Table 1

During the 2014–2015 outbreak, were these conditions consistent (√) or inconsistent (–) with placebo individually randomised controlled trials (placebo iRCT), active iRCT and stepped-wedge/ring-vaccination designs of efficacy studies for candidate Ebola vaccines?

Placebo iRCTActive iRCTStepped-wedge or ring-vaccination trial
1. General
  1. The study intervention is needed urgently for many people.

  • b. No study assignment involves a procedure that is expected to actively harm any participant more than it directly benefits her.

  1. No intervention for the condition studied is approved (and available to candidate participants).

2. Participant access to study intervention
  1. All participants receive the study intervention during the trial—except ones who die or get infected before the intervention reaches them.

  • b. All participants receive the study intervention during the trial or shortly thereafter—except ones who die or get infected before the intervention reaches them.

  • c. For any prespecified level of statistical power to detect a given effect size, typically the number of participants who die or get infected before the study intervention reaches them is minimal.

3. Impact on participants' prospects
  1. Participation improves medical prospects for each participant (both before and immediately after randomisation) more than any alternative available outside the trial.

  • b. Participation improves medical prospects for each participant (both before and immediately after randomisation) more than any alternative, including even alternatives that compromise trial efficiency or validity.

  • c. Participation improves medical prospects for each participant (both before and immediately after randomisation), making their prospects better than those of relevant non-participants.

  • d. Equipoise (understood here as equal medical prospects in all arms immediately after randomisation) obtains.

  • e. In no trial arm do the typical participants have grim medical prospects (immediately after randomisation).

  • For simplicity, the table assumes trials with two equally sized arms.