MU-iCATS
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Chronological Events
Clinical Trials Registry
November 1997
FDA Modernization Act mandates registration- Studies of treatments of services or life-threatening diseases and conditions
- Any funding source
- NLM (National Library of Medicine) with FDA develop clinicaltrials.gov
February 2000
clinicaltrials.gov available on the InternetMarch 2000
FDA issues initial draft guidance on registrationSeptember 2000
Medicare NCD (National Coverage Decision) on routine costs of clinical trials allowed IF trial is registered in proposed HCFA registryMarch 2002
FDA issues final guidance on registrationOctober 2003
WHO (World Health Organization) begins dialogue on registrationSeptember 2004
ICMJE (International Committee of Medical Journal Editors) issues joint editorial – publication only if registered prior to first enrollment. ICMJE endorses WHO initiatives.November 2004
WHO issues recommendation for ICTRP (International Clinical Trials Registry Platform) during the WHO Ministerial Summit on Health Research held in Mexico CityMay 2005
WHO Trials Registry recommendations approved by the World Health AssemblyJuly 2005
ICMJE considers trials beginning on or after July 1, 2005 if registered prior to first enrollmentAugust 2005
FDA launches education campaign for sponsorsAugust 2005
WHO creates ICTRP, which draws on existing registriesJanuary 2006
AAMC (Association of American Medical Colleges) calls for registration and formally endorses ICMJE definitionMay 2006
WHO specifies 20 key data elements for clinical trials registriesJuly 2006
Medicare begins reconsideration of clinical trials policy, including HCFA registry which was never establishedDecember 2006
Medicare Coverage Advisory Committee recommends using clinicaltrials.gov in lieu of proposed HCFA registryJune 2007
ICMJE, in a NEJM editorial, expands and clarifies definition of types of trials to be registered, adopting WHO’s definition for trials beginning on or after July 1, 2008July 2007
Medicare calls for additional public commentSeptember 2007
Medicare CMS Transmittal clarifies routine costs, with no mention of clinicaltrials.govSeptember 2007
FDAAA (Food & Drug Administration Amendments Act) of 2007 signed into law, including expansion of registration requirements for drug and device clinical trialsOctober 2007
NEJM (New England Journal of Medicine) publishes editorial reiterating ongoing support for clinical trials registration and the requirements of the FDAAA of 2007December 2007
Registration deadline for applicable clinical trials.September 2008
Results reporting implementation (due within 12 months of primary completion date of applicable clinical trials).Future Related Dates
March 2009
Public meeting for input on 2010 rulemakingSeptember 2009
Adverse Event reporting implementationSeptember 2010
Rulemaking due for expanded results database