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Applying justice in clinical trials for diverse populations

Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA, tilburtj{at}cc.nih.gov, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA

Jean G. Ford

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, Evidence-based Practice Center, Johns Hopkins University, Baltimore, MD, USA

Mollie W. Howerton

Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA

Tiffany L. Gary

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA

Gabriel Y. Lai

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

Shari Bolen

Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA

Charles Baffi

Cancer Prevention Fellowship Program, National Cancer Institute, Bethesda, MD, USA

Renee F. Wilson

Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Evidence-based Practice Center, Johns Hopkins University, Baltimore, MD, USA

Teerath Peter Tanpitukpongse

Evidence-based Practice Center, Johns Hopkins University, Baltimore, MD, USA

Neil R. Powe

Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Evidence-based Practice Center, Johns Hopkins University, Baltimore, MD, USA, Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD, USA

Eric B. Bass

Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, Evidence-based Practice Center, Johns Hopkins University, Baltimore, MD, USA, Urban Health Institute, Johns Hopkins University, Baltimore, MD, USA

Jeremy Sugarman

Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA

Background Considerable attention has focused on increasing clinical trial participation for members of "underrepresented groups". However, doing so involves clarifying how to meet the demands of justice, or fairness, which provides the ethical mandate to enhance broad trial representation.

Purpose To examine the ethical principle of justice as it applies to recruiting diverse populations to clinical trials representation.

Methods In this paper, we analyse the conceptual and practical challenges in applying the principle of justice to clinical trials representation.

Results Different facets of justice include demands for both fair outcomes and fair processes. Including both of these facets in clinical trials policy should not only promote access to trials, but also help to provide a framework to improve fairness in representation in clinical trials. Efforts to evaluate recruitment of representation should include outcome and process measures.

Limitations The suggestions offered based on this conceptual analysis need to be tested empirically.

Conclusions Those involved in the design, conduct and oversight of clinical trials should consider all of the facets of justice when assessing representation in clinical trials and attempt to balance fair access to trials with a fair process that may require protection from being unduly pressured to participate. Clinical Trials 2007; 4: 264—269; http://ctj.sagepub.com

Clinical Trials, Vol. 4, No. 3, 264-269 (2007)
DOI: 10.1177/1740774507079440


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