Tuesday, April 29, 2008
Learn Vs Confirm
I was reading this interesting and thought provoking article on "LEARNING VS. CONFIRMING IN CLINICAL DRUG DEVELOPMENT" by Lewis Sheiner. The article is available freely on the web here. For those who havent read it, please do so. It may be hard to grasp the details in the first attempt, but if you read it more than once (like I am doing) you will start understanding how one can improve clinical drug development program by implementing the learn- confirm paradigm.
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4 comments:
hey ganesh, I have enjoyed reading that too, lew published some philosophical articles on drug development, ones that I liked are, "Is intent to treat anlysis always ever enough", J clin Pharm, 54, 203; "The intellectual health of clinical drug evaluation" CPT july 1991; "Clinical Pharmacology and the choice between theory and empiricism", CPT dec 1989; Lew was often quoted as saying"Statistics should be their handmaiden, not their jailer" a quote by david Salsburg. If you find controversy on hypothesis testing interesting, you will love this one:- "Hypothesis Versus Significance Testing for controlled Clinical trials: A dialogue" D Salsburg Stat in Medicine 1990.
g2: Thanks again for referring the articles and will check them out too. I enjoyed his article "Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval". I am curious to know if you are aware of any drug being approved based on a single clinical trial.
hmm.. I do not know, but it seems difficult, a new chemical entity has to go through phase I and II and also a phase III confirmatory trial. Orphan drugs may get some leverage.
However, given a confirmatory trial and conc-effect or conc-adverse effect relationship (mostly provided by M&S) further trials (eg changein dose or frequency )may not be necessary FDA published some articles on the use of M&S in speeding drug approval. "Impact of Pharmacometric Reviews on New Drug Approval and Labeling Decisions-a Survey of 31 New Drug Applications Submitted Between 2005 and 2006".Clin Pharmacol Ther. 2007 Feb ;81 (2):213-21. "Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications." AAPS J. 2005 ;7:E503-12.
g2: I guess its not possible to bypass Phase I & II for any drug. However, if the number of studies required in Phase III is reduced to just one trial, pharma companies can reduce the cost and time for drug development (and possibly unnecessary exposure in patients). Just my 2 cents. I need to read the article you had cited. Thanks much for sharing, though.
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