Platform Trial Designs in Drug Development - Umbrella Trials and Basket Trials

List of contents

I. Overview of Platform Clinical TrialsIntroductionRobert A. Beckman and Zoran AntonijevicI-SPY2: Unlocking the potential of the platform trialLaura Esserman, Nola Hylton, Smita Asare, Christina Yau, Doug Yee, Angie Demichele, Jane Perlmutter, Fraser Symmans, Laura van’t Veer, Jeff Matthews, Don Berry, and Anna BarkerThe challenges with Multi-arm targeted therapy trialsRyan J. Sullivan and Keith Flaherty. Basket trials at the confirmatory stageRobert A. Beckman and Cong ChenHarnessing Real World Data to Inform Platform Trial DesignDaphne A. Guinn, Subha Madhavan, and Robert A. BeckmanImpact of Platform Trials on Pharmaceutical FrameworksZoran Antonijevic, Edward Mills, Jonas Häggström, and Kristian Thorlund. II. StakeholdersFriends of Cancer Research Perspective on Platform trialsJeff D. Allen, Madison Wempe, Ryan Hohman, and Ellen Sigal Regulatory and Policy aspects of Platform trialsRasika Kalamegham, Ramzi Dagher, and Peter Honig Multi-arm, multi-drug trials from a reimbursement perspectiveAnja Schiel, and Olivier CollignonHighly Efficient Clinical Trials: A resource-saving solution for global healthEdward Mills, J

Summary

Drug development sponsors cannot run individual trials for all products in all indications. This results in missed opportunities. Clinical trial programs known as “basket” and “umbrella” have demonstrated that multi-product, multi-indication trials can be efficient and feasible.

Product details

• Authors: Zoran Beckman Antonijevic
• Assisted by: Zoran Antonijevic (Editor), Antonijevic Zoran (Editor), Robert A. Beckman (Editor)
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 21.11.2018
• EAN: 9781138052451
• ISBN: 978-1-138-05245-1
• No. of pages: 322
• Series: Chapman & Hall/CRC Biostatistics Series
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Pharmacy; MATHEMATICS / Probability & Statistics / General, MEDICAL / Pharmacology, MEDICAL / Biostatistics, Pharmacology, Clinical Trials