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RESEARCH METHDOLOGY
Year : 2010  |  Volume : 1  |  Issue : 2  |  Page : 57-60

Phase IV of Drug Development


Head, Medical Affairs and Research Pfizer Ltd

Correspondence Address:
Viraj Suvarna
Head, Medical Affairs and Research Pfizer Ltd

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Source of Support: None, Conflict of Interest: None


PMID: 21829783

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Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study. Phase IV is also an important phase of drug development. In particular, the real world effectiveness of a drug as evaluated in an observational, non-interventional trial in a naturalistic setting which complements the efficacy data that emanates from a pre-marketing randomized controlled trial (RCT). No matter how many patients are studied pre­marketing in a controlled environment, the true safety profile of a drug is characterized only by continuing safety surveillance through a spontaneous adverse event monitoring system and a post-marketing surveillance/non­interventional study. Prevalent practice patterns can generate leads that could result in further evaluation of a new indication via the RCT route or even a signal that may necessitate regulatory action (change in labeling, risk management/minimization action plan). Disease registries are another option as are the large simple hybrid trials. Surveillance of spontaneously reported adverse events continues as long as a product is marketed. And so Phase IV in that sense never ends.


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