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（项目3 : 适应型治疗效验）
适应型设计一边削减成本一边有可能加速治疗的效验。其因应证据的累积，在治疗效验进行中，能调整用量、适格基准、样品尺寸、或治疗法。适应型治疗效验的最终目标乃运用最有效的方法带给患者最新的技术。第5届召开的年度会议Adaptive Clinical Trials，处理在开发计画中的适应型设计、适应型设计的贝氏分析（Bayesian analysis）、用量范围研究、利用生物标志的治疗效验、与适应型设计有关的法规上课题等各种话题。 RECOMMENDED SHORT COURSE* (SC4) Adaptive Clinical Trials: Strategies and Tools
*Separate registration required WEDNESDAY, SEPTEMBER 7 7:00 am Registration and Morning Coffee
THE USE OF ADAPTIVE DESIGN IN PRACTICE 8:30 Chairperson's Remarks Jose Pinheiro, Ph.D., Senior Director, Biostatistics, Johnson & Johnson Pharmaceutical Research and Development, LLC
9:10 FDA Draft Guidance on Adaptive Designs: Overview, Key Messages, and Impact Jose Pinheiro, Ph.D., Senior Director, Biostatistics, Johnson & Johnson Pharmaceutical Research and Development, LLC The draft guidance on Adaptive Designs (AD) clarifies the FDA position on a wide range of topics related to the planning, execution and analysis of AD, being expected to have a major impact on the future utilization of these methods in clinical drug development. Pharmaceutical companies and the industry trade association, PhRMA, were actively engaged in reviewing the guidance to provide timely feedback to FDA. This presentation will provide an overview of the guidance, focusing on key regulatory concerns and recommendations on the use of AD in clinical trials, and discussing its potential impact on clinical development, as well as reactions from the pharma industry to its release. 10:10 Networking Coffee Break in the Exhibit Hall with Poster Viewing 10:50 The Continual Reassessment Method as a Prototype Adaptive Trial Design: Lessons and Implications Steven Piantadosi, M.D., Ph.D., Phase One Foundation Chair and Director, Samuel Oschin Comprehensive Cancer Institute This talk will discuss some of the history and underpinnings of the modified continual reassessment method (CRM) for dose-finding in oncology from the viewpoint of adaptive clinical trial design. The CRM is typical in some ways as a Bayesian design and atypical in others, making it a useful example to understand strengths and weaknesses of adaptive designs. The use of this design for dose-finding in oncology will be discussed as a starting point for reflecting on adaptive designs broadly. Most of the discussion will focus on the CRM itself and dose-finding versus dose-ranging, but some implications for later developmental designs will be highlighted. Practical implementation of the CRM will be illustrated using software developed by the author. 11:20 Sponsored Presentation (Opportunity Available) 11:50 Adaptive Clinical Trials in Neurology Michael Krams, Ph.D., Vice President, Neurology Franchise, Johnson & Johnson 12:20 pm Using Adaptive Designs and Bayesian Statistics to Enhance the Efficiency of Drug Development Yili L. Pritchett, Ph.D., Research Fellow, Director, Clinical Statistics, Global Statistics and Data Management, Abbott Laboratories The challenging environment for finding and developing new drugs has called for innovations. Abbott Global Pharmaceutical Research and Development (GPRD) has embraced the notion of using adaptive designs in clinical programs to enhance efficiency, especially at the stages of poof-of-concept and dose-fining. Statistics organization has played a key role in educating the concept and methods, and in promoting the usage of adaptive designs in the past 4 years. In this talk, we will first share the efforts of promoting adaptive designs as well as the usage of Bayesian statistics within Abbott GPRD. We will then present a couple different types of adaptive designs that were successfully implemented and achieved tangible results. Finally, the process that we created to enable the implementation of adaptive designs will also be shared. 12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
ADAPTIVE DESIGN FOR VARIOuS PHASES 1:50 Chairperson's Remarks David Manner, Ph.D., Group Leader, Endocrine Exploratory and Program Medical Statistics, Eli Lilly
2:25 Design and Trial Operational Considerations for a Phase II Two-Stage Adaptive Trial Weili He, Ph.D., Associate Director, Clinical Biostatistics, Merck Sharp & Dohme Corp. We design a two-stage adaptive design for the purposes of proof-of-concept and obtaining preliminary dose response information for a new chemical entity. Patients will be randomized to receive a high dose of test drug, placebo, and an active control during Stage I. During Stage II, a lower dose of test drug will be added in addition to the treatment arms in Stage I. Since the trial serves multiple purposes, we consider several design issues. 2:55 A Bayesian Adaptive Design Case Study in a Phase III Cancer Trial Jason Connor, Ph.D., Statistical Scientist, Berry Consultants This example of a Bayesian adaptive design for a phase III oncology trial incorporates longitudinal modeling of patient outcomes and predictive probabilities. The primary outcome is overall survival and the final analysis is a standard log-rank test. Meanwhile a Bayesian machinery is used ‘behind the curtain' to select the optimal sample size based upon accruing information at predefined sample size selection analyses. At each interim analysis, the adaptive design considers differences in progression-free survival and uses this to predict future overall survival differences based upon an internal and constantly updated longitudinal model. The sample size algorithm is based on two predictive probabilities. 3:25 Networking Refreshment Break in the Exhibit Hall with Poster Viewing 4:00 Case Study: Dose-Finding Studies in Diabetes Drug Development David Manner, Ph.D., Group Leader, Endocrine Exploratory and Program Medical Statistics, Eli Lilly In drug development, researchers have many decisions to make regarding the clinical plan to adequately assess the efficacy and safety of a new compound for patients and to optimize commercial outcome. Specifically, in Phase 2 and Phase 3 clinical trials, design parameters and decision criteria should be chosen with the overall clinical plan in mind. For example, in Phase 2 studies, a researcher should consider the impact on phase 3 of design parameters such as of the number of doses, number of patients, duration of study, and whether an adaptive or fixed design is used. A simulation study will be presented to examine the impact of these decisions for an experimental compound in diabetes drug development. 4:30 Panel Discussion: What it Takes to Run a Successful Adaptive Trial 5:00 Interactive Breakout Discussion Groups Topic: How many doses do you need in a dose ranging study? Topic: Adaptive trials in oncology Topic: Clinical IVR/IWR systems in Adaptive Clinical Trials 6:00-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing
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