Case Studies
Who was the plaintiff in Stewart v. Cleveland Clinic?
Mr. Daniel Klais
Which ethical pillar supports the patient's right to choose their treatment?
Autonomy
In which phase of clinical trials is safety first tested in humans?
Phase 1
What is the process of informing patients about risks and benefits before a trial called?
Informed consent
Which physician is credited with introducing handwashing as a medical practice?
Ignaz Semmelweis
Which experimental treatment did Abigail Burroughs seek access to?
Erbitux
The principle of "do no harm" relates to which ethical pillar?
Nonmaleficence
During which phase is the effectiveness of a drug tested on a larger group of patients?
Phase 2
True or False: Patients have a constitutional right to access investigational drugs outside of FDA approval.
False
What 1902 law established safety standards for biological products in response to tainted vaccines?
The Biologics Control Act
What was the main argument of the Abigail Alliance in their case?
Terminally ill patients should have access to drugs that passed Phase 1 safety trials.
What ethical principle involves acting in the best interest of the patient?
Beneficence
What is the main focus of Phase 3 in clinical trials?
Confirming effectiveness and monitoring adverse reactions.
Which case emphasized the need for thorough informed consent in clinical trials?
Stewart v. Cleveland Clinic
Which act, passed in 1938, first required drug safety testing before marketing?
The Federal Food, Drug, and Cosmetic Act
What was the outcome of Stewart v. Cleveland Clinic regarding informed consent?
The court ruled that informed consent requires full disclosure of risks and alternatives.
Which ethical pillar is focused on fairness and equal access to care?
Justice
Which phase takes place after FDA approval to monitor long-term effects?
Phase 4
What was the Abigail Alliance’s main goal in their case against the FDA?
To allow terminally ill patients access to experimental drugs after Phase 1 trials.
What was the first state to require pharmacists to be licensed in the U.S.?
South Carolina
Which act was passed in 2018 to support terminally ill patients' access to experimental treatments?
The Right-to-Try Act
Which ethical pillar was most challenged in Abigail Alliance v. Eschenbach?
Patient autonomy
How many years do clinical trials typically take from Phase 1 to FDA approval?
6-7 years
What ethical and legal issue does the Right-to-Try Act primarily address?
Allowing terminally ill patients access to investigational treatments.
What amendment in 1962 required both safety and efficacy evidence for FDA drug approval?
The Kefauver-Harris Amendment