The Use of External Controls in FDA Regulatory Decision Making

Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review

(2019) Sarah Goring et al.   BMJ Open

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

(2019) Christina Mack et al.   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

Comparison of Propensity Score Methods and Covariate Adjustment

(2017) Markus C. Elze et al.   JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Evaluating interventions for Ebola: The need for randomized trials

(2016) Thomas R Fleming et al.   Clinical Trials

Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

(2016) Anthony J Hatswell et al.   BMJ Open

Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs

(2012) Frank J. Sasinowski   DRUG INFORMATION JOURNAL

Historical control monotherapy design in the treatment of epilepsy

(2010) Jacqueline A. French et al.   EPILEPSIA