-infected men in the gay community, who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (HOPE or Public Law 100-607) which mandated the development of a database of AIDS Clinical Trials Information System (ACTIS). This effort served as an example of what might be done to improve public access to clinical trials, and motivated other disease-related interest groups to push for something similar for all diseases.
The Food and Drug Administration Modernization Act of 1997 (FDAMA or Public Act 105-115) amended the Food, Drug and Cosmetic Act and the Public Health Service Act to require that the NIH create and operate a public information resource, which came to be called ClinicalTrials.gov, tracking drug efficacy studies resulting from approved Investigational New Drug (IND) applications (FDA Regulations 21 CFR Parts 312 and 812). With the primary purpose of improving access of the public to clinical trials where individuals with serious diseases and conditions might find experimental treatments, this law required information about:
- Federally and privately funded clinical trials;
- The purpose of each experimental drug;
- Subject eligibility criteria to participate in the clinical trial;
- The location of clinical trial sites being used for a study; and
- A point of contact for patients interested in enrolling in the trial.
The National Library of Medicine in the National Institutes of Health made ClinicalTrials.gov available to the public via the Internet on February 29, 2000. In this initial release, ClinicalTrials.gov primarily included information about NIH-sponsored trials, omitting the majority of clinical trials being performed by private industry. On March 29, 2000 the FDA issued a Draft Guidance called Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank and put into In) with the hope that this would increase use by industry. After a second draft guidance was released in June 2001, a final guidance was issued on March 18, 2002 titled Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. The Best Pharmaceuticals for Children Act of 2004 (BPCA or Public Law 107-109 amended the Public Health Service Act to require that additional information be included in ClinicalTrials.gov.
As the result of toxicity tracking concerns raised following retraction of several drugs from the prescription market, ClinicalTrials.gov was further reinforced by the Food and Drug Administration Amendments Act of 2007 (FDAAA or U.S. Public Law 110-85) which mandated the expansion of ClinicalTrials.gov for better tracking of the basic results of clinical trials, requiring:
- Data elements that facilitate disclosure, as required by the FDAAA, as well as operations of ClinicalTrials.gov; and
- "Basic results" reporting.
Trial record life-cycle
The trial typically goes through stages of: initial registration, ongoing record updates, and basic summary result submission. Each trial record is administered by trial record manager. A trial record manager typically provides initial trial registration prior the study enrolls the first participant. This also facilitates informing potential participants that the trial is no longer recruiting participants. Once all participants were recruited, the trial record may be updated to indicate that is closed to recruitment. Once all measurements are collected (the trial formally completes), the trial status is updated to 'complete'. If the trial terminates for some reason (e.g., lack of enrollment, evidence of initial adverse outcomes), the status may be updated to 'terminated'. Once final trial results are known or legal deadlines are met, the trial record manager may upload basic summary results to the registry either by filling a complex web-based form or submitting a compliant XML file.
The National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) held a public meeting on Monday, April 20, 2009, on Expansion of the Clinical Trial Registry and Results Data Bank in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) [Public Law 110-85]. The meeting was held in the Masur Auditorium on the NIH campus, and videotaped for public access. NIH is now considering comments submitted from the public on what should be included in this expansion of the database. One of goals of the expansion is to have more clearly defined and consistent standards for the reporting of clinical trials. This mandate will allow public access of the clinical trial data in this registry data bank, and that the information formats are easily used and compared by the public.
Relationship to PubMed
PubMed is another resource managed by the National Library of Medicine. A trial with an NCT identification number that is registered in ClinicalTrials.gov can be linked to a journal article with an PubMed identification number (PMID). Such link is created either by the author of the journal article by mentioning the trial ID in the abstract (abstract trial-article link) or by the trial record manager when the registry record is updated with a PMID of an article that reports trial results (registry trial-article link). A 2013 study analyzing 8907 interventional trials registered in ClinicalTrials.gov found that 23.2% of trials had abstract-linked result articles and 7.3% of trials had registry-linked articles. 2.7% of trials had both types of links. Most trials are linked to a single result article (76.4%). The study also found that 72.2% of trials had no formal linked result article.
- Clinical trials registry
- Academic clinical trials
- CIOMS Guidelines
- Clinical Trials
- Clinical data acquisition
- Clinical Data Interchange Standards Consortium
- Community-based clinical trial
- Contract Research Organization
- Data Monitoring Committees
- Drug development
- Drug recall
- Electronic Common Technical Document
- Ethical problems using children in clinical trials
- European Medicines Agency
- FDA Special Protocol Assessment
- Investigational Device Exemption
- Medical ethics
- Randomized controlled trial
- World Medical Association
- "Fact Sheet, ClinicalTrials.gov". U.S. National Library of Medicine. May 3, 2011. Retrieved September 16, 2011.
- ClinicalTrials.gov Protocol Registration System, "PRS and U.S. Public Law 110-85, http://prsinfo.clinicaltrials.gov/fdaaa.html
- "NLM: A Report to the Board of Scientific Counselors (April 2013) (TR-2013-001)". Retrieved 20 August 2013.
- "Public Meeting on Clinical Trials podcast and video". NIH. May 20, 2009. Retrieved 2009-05-31.
- "Public Meeting on U.S. Public Law 110-85". Clinicaltrials.gov. May 8, 2009. Retrieved 2009-05-31.
- "PUBLIC LAW 110–85 / 121 STAT. 825". Sep 27, 2007. Retrieved 2009-05-31.
- Huser, V.; Cimino, J. J. (2013). Sampson, Margaret, ed. "Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials". PLoS ONE 8 (7): e68409. doi:10.1371/journal.pone.0068409.
- National Resource for Information on Clinical Trials
- Spanish user guide to ClinicalTrials.gov Galician Health Technology Assessment Agency (Spain)