Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2014 Dec 10:349:g7518.
doi: 10.1136/bmj.g7518.

Ebola virus vaccine trials: the ethical mandate for a therapeutic safety net

Affiliations

Ebola virus vaccine trials: the ethical mandate for a therapeutic safety net

Steve E Bellan et al. BMJ. .
No abstract available

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

None
Anticipated number of deaths among participants by trial arm in a hypothetical vaccine trial, with and without a treatment that reduces the case fatality rate by 70%. The therapeutic safety net reduces overall mortality and, crucially, also substantially bridges the gap between the two arms, thereby facilitating clinical equipoise. Following vaccine trial proposals, we assume that 30 participants will become infected before the trial reaches its stopping criteria. All assumptions are explained in the supplementary code (http://ebola.ici3d.org/BMJ/equipoise.R)

References

    1. Arie S. Ebola: an opportunity for a clinical trial? BMJ 2014;349:g4997. (6 August.) - PubMed
    1. Van der Graaf R, van Delden JJM. Equipoise should be amended, not abandoned. Clin Trials 2011;8:408-16. - PubMed
    1. Adebamowo C, Bah-Sow O, Binka F, Bruzzone R, Caplan A, Delfraissy JF, et al. Randomised controlled trials for Ebola: practical and ethical issues. Lancet 2014;384:1423-4. - PMC - PubMed
    1. Cohen J, Kupferschmidt K. Tough choices ahead in Ebola vaccine trials. ScienceMag 2014. http://news.sciencemag.org/africa/2014/10/tough-choices-ahead-ebola-vacc....
    1. Bah EI, Lamah M-C, Fletcher T, Jacob ST, Brett-Major DM, Sall AA, et al. Clinical presentation of patients with Ebola virus disease in Conakry, Guinea. N Engl J Med 2014; published online 5 Nov; 10.1056/NEJMoa1411249. - DOI - PubMed