Broschiertes Buch

Platform Trial Designs in Drug Development

Umbrella Trials and Basket Trials

Herausgeber: Antonijevic, Zoran; Beckman, Robert A.

Beschreibung

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.

Autor

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.

Produktdetails

• Verlag: Chapman and Hall/CRC
• Seitenzahl: 322
• Erscheinungstermin: 18. Dezember 2020
• Englisch
• Abmessung: 234mm x 156mm x 17mm
• Gewicht: 491g
• ISBN-13: 9780367732639
• ISBN-10: 0367732637
• Artikelnr.: 69892241