Benefit and Risk is Part of Clinical Science Investigation

There is a new group in town;

If you believe that the more you understand, the better your ability to work as an effective statistician in pharmaceutical research, then this may be for you.  Here’s an extract from the first newsletter of the Quantitative Sciences in the Pharmaceutical Industry (QSPI) benefit-risk working group (BRWG) – part of the American Statistical Association (ASA) Biopharmaceutical Section.

Understanding the benefit-risk ratio of new medicines is at the core of drug development— from early stages through approval and reimbursement. New information constantly becomes available via the lifecycle of a medication, and the benefit-risk ratio needs to be continuously assessed how to lose belly fat fast. This process requires a deep understanding of the underlying data, including its strengths and limitations. Thus, statisticians play a key role in this multidisciplinary approach. The environment is extremely complex, with many stakeholders having a different perspective. Furthermore, the development of new approaches or the advancement of available methods progresses rapidly.”

This is a very exciting time in statistics.

If you want to learn more, consider the FDA draft PDUFA V implementation plan on Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making  and several other benefit-risk guidance/recommendations, including ones from FDA CDRH, PROTECT, EMA, and ISPOR, which have been widely reviewed and discussed in recent years.


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