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Adaptive Clinical Trial Design Publications & Presentations by Founder of Adaptive Plus, LLC

Some of Jonathan R. Smith, Ph.D.'s Recent Adaptive Trial Design Publications:

  1. Pinheiro, J., ...., Smith Jonathan R., 2010, "Adaptive and Model-based Dose-Ranging Trials: Quantitative Evaluation and Recommendations; White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies", Statistics Biopharm. Res., 2(4): 435-454, 466-468

  2. Dragalin, V., ...., Smith Jonathan R., 2010, "A Simulation Study to Compare New Adaptive Dose-Ranging Designs", Statistics Biopharm. Res., 2(4): 487-512 [Within the description and assessment of new methods for Dose-Ranging Clinical Trial Designs, this paper covers the MULTOB Adaptive & Non-Adaptive methods in detail]

Some of Jonathan R. Smith, Ph.D.'s Recent Presentations:

  1. Translational Medicine-Driven Multi-Component Predictive Biomarkers as an Emerging Enabler of Personalized Medicine, DIA 2011 Annual Meeting, Chicago

  2. New and Innovative Design Approaches for Phase III Oncology Trials, with Emphasis on Regulatory Expectations, 1st Pharma Ed Adaptive Trial Designs conference, September 2007, Philadelphia [Presentation covers two types of Adaptive Selection of the Patient Population & many other types of Innovative Clinical Trial Designs and highlights their great benefits in particular cases within Oncology.]

  3. Practical Use of Innovative Design Approaches for Phase III Oncology Trials, DIA 2006 Annual Meeting, Philadelphia [Presentation also had a European Regulatory discussant from BfArM]

  4. Increase in Expected Net Present Value through Study Design Modifications within Phase III, DIA 2005 Annual Meeting, Washington [Presentation illustrates under realistic assumptions re enrollment rates, trial costs, and post-approval costs, how much certain Adaptive Designs (in 2 examples) can greatly increase expected NPV as well as decrease expected trial duration. In another type of example the optimal power level (to maximize expected NPV) is determined for non-adaptive trials under a range of values for peak sales & remaining patent life.]

  5. Accelerating Phase II-III Oncology Drug Development through the use of Adaptive Designs, DIA 2004 Annual Meeting, Washington [Presentation also had a Regulatory discussant from CDER]

  6. Further Developments in the Use of Combination Phase II/III Designs to Accelerate Drug Development, DIA 2003 Annual Meeting, San Antonio [Presentation extends #7 below, by determining numerically the optimal timing of the interim (for the 2 look case), and then deriving numerically the sample size for a given power. Identifies situations for certain 3-arm trials where such seamless Phase II/III combination designs will have lower power.] 

  7. Accelerating Drug Development Through the Use of Combination Phase II/III Designs, DIA 2002 Annual Meeting, Chicago [Presentation covers some of the very earliest work (pre-dating Stallard & Todd, 2003) on Phase II/III designs based on "one-patient, one-vote" by numerical determination of the necessary adjusted critical alpha-values for a given interim fraction & given # of doses. Time and Cost Savings (allowing for over-runs) relative to traditional clinical trial designs shown in example with a 30 day primary endpoint]

Other Adaptive Design Links:

  1. Food and Drug Administration, Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics, February 2010

  2. European Medicines Agency, Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned with an Adaptive Design, CHMP/EWP/2459/02, 18 October, 2007


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