Terminating clinical trials without sufficient subjects

• Published in: Journal of medical ethics Vol. 38; no. 7; pp. 413 - 416
• Main Authors: Damen, Lianne, van Agt, Frans, de Boo, Theo, Huysmans, Frans
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and Institute of Medical Ethics 01.07.2012; BMJ Publishing Group; BMJ Publishing Group Ltd; BMJ Publishing Group LTD
• Subjects: Biomedical Research - ethics; Biomedical Research - statistics & numerical data; Clinical trials; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Clinical Trials as Topic - statistics & numerical data; Company business management; Ethics; Ethics committees; ethics committees/consultation; Experimentation; human experimentation; Humans; Informed consent; Investigational therapies; Logistic regression; Management; Medical research; Patient Selection; Pharmaceutical industry; Pharmaceutical preparations; Research Design - standards; Research Design - statistics & numerical data; Research ethics; Research studies; Research Subjects; scientific research; Strategic aspects; Netherlands
• ISSN: 0306-6800; 1473-4257; 1473-4257
• DOI: 10.1136/medethics-2011-100020

Medical research involving human subjects can be risky and burdensome. Therefore, such research must be reviewed and approved by a Research Ethics Committee (REC). To guarantee the safety of the subjects, it is very important that these studies be conducted in accordance with the approved protocol. An important issue in this respect is whether studies include the requisite number of subjects based on the research question. The research question is unlikely to be answered reliably if the requisite number of subjects is not met. In such cases, subjects are exposed to unnecessary risks and burdens. In this descriptive study, the authors evaluated how frequently studies are completed with the required number of subjects. Moreover, the authors identified the characteristics of research that does and does not include the required number of subjects. The results of this study show that a considerable proportion of studies (41/107) were terminated although they failed to recruit a sufficient number of subjects. Furthermore, the authors found that investigator-initiated studies have significantly (p=0.028) more problems in recruiting the requisite number of subjects than studies initiated by pharmaceutical companies. Potential solutions are discussed to reduce the number of studies that do not include a sufficient number of subjects.