252- clinical trials

Question 1

what is therapeutic misconception

Answer 1

Research and patient care can be blended but the purpose of clinical trials is to advance knowledge not to provide patient care. Believing otherwise is referred to as the “therapeutic misconception”.

Question 2

three principles of ethics for research with humans

Answer 2

respect for persons, beneficence, justice

Question 3

Phase 1: who? sample size? procedure? Outcome

Answer 3

has been tested in animals, now being tested in healthy adults or pts with no other alternative. Small sample, dose escalation procedure. Outcomes are toxicity and pharmacokinetics

Question 4

phase 2: sample size? subjects? procedure? outcome?

Answer 4

moderate

pts w/ condition intended to treat

randomized, controlled

dz response, short term SE

Question 5

phase 3: sample size? subjects? procedure? outcome?

Answer 5

large

patients

randomized, controlled, blinded, may combine w/ other drugs

dz progression, SEs

Question 6

phase 4: sample size, subjects? procedure? outcome?

Answer 6

very large

pts receiving tx

drug given to all pts

rare SEs and those that are long-term

FDA approval required

Question 7

three parts of informed consent

Answer 7

information, comprehension, voluntariness