This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (1) Google Scholar Articles by Cook, D. Articles by Roberts, I. PubMed PubMed Citation Articles by Cook, D. Articles by Roberts, I. Social Bookmarking                   What's this?

Randomized Trials in Vulnerable Populations

Department of Medicine, McMaster University, Department of Clinical Epidemiology & Biostatistics, McMaster University, debcook{at}mcmaster.ca

Anne Moore-Cox

Department of Clinical Epidemiology & Biostatistics, McMaster University, Population Health Research Institute McMaster University, Hamilton, Ontario, Canada

Denis Xavier

Population Health Research Institute McMaster University, Hamilton, Ontario, Canada, Department of Pharmacology and Division of Clinical Trials, St. John's Medical College, Bangalore, India

François Lauzier

Department of Medicine, Université Laval, Québec City, Québec, Canada

Ian Roberts

London School of Hygiene & Tropical Medicine, London, UK

Many persons enrolled in clinical trials can be considered vulnerable, and such trials often raise concerns because of the diminished ability of vulnerable persons to consider and protect their own interests. However, this research is necessary to answer important questions, such as which interventions are effective, which have no impact, and which do more harm than good. In this article, we identified six specific challenges associated with randomized clinical trials in vulnerable populations and have suggested several potential solutions to overcome these challenges. First addressed were macro issues, such as the scope of the problem, and research capacity in terms of funding and investigators. Next, we have addressed research ethics review, informed consent, regulatory hurdles, and serious adverse event reporting. As clinical trials are expanding globally, all stakeholders (investigators, granting agencies, REBs, DSMBs, regulatory bodies, universities, hospitals, clinicians, patients, and family members) should be aware of the challenges we have outlined, and work collaboratively toward effective solutions that improve the quality, quantity, safety, and relevance of clinical trials for vulnerable persons around the world. Clinical Trials 2008; 5: 61—69. http://ctj.sagepub.com

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				D. Cook MD, F. Lauzier MD, M. G. Rocha MD, M. J. Sayles RN, and S. Finfer MD Serious adverse events in academic critical care research Can. Med. Assoc. J., April 22, 2008; 178(9): 1181 - 1184. [Full Text] [PDF]