Platform Trial Designs in Drug Development (eBook, PDF)

Umbrella Trials and Basket Trials
Redaktion: Antonijevic, Zoran; Beckman, Robert A.

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 322
• Erscheinungstermin: 7. Dezember 2018
• Englisch
• ISBN-13: 9781351683937
• Artikelnr.: 54785768

Autorenporträt

Zoran Antonijevic is Owner and Consultant of Z-Adaptive Design. He held executive positions in Pharmaceutical Companies and CROs and has designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. He has authored numerous papers and scientific presentations and edited Optimization of Pharmaceutical R&D Programs and Portfolios. Robert Beckman is Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics at the Lombardi Comprehensive Cancer Center and the Innovation Center of Biomedical Informatics, Georgetown University Medical Center. He has played significant leadership roles in developing new oncology clinical research groups at four pharmaceutical companies, while co-inventing several novel clinical and statistical development strategies. His versatile publication record comprises more than 250 contributions ranging from computational chemistry to clinical oncology. The editors are past and current chairs of the Drug Information Association Adaptive Design Scientific Working Group, an international group of over 200 statisticians focused on novel clinical study designs and their role in bringing new medicines to patients.

Inhaltsangabe

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