4 ms·
That presents massive ethical issues. One would have to knowingly not give subjects a drug that we know helps them (i.e., the current standard of care).
by Locke1689 14y ago
That presents massive ethical issues. One would have to knowingly not give subjects a drug that we know helps them (i.e., the current standard of care).
- DigitalJack 14y agoThese issues are already present. You already know that some population of the participants are getting a placebo. You don't know which ones, which possibly dulls the anguish you might feel over it. I think at best you could say it would amplify already present ethical issues.
- Locke1689 14y agoThe "placebo" mostly is the current standard of care in many cases.
- starpilot 14y agoThere 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.