What is clincialtrials.gov?
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 trials on a wide range of diseases and conditions.
The purpose of Clinicaltrials.gov is to share key information with the public about current and past clinical trials. Clinicaltrials.gov captures significant summary information before and during the clinical trial as well as summary results and adverse event information of a completed clinical trial. Federal laws and regulations as well as editors of prominent medical journals require registration of a clinical trial, as described below.
Clinical trials are generally submitted (that is, registered on the website) when they begin. Information on Clinicaltrials.gov is provided by the sponsor or principal investigator (PI), who updates the information throughout the clinical trial. In some cases, results of the clinical trial are submitted after the clinical trial ends. Website commonly referred to as a "registry and results database", this website is a publicly available database of federally and privately supported clinical trials conducted in the United States.
Who is responsible for registering a trial?
By law, the “responsible party” must register a clinical trial. The responsible party is defined as:
- The sponsor of the clinical trial
- The principal investigator (PI) of the clinical trial if so designated by a sponsor, grantee, contractor, or awardee. For most clinical trials, the PI should register the clinical trial, since it is the PI who is responsible for conducting the clinical trial, has access to and control over the data, has the right to publish the results of the clinical trial, and has all of the information necessary to complete the registration.
For those clinical trials that involve an application for an Investigational New Drug (IND) or Investigational Device Exemption (IDE) the responsible party may be someone other than the PI. In the case of an industry sponsored clinical trial, the company may register the clinical trial. If the PI receives NIH or other government funding for a clinical trial, particularly those that do not include an IND or IDE application, the PI is the responsible party. To ensure that any extramurally funded clinical trial is properly registered, the PI should contact the sponsor for clarification.
For clinical trials that are being performed at multiple institutions, the lead sponsor should take responsibility for registering the clinical trial. If the PI is not the lead sponsor, he or she should work with the other investigators and sponsors to ensure that the clinical trial is registered only once for the entire project.
For investigator-initiated clinical trials, whether or not there is industry funding or, in fact, if there is no funding, the PI is considered the sponsor and is responsible for registering the clinical trial.
NOTE: Children’s National Hospital has delegated responsibility for clinical trials registration, periodic updates, and results and adverse event reporting for investigator-initiated studies to the Principal Investigator (‘Responsible Party’).
What Trials need to be registered?
Several agencies govern clinical research. If a clinical trial meets any one of these definitions, the clinical trial must be registered.
- Clinical Trials funded either in whole, or in part by National Institutes of Health (NIH) (applicable to all NIH-funded studies independent of whether the study meets the definition of an applicable clinical trial as detailed below):
- Trials that meet the clinical trial definition of The International Committee of Medical Journal Editors (ICMJE) that the investigator may wish to publish:
- ICMJE journals will consider [for publication] trials beginning on or after July 1, 2005 only if registration occurred before the first patient was enrolled ("prospective registration"). http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
- Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS):
- The National Clinical Trial (NCT) number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1 https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN...
- “Applicable Clinical Trials (ACT)” which include the following:
- Trials of Drugs/Biologics: Controlled, clinical investigations of a product subject to FDA regulations. This includes preliminary studies or phase I trials to be published in an ICMJE journal.
- Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.
Applicable Clinical Trials generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions.
- The trial has one or more sites in the U.S.
- The trial is conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) application
- The trial involves a drug, biologic, or device that is manufactured in the U.S. or its territories and is exported for research
The following trials are generally excluded (unless funded either in whole, or in part by NIH):
- (Non-serious/life-threatening) Phase 1 drug trials, including studies in which drugs are used as research tools to explore biological phenomena or disease processes
- Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes
- Trials that do not include drugs, biologics, or devices (e.g., behavioral interventions)
- Non-interventional (observational) clinical research, such as cohort or case control studies
- Trials that were ongoing* as of September 27, 2007, and reached the Completion Date before December 26, 2007
(*An “ongoing” trial has enrolled one or more subjects and the final subject has not been examined or received an intervention for the purpose of collecting data on the primary outcome).
The Children’s National Principal Investigator (PI) should consult with commercial sponsors to assure that posting of a trial is in accord with terms of the study contract. A Sponsor providing drug only generally does not accept the registration and results reporting responsibilities. Generally for IND or IDE studies, the responsibility rests with the local investigator.
When should studies be registered?
NOTE: It is the policy of the Children’s National that registration of trials meeting any of the criteria outlined in this Policy must be submitted to ClinicalTrials.gov concurrently with initial IRB submission. If the trial has not been registered at that time, the PI may indicate the National Clinical Trial (NCT) number is “pending” and report the NCT number immediately after obtaining from ClinicalTrials.gov. It is the responsibility of the Children’s National PI to notify the IRB as soon as the NCT number has been obtained by submitting a change in research application. The Children’s National PI will also be reminded at the time of the continuing review application to indicate the NCT number.
The different governing bodies require different registration dates. More specifically, the ICMJE and FDAAA have strict timelines:
- ICMJE requires trial registry at or before first patient enrollment as a condition for publication
- The Food and Drug Administration Amendments Act (FDAAA) requires that the Responsible Party for an Applicable Clinical Trial must submit required clinical trial information through the Protocol Registration and Reporting System (PRS) no later than 21 days after enrollment of the first participant.
The Responsible Party should be aware that ClinicalTrial.gov must review all registrations prior to making them viewable to the public. The review process usually takes 2-5 business days and may result in comments that must be reviewed and responded to. Your trial has not been fully registered until you receive an e-mail from ClininicalTrial.gov indicating your trial record has been approved and providing your NCT number.
The format for the ClinicalTrials.gov registry number is “NCT” followed by an 8-digit number, e.g.: NCT00000419.
who can help me register my clinical trial?
The CTSI-CN offers:
- Guidance on interpretation for clinical trials registration requirements, including those of FDAAA, International Committee of Medical Journal Editors (ICMJE), Center for Medicare and Medicaid Services (CMS), and National Institutes of Health (NIH).
- One-on-one assistance for investigator initiated trials requiring results reporting including account creation; reviewing, approving, and releasing records; and helping investigators respond to problems and correct records.
- Soon, we will have biostatistics-level support for investigators who require help with methods and results reporting.
Beyond our support staff, the institution has also purchased access to the CITI course on Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov. For those that are unfamiliar with ClinicalTrials.gov, this course is excellent and covers party responsibilities, protocol registration, summary results information submission, and more.
Who should I contact for more information?
Please contact us at firstname.lastname@example.org should you have any questions. One of our ClinicalTrials.gov specialists will respond to your inquiry with 48 hours of receipt.