When Context Is Hard to Come By: External Comparators and How to Use Them

Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration

(2019) Talal Hilal et al.   JAMA Oncology

Advancing a Framework for Regulatory Use of Real-World Evidence

(2018) Nancy A. Dreyer   Therapeutic Innovation & Regulatory Science

Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials

(2018) Jessica Lim et al.   Therapeutic Innovation & Regulatory Science

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics

(2018) Julia A. Beaver et al.   JAMA Oncology

Real-world treatment outcomes in patients with metastatic Merkel cell carcinoma treated with chemotherapy in the USA

(2017) C Lance Cowey et al.   Future Oncology

Multidimensional Evidence Generation and FDA Regulatory Decision Making

(2017) Jonathan P. Jarow et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Evaluation of real-world treatment outcomes in patients with distant metastatic Merkel cell carcinoma following second-line chemotherapy in Europe

(2017) Jürgen C. Becker et al.   Oncotarget

Real-World Evidence — What Is It and What Can It Tell Us?

(2016) Rachel E. Sherman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia

(2016) N Gökbuget et al.   Blood Cancer Journal