HOW RCTs WORK
Q: This process assigns participants to groups by chance to reduce bias.
What is randomization
According to Angell, when are placebos ethically permissible?
What is only when no effective treatment exists
Define clinical equipoise precisely
What is genuine uncertainty within the medical community about which treatment is better
Hellman argues that doctors in RCTs are forced to play these two roles at once.
What are physician and scientist
A patient is randomly assigned a placebo even though a treatment exists. What ethical principle is most at risk?
What is Beneficence
RCTs are considered the “_____ standard” of clinical research.
What is the gold standard
What standard does Brody use to evaluate placebo use?
what is the normative standard (what patients should receive)
Why does equipoise solve the ethical problem (in theory)?
What is: Because no patient is knowingly given inferior treatment
Hellman’s view is based more on this ethical theory: focusing on duties.
What is deontology?
A patient signs a consent form but doesn’t understand the risks. Is this true informed consent?
what is "No"
Why are RCTs considered the “gold standard” of research?
What is: Because they reduce bias and produce reliable evidence
Contrast Angell and Brody in ONE sentence.
What is: Angell demands global best treatment, while Brody allows context-sensitive ethical evaluation
Why do the Hellmans think true equipoise is rare?
What is: Physicians usually have beliefs or expectations about treatment effectiveness
What is the main conflict in RCTs according to Hellman?
What is patient care vs scientific research
A doctor believes Treatment A is better but still enrolls a patient in an RCT. What’s the ethical issue?
what is not acting in the patient’s best interest
This design prevents both researchers and participants from knowing who receives treatment (prevents bias)
What is a double-blind design
Why does Angell reject placebo trials in developing countries?
what is: Because they exploit populations by denying known effective treatment
What assumption does the “RCTs are ethical because equipoise exists” argument rely on?
What is: That equipoise always exists at the start of trials
When does Hellman say RCTs might be acceptable?
What is when clinical equipoise exists
A study is done in a poor country because treatment is unavailable there. What concern does this raise?
What is exploitation
Name TWO key components required for a valid RCT.
What are randomization, control group, experimental group, double-blind design, or significance testing
According to Brody, why is “what patients would normally receive” not enough?
What is: Because ethics depends on what they SHOULD receive, not current inequality
Give ONE reason why even perceived equipoise might be ethically unstable DURING a trial
What is: Early results may suggest one treatment is better, making continued randomization unethical
Complete the argument:
“A physician must act in the patient’s best interest; RCTs do not do this; therefore…”
What is RCTs are not morally permissible
Why might an RCT still be justified even if some patients don’t get the best treatment?
What is it can produce knowledge that helps many future patients