Ethical Issues in the Development of Oncology Drugs – Hematology & Oncology

Professor STREAM Research Group Director, Biomedical Ethics Unit Department of Social Studies of Medicine McGill University Montreal, Quebec H&O What are some ethical concerns regarding the typical design of clinical trials in oncology? JK The risk/benefit ratio is an important concern. When treating patients with an unproven intervention, it is essential to ensure that the risks and burdens are reasonably well-understood and that the prospect of benefit, either directly to the patient or through scientific advancement, is sufficient to redeem them. Patients who participate in clinical trials may need to undergo research procedures, such as tumor biopsies and extra imaging, as well as additional clinic visits. These are all burdensome, particularly for patients who are sick. Another concern is fair subject selection. The population enrolled in a clinical trial should be consistent with the patients who will receive treatment with the drug, in terms of age, sex, ethnicity, and other f

H&O What are some ethical concerns regarding the typical design of clinical trials in oncology? JK The risk/benefit ratio is an important concern. When treating patients with an unproven intervention, it is essential to ensure that the risks and burdens are reasonably well-understood and that the prospect of benefit, either directly to the patient or through scientific advancement, is sufficient to redeem them. Patients who participate in clinical trials may need to undergo research procedures, such as tumor biopsies and extra imaging, as well as additional clinic visits. These are all burdens

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