Why ClinicalTrials.gov?

Its purpose is to help the public find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. As public health investigators, JHSPH faculty conducting clinical trials must register their studies with ClinicalTrials.gov.

 What is a Clinical Trial?
The two agencies responsible for the regulations related to clinical trials, the FDA and the NIH, provide definitions of what constitutes a clinical trial.

 FDA Definition:
Controlled clinical investigations (other than phase 1 investigations) of any U.S. Food and Drug Administration (FDA)-regulated drug or biological product for any disease or condition

Certain studies of FDA-regulated medical devices, excluding small clinical trials to determine feasibility and certain clinical trials to test prototype devices, but including FDA-required pediatric post-market surveillances of a device product. ACTs generally include interventional studies (with one or more arms) of FDA-regulated drug, biological, or device products that meet one of the following conditions:

• The trial has one or more sites in the United States

• The trial is conducted under an FDA investigational new drug application or investigational device exemption

• The trial involves a drug, biological, or device product that is manufactured in the United States or its territories and is exported for research

NIH Definition (expanded in 2017):
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.

 To assist investigators in determining whether or not their studies fall under this new definition, NIH provides a decision tree with four questions:

• 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?

 Note that if the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if you are studying healthy participants, your study does not have a 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; your study is utilizing a behavioral intervention.

Studies intended solely to refine measures are not considered clinical trials. Studies that involve secondary research with biological specimens or health information are not clinical trials.

When?

New studies:

• For new clinical trials, submission requirements are triggered by enrollment. The PI must submit the required information no later than 21 days after the first participant is enrolled.

• Records must be updated no less than once every 12 months, even if there are no changes to the information.

• Results Reporting:

• The PI of the clinical trial is responsible for posting basic study results at the conclusion of the study – within one year of the overall study completion date.

What about commercially sponsored clinical trials?

The study Principal Investigator should consult with the commercial sponsor to ensure that posting the clinical trial on the government website is in accordance with the terms of the study contract. The sponsor of these clinical trials maintains the record within its PRS account. The JHSPH PRS Administrator does not have access to these records.