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Full-Text Articles in Arts and Humanities
Characterizing The Population In Clinical Trials: Barriers, Comparability, And Implications For Review, Charles Weijer
Characterizing The Population In Clinical Trials: Barriers, Comparability, And Implications For Review, Charles Weijer
Charles Weijer
The definition of the study population for a clinical trial via the criteria for trial eligibility has implications for the validity of the study and its applicability to clinical practice. Though issues of equity regarding the selection of subjects for research have long been a concern of ethicists, issues regarding the impact of subject selection on a trial's generalizability have only recently attracted ethical scrutiny. After a review of the history of the ethics of subject selection, I focus on three empirical questions regarding the generalizability of clinical trials. (1) What proportion of diseased populations are studied in clinical trials? …
Monitoring Clinical Research: An Obligation Unfulfilled, Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Glass, Myriam Skrutkowska
Monitoring Clinical Research: An Obligation Unfulfilled, Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Glass, Myriam Skrutkowska
Charles Weijer
The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by …