Comparison of the three designs for evaluating treatments assuming 50% 14-d survival probability in the standard care group.

<p>The designs compared are a conventional RCT without interim analysis (red), a group SRCT with interim analyses for every 25 patients with 14-d outcomes (green), and an MSA (blue). (A) Probability of concluding an experimental treatment is effective (defined as a treatment where the probability of surviving to day 14 is greater than 0.5). (B) Mean time to rolling out or discarding the treatment (solid and dotted lines) and associated 5th and 95th percentiles (shaded regions). In the MSA, a phase III single-arm confirmation study may be performed following roll-out. Time to reach a conclusion from this study is shown by the dashed line. (C) Probability that an RCT is performed in the MSA. (D) Mean number of deaths amongst patients enrolled for the three study designs. (E) Mean percentage reduction in mortality amongst EVD cases in the wider population over 100 d following the start of evaluation compared with no treatment scenarios. Results are shown for two scenarios: one scenario assumes 100 new cases per day (solid lines and filled circles), and the other assumes exponential epidemic growth (dashed lines and open circles). Treatment is assumed to be made available immediately to all new EVD cases after the roll-out time. (F) Mean number of patients starting treatment each day under the scenarios in (E) assuming that the experimental treatment increases 14-d survival probability to 80%.</p

Map showing the distribution of 110 research sites as of July 2014.

<p>Map showing the distribution of 110 research sites as of July 2014.</p

Additional file 2: of Global health trials methodological research agenda: results from a priority setting exercise

Categories for Survey Round 2 v1.0. (XLSX 96 kb

Demographic and clinical features at enrolment.

<p>Demographic and clinical features at enrolment.</p

Treatment and clinical progression during admission.

<p>Treatment and clinical progression during admission.</p

CONSORT Flow Diagram.

<p>Consort diagram of patients eligible, recruited, numbers followed up and included in analysis.</p

Patient screening and enrolment.

<p>*One patient did not give consent. One patient was not competent to give consent, and a suitable proxy to provide consent could not be identified within inclusion time limits. **Two patients who died within 48 h of admission were excluded from the primary outcome analysis, as specified in the protocol.</p

Baseline demographic and clinical characteristics of trial population.

<p>Baseline demographic and clinical characteristics of trial population.</p