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.
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|
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|