Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa?  Dr Simone Lanini, MD, Prof Alimuddin Zumla, FRCP, Prof John P A Ioannidis, MD, Antonino Di Caro, MD, Prof Sanjeev Krishna, ScD, Prof Lawrence Gostin, JD, Enrico Girardi, MD, Michel Pletschette, MD, Gino Strada, MD, Aldo Baritussio, PhD, Gina Portella, MD, Giovanni Apolone, MD, Silvio Cavuto, MSc, Roberto Satolli, MD, Prof Peter Kremsner, MD, Francesco Vairo, MD, Giuseppe Ippolito, MD  The Lancet Infectious Diseases  Volume 15, Issue 6, Pages 738-745 (June 2015) DOI: 10.1016/S1473-3099(15)70106-4 Copyright © 2015 Elsevier Ltd Terms and Conditions

Figure 1 Flowchart for selection of clinical trials enrolling patients with acute Ebola virus disease to assess efficacy or safety, or both, of new interventions Records or trial to be selected (green boxes); excluded records or trials (orange boxes); analysed trials (blue boxes). EUDRA=European Union Drug Regulatory Authorities. PACTR=Pan African Clinical Trial Registry. ICTRP=International Clinical Trials Registry Platform (WHO). The Lancet Infectious Diseases 2015 15, 738-745DOI: (10.1016/S1473-3099(15)70106-4) Copyright © 2015 Elsevier Ltd Terms and Conditions

Figure 2 Trial simulation to estimate probability of early stopping (A) Early stopping estimate at the first interim analysis (overall sample size=70). (B) Early stopping estimate at the second interim analysis (overall sample size=140). *Punctual estimate for early stopping if reported mortality in control group is equal to 10% (ie, extraordinary unexpected efficacy). †Punctual estimate for early stopping if reported mortality is equal to the a priori assumptions. The Lancet Infectious Diseases 2015 15, 738-745DOI: (10.1016/S1473-3099(15)70106-4) Copyright © 2015 Elsevier Ltd Terms and Conditions