Clinical Trials Corner

In addition to featuring clinical trials that PEDSnet is leading or active in, the Clinical Trials Corner aims to be a general reference for current developments and resources in the world of pediatric clinical trials.

Resources

NIH Clinical Trial Protocol Template provides a standard format with instructional and sample text that NIH funded investigators can use when preparing protocols for phase 2 or 3 clinical trials that require an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) application.

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. It is maintained by the National Institutes of Health (NIH).

NIH Clinical Research Trials and You maintains a library of resources for individuals interested in conducting as well as participating in clinical research trials.

CenterWatch's mission is to be the leading source of clinical trials information for both clinical research professionals and patients.

The PCORI Advisory Panel on Clinical Trials advises PCORI, and agencies, instrumentalities, or other entities conducting research through the PCORI Methodology Committee. 

Summary of ClinicalTrials.gov Reporting Requirements

Reporting Requirement FDAAA Final Rule Final NIH Policy ICMJE Policy
Effective Date January 18, 2017
*Applies to all studies whose "study start date" was on or after effective date
January 18, 2017
*Applies to all new applications for funding submitted on or after effective date, does not apply to ongoing trials unless up for competitive renewal
July 1, 2005
*Applies to all trials that began enrollment on or after this date, or ongoing clinical trials that were still collecting, cleaning, or analyzing data as of July 1, 2005
Scope Registration & Results Data Reporting Registration & Results Data Reporting Registration
Phase II – IV (not Phase I or small pilot/feasibility) All Phases All Phases
Intervention Type Drugs, Biologics & Devices regulated by the FDA Interventional trials (all including behavioral interventions) Intervention trials (all)
Funding Any NIH (partially or wholly funded by) Any
Registration Requirement Within 21 days of enrollment of 1st subject Within 21 days of enrollment of 1st subject Prior to enrollment of 1st subject
Results Reporting Requirements Within 12 months of “primary completion” date Within 12 months of “primary completion” date Not required but encouraged
Enforcement Criminal proceedings and civil penalties (up to $10,000/day); Loss of HHS funding Loss of NIH funding Refusal to publish