10. Clinical Trials Flashcards
What is a clinical trial?
Research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans
What is the purpose of the Declaration of Helsinki (1964)?
Set of ethical principles regarding human research developed for the medical community by the World Medical Association. First document on research ethics to safeguard patients. Made voluntary consent of individuals absolutely necessary.
What is the difference between an efficacy and effectiveness clinical trial?
Efficacy study (phase 1) = controlled conditions, looking at safety, determining internal validity.
Effectiveness (phase 2) = extent to which favourable outcomes occur in real life setting/routine clinical practice. Determining the external validity.
Once efficacy has been established, effectiveness trials can be useful to unpack most important elements in psychological interventions.
Why is an RCT the gold standard for studies?
- Maximises internal validity (i.e., attributes outcome to treatment effect)
- Randomisation produces between groups equivalence of participants
- Rigorous controls and standardisation of treatment reduces variability in treatment delivery and outcome measurement
Why is assessing external validity important?
To ensure generalisability and application of results to routine clinical practice.
What are some reasons why clinical trials of addiction interventions are challenging?
- Interventions are often complex and include multiple interacting components
- Often have several relevant outcomes
- Risk that participants might withdraw after being randomised to less attractive treatment option - need sample to represent clinical population the intervention is aimed at
- Circumstances may prohibit randomisation (criminal justice, mental health)
What are other types of clinical trials besides RCT?
Individual randomised trial, cluster randomised trial, stepped wedge trial
