Chapter 11 | Clinical Trials Flashcards
The United States National Institutes of Health (NIH) has stipulated seven ethical requirements to ensure that, before the trial begins, there is proper consideration of ethical issues and that the trial subjects are protected
True
Clinical trials account for at least 60% of drug development costs
True
The Seven Ethical Requirements:
Social value
Scientific validity
Fair subject selection
Informed consent
Favorable risk-benefit ratio
Independent review
Respect for human subjects
According to NIH ethical guidelines, what is the most important criteria in selecting subjects for clinical studies?
Scientific objectives.
The members of the IRB/IEC must be experts in the topic of study.
True
Which phases of clinical studies are open label and which are blinded?
Phase I and IV trials are often open label, but Phase II and III are double-blinded or at least blinded.
If it is not possible to measure the direct effects of a drug, what is used instead?
Surrogate markers such as blood pressure and cholesterol levels.
What is the name of an observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks back in time (e.g. via chart reviews) to find exposure to risk factors?
Case-control study.
Which measure of central tendency is the sum of all observations divided by the number observations?
Mean
Which measurement describes the number of new events that occur during a specified period of time in a population at risk for the event (e.g. lung infections per year)?
Incidence.
________________ is used to describe the variability of the population mean.
Standard error of the mean
What term denotes the extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring?
Validity.
What are the Kaplan-Meier analysis and Cox proportional hazards analysis?
Methods of survival analysis.
What section of a clinical paper describes subjects’ entry and exclusion criteria?
Methods
Which document sets out how a trial is to be conducted (i.e. the study’s general design and operating features)?
Protocol
