Post-registration clinical studies

Post-registration clinical studies are defined as any study that is conducted after Health Canada s Notice of Compliance (NOC) has been issued for a medicine. 

The main goal of a post-registration clinical study will be to obtain and evaluate data on safety and/or efficacy, cost-effectiveness, quality of life or other socioeconomic factors that have to do with clinical use of the medicine. 

Post-registration clinical studies must provide a scientific framework for investigation of the medicine in broader or special populations. 

All post-registration clinical studies must have a clearly defined goal that is amenable to scientific review and testing. 

Post-registration clinical studies must be carried out in accordance with the Canadian Food and Drugs Act and Regulations, other applicable federal and provincial legislation, and guidelines issued by Health Canada. 

Post-registration clinical studies must be carried out using a written protocol that will provide answers to specific research questions. The protocol must be designed to ensure scientifically meaningful results, and should contain details about study objective, study population, methodology, information to be obtained and data collection method. 

These deliberations may result in several outcomes. Clinical development may continue as planned, but additional vigilance with more frequent visits and special tests may be added. The dose may be reduced or certain at-risk subjects may be excluded from further trials. The drug may proceed to registration, but the authorities may stipulate that a post-marketing surveillance study be conducted. The drug may even be withdrawn from further clinical development. 

Usually clinical studies follow three consecutive phases, I, II, and III. An additional post-registration study may be required, designated Phase IV (Acceturi et al., 1997 CNS, 1997). In some instances, intermediate phases are carried out, I/II, Ia/Ib, etc. 

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