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Keaven Anderson Merck Research Laboratories April 17, 2013

SMART Studies A Naïve Industry Perspective University of Pennsylvania 6 th Annual Conference on Statistical Issues in Clinical Trials. Keaven Anderson Merck Research Laboratories April 17, 2013. Industry Priorities?. Get drug approved Find best use of drug in practice

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Keaven Anderson Merck Research Laboratories April 17, 2013

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  1. SMART StudiesA Naïve Industry PerspectiveUniversity of Pennsylvania6th Annual Conference on Statistical Issues in Clinical Trials Keaven Anderson Merck Research Laboratories April 17, 2013

  2. Industry Priorities? • Get drug approved • Find best use of drug in practice • Given these priorities, might pharma companies invest in SMART trials? • Will the usual path be through large collaborations? (e.g., I-SPY business model?) • Is there a simple model for a pharma company to consider? • My hope is that I am a straight man for presentations in the afternoon…

  3. Possible Simple Case? • “Oncologists prefer sequential monotherapies over combination therapies for indication X.” • Let • C=control monotherapy • E=experimental monotherapy • E+C=combination of E and C

  4. Possible designs C Best simple chance for E to win? Randomize E+C We worry that this is really an (uncontrolled) comparison of C E’ Randomize E+C ?

  5. Possible designs C Best simple chance for E to win? Randomize E+C C Allows upside of substituting E for C Randomize E+C E C Usual care Allows drug approval and optimizedsequencing Randomize E+C Usual care E C

  6. Invest in Blue Design? C Usual care • Straightforward regulatory path for E+C or E • Adds evaluation of sequential vs up-front combination • Not outrageously expensive • “Controls” treatment sequence • Allows evaluation of different strategies • Comparison of E+CUC to EC has value for providers • Is this a simple SMART trial? Allows drug approval and optimizedsequencing Randomize E+C Usual care E C

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