For registration purposes, how is “clinical trial” defined and what are the registration deadlines?
According to the International Committee of Medical Journal Editors (ICMJE): 2005 definition statement;” Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. The trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration.” This definition specifically excluded Phase I trials. 2007 definition statement: ” Any research study that prospectively assigns human participants or groups of humans to one or more health- related interventions to evaluate the effects on health outcomes.” This definition includes Phase I trials. Deadlines for registration: Currently, the ICMJE follows its 2005 definition. The ICMJE will start to implement the expanded (2007) definition for all trials that begin enrollment on or after July 1, 2008. The ICMJE will not strictly impose this exp
