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NIH Clinical Trials

The NIH defines a clinical trial as "a research study in which 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." NIH policy has more requirements for clinical trials than federal regulations, including GCP training and clinicaltrials.gov registration.

All applications for NIH funding require investigators to state whether or not the proposed research meets the NIH defintion of "clinical trial." Investigators do so by answering the folllowing 4 yes/no questions in the application. All answers are "yes" if the study is a clinical trial.

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

 

NIH Dissmentation Policy for Clinical Trial Information

In 2007, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established the need to registration and report information on "applicable clinical trials" on ClinicalTrials.gov. In 2016, 42 CFR Part 11, called the "Final Rule" for Clinical Trials Registration and Results Information Submission, clarified requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. Since 2016, a NIH has introduced a complimentary policy that applies to all clinical trials funded by NIH, regardless of whether they are subject to the Final Rule.  

The NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, effective for competing applications and contract proposals submitted on or after January 18, 2017, states that all NIH-funded awardees and investigators conducting clinical trials will register and report the results of their trial in ClinicalTrials.gov.  
 
NIH is delaying enforcement of this policy until September 24, 2024 for basic experimental studies with humans. However, NIH will continue to expect registration and reporting for these types of studies. 

Funding Opportunity Announcements (FOAs)

NIH funding opportunity announcements (FOAs) now indicate whether or not they are specific to clinical trials. If your research meets the definition of a clinical trial, you must choose a funding opportunity that explicitly allows clinical trials, designated "Clinical Trial Optional" or "Clinical Trial Required." In the future, applications proposing a clinical trial that are submitted to a non-clinical trial FOA will be returned without review.

Though not comprehensive, the NIH provides FAQS and a number of case examples that are useful in interpreting their definition of a clinical trial. For assistance determining whether your research meets the NIH definition of a clinical trial, contact ORP-QM@psu.edu or the NIH Program Officer identified under "Scientific/Research Contacts" in section VII of the FOA.

Proposals for Clinical Trials

Proposals for clinical trials require addtional information and have additional review criteria, such as a dissemination plan regarding how the investigator will fulfill clinicaltrials.gov registration and reporting requirements for NIH-funded clinical trials. The plan must contain sufficient information to assure the following:

  • the applicant will ensure that clinical trial(s) under the award are registered and results information is submitted to ClinicalTrials.gov as outlined in the policy and according to the specific timelines stated in the policy;
  • informed consent documents for the clinical trial(s) will include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov; and
  • the recipient institution has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements.
 
The following Penn State-specific language may be helpful in outlining a dissemination plan:
 

The PI will serve as the responsible party for the clinicaltrials.gov record(s) associated with the study or studies funded by the award. He/she will ensure the trial is registered no later than 21 days after IRB approval, following policy at the Pennsylvania State University. Once a record is established, the PI will confirm the accuracy of record content, resolve problems, and verify and update the record. The PI will also report results and adverse events in clinicaltrials.gov within 12 months of the primary and study completion dates respectively. The Pennsylvania State University Office for Research Protections Quality Management program monitors and enforces investigator compliance with required registration and reporting in clinicaltrials.gov. As the PRS administrators for the University, the Quality Management program assists investigators serving as the responsible party in the registration, record maintenance, and reporting processes, including providing deadline reminders and guidance for resolving errors. As part of the review process, the IRB will confirm that the consent form(s) fulfill NIH policy by requiring a specific statement relating to the posting of the study or studies on clinicaltrials.gov.

GCP Training

All study team members on an NIH-funded clinical trial must complete Good Clinical Practice (GCP) training before a study can receive IRB approval, and the training must be refreshed every 3 years. This is in addition to the human subjects training required by the IRB, which also must be refreshed every 3 years. Penn State offers GCP training through the CITI Program. Please see our our instructions for how to access the training.

Clinicaltrials.gov Registration & Reporting

All NIH-funded clinical trials must be registered and have results reported on clinicaltrials.gov, a public registry and results databased overseen by the National Library of Medicine. By ORP policy, clinical trials must be registered within 21 days of IRB approval. By NIH policy, active registrations must be updated and verified regularly and no less than every 12 months. Results must be reported within 12 months, respectively, of final data collection for the primary outcome and of final data collection for the study as a whole.

Please see our page on ClinicalTrials.gov for more details on registration and reporting requirements.