- COMMENT
Informing single-arm clinical trials with external controls
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$29.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Rent or buy this article
Prices vary by article type
from$1.95
to$39.95
Prices may be subject to local taxes which are calculated during checkout
Nature Reviews Drug Discovery 19, 821-822 (2020)
doi: https://doi.org/10.1038/d41573-020-00146-5
References
Grayling, M. J., Dimairo, M., Mander, A. P., Jaki, T. F. A review of perspectives on the use of randomization in phase II oncology trials. J. Natl Cancer Inst. 111, 1255–1262 (2019).
Austin, P. C. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav. Res. 46, 399–424 (2011).
Gokbuget, N. et al. Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia. Blood Cancer J. 6, e473 (2016).
Cave, A., Kurz, X. & Arlett, P. Real-world data for regulatory decision making: challenges and possible solutions for Europe. Clin. Pharmacol. Ther. 106, 36–39 (2019).
Sherman, R. E. et al. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat. Rev. Drug Discov. 16, 297–298 (2017).
Competing Interests
Medidata Solutions provides data and services related to external control arms. R. Davi and A. Chatterjee are employees of Medidata Solutions and C. J. Dawson is a contractor of Medidata Solutions.