Randomised Controlled Trials Flashcards
What is efficacy?
The ability of a health care intervention to improve the health of a defined group under specific conditions
What is safety?
The ability of a health care intervention not to harm a defined group under specific conditions
Clinical trials must be …….. , ……. , ……
Reproducible, controlled and fair
How many phases are there when evaluating drugs and interventions?
Pre-clinical phase, Phase 1 , Phase 2, Phase 3, Phase 4
Why is it advantageous to randomise clinical trials?
It minimises allocation bias and minimises confounding (groups are likely to be similar by chance)
Why do you pre-define the outcomes of a RCT?
- To prevent data dredging
- So there is a protocol for data collection
- So there is agreed criteria for measurement and assessment of outcomes
What are the types of outcomes in RCT’s?
Pathophysiological, clinically defined and patient focused
What are primary outcomes used in?
The sample size calculation
What is the disadvantages of a open label study?
It may lead to alteration in behaviour
It may cause the non-treatment effect. The clinician may alter the treatment, care and interest of the patient
It may lead to measurement bias. The investigator may alter their approach to measurements and assessment
When may blinding be difficult?
- Surgical procedures
- Psychotherapy I.e antidepressants
- Alternative vs Western medicine
- Lifestyle interventions
- Prevention programmes
What are the ethical implications of using a placebo?
It is a form of deception so it is essential people are aware they may receive a placebo
What is “As-treated” analysis?
It is analysis that analyses all who completed the follow-up and completed their treatment. It may lead to selection bias and confounding
What is “intention-to-treat” analysis? And why is it advantageous?
It is analysis of the original allocation to treatment groups. It is advantageous as it is similar to real life-> people don’t always follow treatments.
What is a clinical trial?
Any form of planned experiment which involves patients and is designed to elucidate the most appropriate method of future patient ps with a given medical condition.
