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Abstract:

Late phase or postmarketing research is becoming an increasingly important part of pharmaceutical and biotechnology research, as reflected in recent laws that give the FDA strong authority to require such research. Late phase includes disease history, marketing, effectiveness (as opposed to efficacy), comparative effectiveness, long-term safety, and long-term follow-up. These studies pose unique challenges in data quality and statistical methodology. This talk discusses some history and scientific context of late phase research with an emphasis of the role of the biostatistician as an important team member.

And a link for further reading:

http://www.amstat.org/sections/sbiop/BiopharmReport/2012_Winter_BR.pdf