3 ms·
There are no ethical issues. 1. Study participants are told that some of them will receive a "sham" (placebo) treatment. Participation is voluntary. 2. It is
by starpilot 14y ago
There are no ethical issues.
1. Study participants are told that some of them will receive a "sham" (placebo) treatment. Participation is voluntary.
2. It is not known whether the drug they are testing is effective or comparable to the current standard of care. Determining that is the purpose of the study.
- refurb 14y agoThis is not correct and not currently accepted policy by the FDA. Take oncology drugs for example. Let's say you come up with a great new drug to treat Non-Hodgkin's lymphoma (NHL). Currently approved drugs already are very effective, pushing overall survival to close to a decade. If you're a drug company, there is zero chance you'd get approved (by the independent IRB board who monitor ethical considerations) to run an NHL trial using a placebo. Even if patients agreed to take part in the trial, it would be unethical to deny effective treatments for a potentially fatal disease. Hence, the FDA has softer data and efficacy requirements for oncology therapies. There is no requirement for a placebo arm unless there is no currently effective treatment available.