Trials to Register and Report

There are 4 basic categories under What Trials to register and report:

  1. Clinical Trials funded either in whole, or in part by National Institutes of Health (NIH)
    (applicable to all NIH-funded studies independent of whether the study meets the definition of an applicable clinical trial as detailed below):

https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22379.pdf

  1. Trials that meet the clinical trial definition of The International Committee of Medical Journal Editors (ICMJE) that the investigator may wish to publish: ICMJE journals will consider [for publication] trials beginning on or after July 1, 2005 only if registration occurred before the first patient was enrolled (“prospective registration”).

http://www.icmje.org/about-icmje/faqsclinical-trials-registration/

  1. Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS): The National Clinical Trial (NCT) number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the “Medicare National Coverage Determination (NCD) Manual,” Section 310.1

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1344.pdf

  1. “Applicable Clinical Trials” which include the following:
    • Trials of drugs/biologics. Controlled clinical investigations, other than phase 1 trials of drugs/biological products subject to FDA regs.
    • Trials of devices. 1) Controlled trials with health outcomes of devices subject to FDA regulation (other than small feasibility studies) and 2) pediatric post-market surveillance required by FDA
    • The trial has one or more sites in the U.S.
    • The trial is conducted under an FDA IND or IDE application
    • The trial involves a drug, biologic, or device that is manufactured in the U.S. or its territories and is exported for research

ACT Wizard: http://grants.nih.gov/clinicaltrials_fdaaa/docs/Flow_chart-ACT_only.pdf

Identifying an ACT under FDAAA http://grants.nih.gov/ClinicalTrials_fdaaa/ACTs_under_FDAAA.htm

 

Trials that are Excluded:

      • (Non-serious/life-threatening) Phase 1 drug trials, including studies in which drugs are used as research tools to explore biological phenomena or disease processes
      • Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes
      • Trials that do not include drugs, biologics, devices, or clinical procedures (e.g., behavioral interventions)
      • Non-interventional (observational) clinical research, such as cohort or case-control studies
      • Trials that were ongoing as of September 27, 2007, and reached the Completion Date before December 26, 2007