| RESEARCH METHDOLOGY |
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| Year : 2010 | Volume
: 1
| Issue : 2 | Page : 57-60 |
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Phase IV of Drug Development
Viraj Suvarna
Head, Medical Affairs and Research Pfizer Ltd
Correspondence Address:
Viraj Suvarna
Head, Medical Affairs and Research Pfizer Ltd
 Source of Support: None, Conflict of Interest: None  | Check |
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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