CRP 101 Lecture 7

Question 1

clinical trial classifications (5)

Answer 1

-prevention
-diagnostic
-quality of life
-compassion
-treatement

Question 2

use of placebo

Answer 2

inactive substance or treatement given to patients to simulate active substance. control for the reaction participants may have to an intervention and beliefs about its effects
-must be scientifically justified and not compromise the safety or health of participants

Question 3

crossover design

Answer 3

all subjects tested in all conditions, less unsystematic variability, more powerful, less sources of error. Requires repeated testing. more statistical power, each person serves as their own control, not comparing different groups of ppl

Question 4

parallel design

Answer 4

each participant only gets one treatement or condition. variability from sampling error or experimenta conditions. No effects from repeted testing. Some interventions such as surgery can only be done once. drug with long half lives. larger samle size needed.

Question 5

interim analysis

Answer 5

-ethical and business (cost)
-is one arm significanly better than another, and CT can be ended
-if one arm is better, can save cost of recruiting more ppl
-stopping points need to be defined ahead of time

Question 6

data safety monitoring boards

Answer 6

-generaly for large, multicentre studies for treatements for prolonging life or reducing risk of major adverse health conditions. Compare rates of mortality or major morbidity.
-for high risk, invasve CTs
-vulnerable population
-extreme end points

Question 7

single arm

Answer 7

-early drug development
-no standard of care treatment
-serious diseases

Question 8

master protocol studies

Answer 8

-multiple sub-studies, diff. objectives. Evaluate multiple interventions or muliple diseases.

Question 9

decentralized studies

Answer 9

-telemedicine,mobile/local healthcare provideers, mobile technology
-recruit participants anywhere
-frequent or continuous data collection
-reduce participant burden