Author:
Beckman Robert A.,Natanegara Fanni,Singh Pritibha,Cooner Freda,Antonijevic Zoran,Liu Yi,Mayer Cristiana,Price Karen,Tang Rui,Xia Amy,Apostolaros Maria,Granville Courtney,Michaels Debra
Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmacology,General Medicine
Reference5 articles.
1. Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products: Guidance for Industry (FDA, 2020): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interacting-fda-complex-innovative-trial-designs-drugs-and-biological-products
2. Woodcock, J. & LaVange, L. M. Master protocols to study multiple therapies, multiple diseases, or both. N. Engl. J. Med. 377, 62–70 (2017).
3. Collignon, O. et al. Current statistical considerations and regulatory perspectives on the planning of confirmatory basket, umbrella, and platform trials. Clin. Pharmacol. Ther. 107, 1059–1067 (2020).
4. Ghadessi, M. et al. A roadmap to using historical controls in clinical trials—by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG). Orphanet J. Rare Dis. 15, 69 (2020).
5. Antonijevic, Z. et al. Patient benefits from innovative designs in rare diseases, in Rare Disease Drug Development: Clinical, Scientific, Patient, and Caregiver Perspectives (ed. Huml, R. A.) 147–160 (Springer, 2021).
Cited by
7 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献