Designing a clinical trial Flashcards
What is a clinical trial?
A type of research that studies new tests and treatments and evaluates their effects on human health outcomes
What is the difference between aims and objectives?
Aims: set out what you want to achieve by the end of the study
Objectives: How you will achieve the aim through defined measurable outcomes
What is a protocol?
A set of instructions to carry out the experimental procedures to address the primary research question
The protocol provides a scientific basis for the study.
(can use SPIRIT guidelines to create a protocol)
Give examples of what is included in the protocol
Background Objectives Design Intervention Follow up visits and schedules Safety assessments Data analysis
What is the purpose of comparative trials? (superiority trials)
To demonstrate if treatment X is superior to standard treatment in terms of outcome measures.
The null hypotheses: 2 treatments have the same effect
What is the purpose of equivalence trials? (non-inferiority trials)
To demonstrate if X is no worse than standard treatment in terms of outcome measures
The null hypotheses: 2 treatments are different
The difference is set by predefined margins
When would non-inferiority trials be used?
Bioequivalence trials (to demonstrate the PK and PD equivalence)
when testing new treatment against a placebo is unethical (e.g. cancer treatments)
To test if new treatment has advantages over standard treatment.
Explain a parallel group design
Independent groups are allocated to different treatments
Explain a crossover study design
Participants receive the same treatments in different orders/sequences.
This could involve a washout period in between.