Difference between revisions of "Adaptive Design SWG"

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| Vice-Chair || Cristiana Mayer || Johnson & Johnson || [mailto:cmayer@its.jnj.com cmayer@its.jnj.com]
 
| Vice-Chair || Cristiana Mayer || Johnson & Johnson || [mailto:cmayer@its.jnj.com cmayer@its.jnj.com]
 
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|Secretary  || Rui Tang || Servier || [mailto:sammi.tang@servier.com sammi.tang@servier.com]
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|Secretary  || Rui (Sammi) Tang || Servier || [mailto:sammi.tang@servier.com sammi.tang@servier.com]
 
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|Secretary || Yi Liu || Nektar || [mailto:yliu@nektar.com yliu@nektar.com ]
 
|Secretary || Yi Liu || Nektar || [mailto:yliu@nektar.com yliu@nektar.com ]

Latest revision as of 15:54, 10 June 2019


DIA Adaptive Design Scientific Working Group Mission

Ensure that adaptive designs, when applied appropriately, are an accepted and broadly utilized approach that leads to improved drug development and patient care.

Contact

Role Name Organization E-mail
Chair Robert A. Beckman Georgetown University Medical Center robert.beckman@georgetown.edu
Vice-Chair Cristiana Mayer Johnson & Johnson cmayer@its.jnj.com
Secretary Rui (Sammi) Tang Servier sammi.tang@servier.com
Secretary Yi Liu Nektar yliu@nektar.com
Past Chair Zoran Antonijevic Z Adaptive Design zoranton@yahoo.com

Key Accomplishments

Public workshops and major educational events

Books

Date Editors Title Publisher
2018 Antonijevic Z.; Beckman R.A. Platform Trials in Drug Development: Umbrella Trials and Basket Trials. CRC Press, Taylor and Francis Group
2015 Patel, N.; Ankolekar, S. Dynamically Optimizing Budget Allocation for Phase 3 Drug Development Portfolios Incorporating Uncertainty in the Pipeline. Springer
2014 He W.; Pinheiro J.; Kuznetsova O. Practical Considerations for Adaptive Trial Design and Implementation. Springer
2014 Antonijevic Z. Optimization of Pharmaceutical R & D Programs and Portfolios - Design and Investment Strategy. Springer

Publications

Full references: File:ADWGreferences.docx, Bibtex file
Date Author Title Journal
2016 Methodological Extensions of Phase 2 Trial Designs Based on Program-Level Considerations: Further Development of a Case Study in Neuropathic Pain Therapeutic Innovation & Regulatory Science
2016 Adaptive Informational Design of Confirmatory Phase III Trials with an Uncertain Biomarker Effect to Improve the Probability of Success Statistics in Biopharmaceutical Research
2016 DIA’s Adaptive Design Scientific Working Group (ADSWG)Best Practices Case Studies for “Less Well-understood” Adaptive Designs Therapeutic Innovation & Regulatory Science
2016 Addressing Challenges and Opportunities of “Less Well-Understood” Adaptive Designs Therapeutic Innovation & Regulatory Science
2016 Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study Statistics in Biopharmaceutical Research
2015 CBER’s Experience With Adaptive Design Clinical Trials Therapeutic Innovation & Regulatory Science
2015 Effective Drug Supply for Adaptive Clinical Trials: Recommendations by the DIA Adaptive Design Scientific Working Group Drug Supply Subteam Therapeutic Innovation & Regulatory Science
2015 Sample Size Re-estimation Designs In Confirmatory Clinical Trials—Current State, Statistical Considerations, and Practical Guidance Statistics in Biopharmaceutical Research
2014 Adaptive Design Results of 2012 Survey on Perception and Use Therapeutic Innovation & Regulatory Science
2013 Improving Oncology Clinical Programs by Use of Innovative Designs and Comparing Them via Simulations Therapeutic Innovation & Regulatory Science
2013 Optimizing Drug Development Programs Type 2 Diabetes Case Study Drug Information Journal
2013 Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials Therapeutic Innovation & Regulatory Science
2013 Improving Oncology Clinical Programs by Use of Innovative Designs and Comparing Them via Simulations Therapeutic Innovation & Regulatory Science
2013 A mathematical model for maximizing the value of phase 3 drug development portfolios incorporating budget constraints and risk Statistics in Medicine
2012 Designing Phase 2 Trials Based on Program-Level Considerations: A Case Study for Neuropathic Pain Drug Information Journal
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 in Biopharmaceutical Research
2010 Impact of Dose Selection Strategies Used in Phase II on the Probability of Success in Phase III pdf
2010 A Simulation Study to Compare New Adaptive Dose–Ranging Designs Statistics in Biopharmaceutical Research
2010 Data Monitoring in Adaptive Dose-Ranging Trials Statistics in Biopharmaceutical Research
2010 Viewpoints on the FDA Draft Adaptive Designs Guidance from the PhRMA Working Group Journal of Biopharmaceutical Statistics
2009 Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development Drug Information Association Journal
2007 Innovative Approaches for Designing and Analyzing Adaptive Dose-Ranging Trials Journal of Biopharmaceutical Statistics
2007 Adaptive Designs in Clinical Drug Development: Opportunities, Challenges, and Scope Reflections Following PhRMA's November 2006 Workshop Journal of Biopharmaceutical Statistics
2007 Guest Editorial—Statistical Issues in Adaptive Design Methods in Clinical Trials Journal of Biopharmaceutical Statistics
2006 Adaptive Designs in Clinical Drug Development—An Executive Summary of the PhRMA Working Group Journal of Biopharmaceutical Statistics
2006 PhRMA working group on adaptive designs: Introduction to the full white paper Drug Information Journal
2006 Adaptive Designs: Terminology and Classification Drug Information Journal
2006 Sample Size Reestimation: A Review and Recommendations Drug Information Journal
2006 Adaptive Seamless Phase II/III Designs-Background, Operational Aspects, and Examples Drug Information Journal
2006 Adaptive Dose-Response Studies Drug Information Journal
2006 Implementing adaptive designs: logistical and operational considerations Drug Information Journal

Plans/Events

Date Event
05/31/2019 Core Team meeting
05/31/2019 Core Team meeting
Date 1 DIA ADSWG during the ASA /JSM in Baltimore on Wednesday 8/2/17 from 5-6:30 PM at Key Ballroom 6 in the Hilton Baltimore
Date 2 Adaptive Design in Clinical Trials: When and How to Apply
Date 3 2016 Trends and Innovations in Clinical Trial Statistics
Date 4 DIA/FDA Statistics 2016 Forum
Date 5 February conference on adaptive designs and Bayesian statistics, Washington, DC, US

Workstreams/Subgroups

Name Status Lead Documentation Comments
ADSWG Website New John Loewy Successful launch in 2016; Determine Best Practices 2017
ADSWG Website New John Loewy Successful launch in 2016; Determine Best Practices 2017
Adaptive Dose Individualization Subteam (ADONIS) Continuing David Norris/ Maha Karnoub Launched August 2017. Key accomplishments: (1) JSM2018 Topic-Contributed Session Proposal; (2) Oct 2018 submitted Public Comment on FDA Draft Guidance on Expansion Cohorts in FIH Oncology Trials.
Adaptive Programs (AP) -Neur. Pain Continuing Nitin Patel Charter Finalizing 2 papers
AP-Oncology Continuing Olga Marchenko/Tom Parke Charter Finalizing a paper
Best Practices Continuing Eva Miller/ Weili He 2015 Update Has 2 workstreams; 2 papers in progress
CDRH Draft Guidance Closed Christopher Coffey Comments submitted
DIA Training on Adaptive Design Closed Sandeep Menon Delivered in September 2015
Expedited Approvals Continuing Bob Campbell / Larry Gould (BSWG) Charter Launched in 2016; finalizing manuscript on framework for modeling FDA Accelerated Approval impacts on patients
International Health New Shawn Dolley Highly Efficient Trials for Developing Countries
KoL Series Continuing Cong Chen/ Sandeep Menon/ John Loewy 2017 Update
Medical Outreach New Deborah Wenkert, Collaboration with Bayesian Scientific Working Group (BSWG); Educate medical professionals on value and basic principles of Adaptive Designs
NEED Subgroup (Nature and Extent of Evidence required for regulatory Decisions for rare diseases) Continuing Sammi Tang, Mercedeh Ghadessi and Joey Zhou Successful launch in 2014; Manuscript on historical controls near completion; other manuscripts planned; focus group on case studies launched
Pediatric White Paper Continuing Jasmina Savic Joint effort with DIA BSWG, and Regulatory Affairs Community; developing slowly
Publicity Generating Continuing Tom Laage Charter Paper submitted
Precision Medicine Continuing Sandeep Menon / Zhaoling Meng Charter Paper in progress; developing slowly
Simulations New/Continuing Cristiana Mayer/ Inna Perevozskaya Charter Kicked-off in 2015
AP Small Populations Continuing Bob Beckman/ Cong Chen 2015 Update Has 5 workstreams; 4 papers submitted; more under development. Comments on rare diseases guidance submitted
SSR Closed Yili Pritchett Paper Accepted in 2015
Supplies Closed Nancy Burnham Paper Published in 2015
Survey drugs and biologics New/Continuing Alan Hartford Charter
Survey-Devices New Caroline Morgan/ Ted Lystig Charter

Keywords

Adaptive design, education, advocacy


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