GUIDANCE ON CLINICALTRIALS.GOV REGISTRATION
ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). This website and database of clinical studies is commonly referred to as a "registry and results database." Trial registration, therefore, serves to promote the public good by ensuring that the existence and design of clinically directive trials are publicly available.
Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Most of the records on ClinicalTrials.gov describe interventional studies but the site also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access).
The Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA or U.S. Public Law 110-85) requires registration of “applicable clinical trials” that are subject to FDA regulations by a “responsible party”.
An APPLICABLE CLINICAL TRIAL(ACT) is a study that:
- Prospectively assigns human subjects to intervention and at least one concurrent control or comparison groups;
- Uses a drug, biologic, or device as the intervention or control/comparison; and
- Studies the safety, efficacy, or cause-and-effect relationship between an intervention and a health outcome.
The registration requirement DOES NOT APPLY to:
- The use of FDA-approved, marketed products used in the course of medical practice;
- Phase I clinical investigations of drugs or biologics;
- Small clinical trials to determine the feasibility of a device, or clinical trial to test prototype devices in which the primary outcome measure relates to feasibility and not to health outcomes;
- FDA-required pediatric post-marketing surveillance of devices; and
- Purely observational studies, meaning those studies in which the assignment of the intervention is not at the discretion of the investigator.
The RESPONSIBLE PARTY is the sponsor of the clinical trial, meaning the person who initiates a clinical investigation:
- For investigator-initiated trials, the lead Principal Investigator is responsible for initiating, conducting, and coordinating the overall clinical trial for registration;
- For sponsor-initiated trials, the sponsor is responsible for registration;
- For trials sponsored or funded wholly or in part by the NIH, the grantee is responsible for registration; as grantee, LSUHSC-NO designates the principal investigator of the trial as the responsible party;
- For trials associated with Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications with the FDA, the IND/IDE holder is responsible for registration; and
- For trials associated with Biologics License Applications (BLA), the person who has submitted the application is responsible for registration.
The sponsor, grantee, contractor, or awardee may designate the Principal Investigator of a clinical trial as the responsible party, provided that the Principal Investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for submitting information under the law. If it is unclear who is responsible for registering an applicable clinical trial, investigators should consult with the sponsor, funding agency, and/or other study investigators to define who the responsible party will be.
Under FDA regulation 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents of Applicable Clinical Trials: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
Effective January 18, 2017, The National Institutes of Health (NIH) Policy on Dissemination of NIH-Funded Clinical Trial Information, requires registration at ClinicalTrials.gov for all clinical trials funded wholly or partially by NIH. NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. This includes Phase 1 clinical trials, and trials that do not involve any FDA-regulated products (such as trials involving only behavioral interventions).
- To determine if a competing application, contract proposal, funded grant, or awarded contract supports a clinical trial which requires registration, follow the decision tool located here.
- Competing applications that include studies that are required to be registered must include as part of the Human Subjects Section of the Research Plan a statement that reads, “This application includes a trial that requires registration in ClinicalTrials.gov.” The study would then need to be registered at the site.
- Non-competing continuation applications (1.e., “progress reports”) that include studies that are required to be registered must include as part of the Human Subjects Section of the Progress Report the following items:
- A statement that reads, “This application includes a trial that requires registration in ClinicalTrials.gov,”
- The National Clinical Trial (NCT) number (i.e., the ClinicalTrials.gov number),
- Brief Title as listed in ClinicalTrials.gov, and
- The name of the individual or entity responsible for registering the study (responsible party) for each study being conducted under the application. (As grantee, LSUHSC-NO designates the lead investigator of the trial as the responsible party.)
- If a Competing or Non-Competing Application does not include studies that are required to be registered, the Human Subjects Section of the Research Plan should include a statement that reads, “This application does not include a trial that requires registration in ClinicalTrials.gov.”
The International Committee of Medical Journal Editors (ICMJE) Initiative
The International Committee of Medical Journal Editors (ICMJE) Initiative requires investigators or sponsors to register clinical trials in the Protocol Registration System (PRS) of ClinicalTrials.gov as an a priori condition for publication.