Wednesday, March 24, 2010

The Importance of Phase 4 Clinical Research

Often the question arises - What is the importance of Phase 4 clinical research? In an industry, that is heavily regulated and scrutinized, pharmaceutical brands must not only go through Clinical Study Phases 1, 2 and 3 to validate the drug's safety and tolerability, but as well, testing of the product to monitor its safety and effectiveness in a real-world setting and after the product is approved for marketing is a must and is required by FDA.

Post-marketing clinical research trials, used interchangeably with Phase 4 testing, is a phase that takes place after a product is available on the market for public use and is subsequently used to track a product's safety and tolerability in a real-world setting. Marketers in the pharma industry know that the clinical research needed to market and sell a drug product is quite different than research needed to gain FDA approval.

In addition to post-marketing surveillance, Phase 4 clinical studies are also helpful in developing a marketing strategy for a product. In fact, post-marketing research gives insight into questions and concerns raised earlier in Pre-Clinical and Clinical Phases 1,2 and 3. Not only does Phase 4 research allow pharma companies to monitor for real-time effectiveness, long-term safety and tolerability, but it may also give rise to evidence for possible new indications, new markets for which the drug product had not been initially approved. The value of conducting post-marketing clinical research is required by FDA to continue to ensure patient safety post-submission, post-approval, post-marketing. In my opinion and to ensure data with integrity, monitoring post-marketing clinical studies requires quality control, good clinical practice, quality standards of conduct and operation as well as regulatory rigor. Monitor the monitors. QC/QA the data.

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