ClinicalTrials.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 studies on a wide range of diseases and conditions. Most of the records on ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access). Studies listed in the database are conducted in all 50 States and in 216 countries. ClinicalTrials.gov does not contain information about all the clinical studies conducted in the United States because not all studies are required by law to be registered (for example, observational studies and trials that do not study a drug, biologic, or device).

How to search studies

• Registered studies from all 50 states and 216 countries.
• Studies being conducted at Oklahoma State University.

Relevancy

Certain FDA-regulated studies, NIH-funded studies, and other unfunded studies with an intent to publish in an ICMJE journal require registration in ClinicalTrials.gov.

FDA Registration Requirements

The Food and Drug Administration (FDA) requires registration at ClinicalTrials.gov for all applicable clinical trials (ACTs) that were initiated after 9/27/2007, or were initiated before 9/27/2007, but were ongoing as of 12/26/2007. Applicable drug and device clinical trials are defined as follows:

Drugs and Biologics: A controlled clinical investigation, other than a Phase 1 clinical investigation, of a drug or biologic product subject to FDA regulation.

Medical Devices: A prospective clinical study of health outcomes comparing an intervention with a medical device against a control, or pediatric post-market surveillance required by the FDA.

Registration is not required for small trials to determine the feasibility of a device or to test prototype devices where the primary outcome measure relates to feasibility, and not to health outcomes.

Here is a provided checklist for determining whether your FDA-regulated study is required to be registered at ClinicalTrials.gov.

NIH Registration Requirements

Effective January 18, 2017, the National Institutes of Health requires registration of funded Clinical Trials (fully or partially funded). NIH defines a clinical trial as: a study where one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

The following questions should be used to determine whether a study meets the NIH clinical trial definition:

• Does the study involve human participants?
• Are the participants prospectively assigned to an intervention?
• Is the study designed to evaluate the effect of the intervention on the participants?
• Is the effect being evaluated a health-related biomedical or behavioral outcome?

If the answers are all “yes,” the study is a clinical trial.

NOTE: If the answer to all four questions is yes, your study meets the NIH definition, even if:

• You are studying healthy participants;
• Your study is a single intervention with no comparison group (e.g., placebo or control)
• Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug; and
• Your study is utilizing a behavioral intervention.

You may use the Decision Tree for NIH Clinical Trial Definition and the Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial? to determine whether your NIH-funded study is required to be registered at ClinicalTrials.gov.

ICJME Registration Requirements

In 2005, member publications of the International Committee of Medical Journal Editors (ICMJE) required that all clinical trials be registered. The ICMJE defines a clinical trial as:

“…any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events."

For trials that began enrolling participants on or after January 1, 2019, ICMJE requires a Data Sharing Statement.

For information to help determine whether your ICMJE study is required to be registered at ClinicalTrials.gov, you may check out ICMJE-Clinical Trials Registration.

How are clinical trials registered?

Clinical trials are registered via a web-based protocol registration system (PRS).

Setting up an account can take time, so plan accordingly.

Important: The Oklahoma State University CHS PRS Account Administrator role is to help establish an account. The PRS Account Administrator is not responsible for registering, ensuring compliance with timelines, entering results, or verifying accuracy of information.

Who is responsible for registering a study?

Research needs to know who the “responsible party” is. Penalties can be levied against the responsible party for failing to meet requirements. Penalties can include:

• Monetary fines;
• Withholding federal funds;
• Denial of publication in an ICMJE journal.

Responsible party definitions

FDA-regulated studies

• The sponsor of the clinical trial, or
• The principal investigator (PI) of such clinical trial if so designated by the sponsor, grantee, contractor, or awardee, so long as the PI 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 can meet all of the FDA’s requirements for submission of clinical trial information.
• For research involving an IND (investigational new drug application) or IDE (Investigational device), the holder of the IND or IDE is the responsible party unless responsibility has been delegated to the principal investigator

NIH-funded studies

The awardee or the investigator is responsible for registering the study and posting a copy of the informed consent form.

ICMJE requirements

The ICMJE expects the authors to ensure that the study is registered appropriately.

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.

Multiple institutions

The lead sponsor should be responsible. In the case that there is no sponsor, investigators must work together to determine who will be fulfilling the obligation.

What are the compliance timelines?

• Registration must be within 21 days after enrollment of the first subject.
  • For ICMJE, registration must be at or before the time of first subject enrollment.
• Study information must be updated no less than annually.
• If recruitment status, IRB status, or administrative information about the study (e.g., responsible party, study title, contact information) changes, registration must be updated within 30 days.
• When the study is closed to enrollment, no later than 60 days after the last study visit of any subject.
• Results submission and adverse events must be submitted no later than 1 year after the completion date of primary outcomes.