Clinical trials : journal of the Society for Clinical Trials
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The cluster-randomized trial is the methodology of choice for evaluating interventions administered at the group level such as public health and healthcare quality improvement interventions. Because of unique features of this design, it can be difficult to apply standard research ethics guidelines to cluster-randomized trials. The Ottawa Statement on the Ethical Design and Conduct of Cluster-Randomized Trials provides researchers and research ethics committees with comprehensive guidance on the ethical design, conduct and review of cluster-randomized trials. The Ottawa Statement supplements current national and international research ethics guidelines with guidance that is specific to cluster-randomized trials. In a recently published commentary, three examples drawn from the ClinicalTrials.gov registry were used to illustrate challenges associated with the cluster-randomized trial design. The commentary argued that the Ottawa Statement fails to provide comprehensive ethical guidance. In this article, we illustrate the application of the Ottawa Statement to the three trials. We challenge the conclusions reached in the commentary by demonstrating that an ethical analysis requires complete information. We correct some misperceptions about the cluster-randomized trial design. ⋯ The Ottawa Statement does provide a useful framework for the ethical design, review and conduct of cluster-randomized trials.
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Randomized Controlled Trial
Alignment of site versus adjudication committee-based diagnosis with patient outcomes: Insights from the Providing Rapid Out of Hospital Acute Cardiovascular Treatment 3 trial.
Adjudication by an adjudication committee in clinical trials plays an important role in the assessment of outcomes. Controversy exists regarding the utility of adjudication committee versus site-based assessments and their relationship to subsequent clinical events. ⋯ Despite substantial agreement between the diagnosis of emergency department physicians and adjudication committee, in the subgroup of patients where there was disagreement, there was significantly worse short-term and long-term mortality.
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The index case of the Ebola virus disease epidemic in West Africa is believed to have originated in Guinea. By June 2014, Guinea, Liberia, and Sierra Leone were in the midst of a full-blown and complex global health emergency. The devastating effects of this Ebola epidemic in West Africa put the global health response in acute focus for urgent international interventions. ⋯ As a follow-up to the global response, in November 2014, the Government of Liberia and the US Government signed an agreement to form a research partnership to investigate Ebola and to assess intervention strategies for treating, controlling, and preventing the disease in Liberia. This agreement led to the establishment of the Joint Liberia-US Partnership for Research on Ebola Virus in Liberia as the beginning of a long-term collaborative partnership in clinical research between the two countries. In this article, we discuss the methodology and related challenges associated with the implementation of the Ebola vaccines clinical trial, based on a double-blinded randomized controlled trial, in Liberia.