Special considerations for conducting clinical trials
Course overview and trial designs Learning outcomes: ➔ Define randomized controlled trial
➔ Identify three alternative study designs to randomized controlled trials ➔ Identify five reasons for not conducting randomized controlled clinical trials ➔ Identify four reasons for conducting randomized controlled clinical trials ➔ Describe four randomized trial designs.
Selection of participants Learning outcomes:
➔ Explain why it is important to develop detailed and specific eligibility criteria in a clinical trial ➔ Describe advantages and disadvantages of defining a broader versus narrower population in a trial ➔ Describe at least three appropriate reasons for excluding participants from a clinical trial.
Recruitment Learning outcomes:
➔ Describe two goals of recruitment ➔ Identify two study design issues ➔ Identify three strategies to recruit appropriately ➔ Identify four recruitment methods.
Choosing the interventions and controls Learning outcomes: ➔ Describe aspects of the experimental intervention that should be defined in the planning stages of a trial ➔ Identify at least three important functions of a control or comparator intervention in a trial ➔ Assess the strengths and weaknesses of common controls for pharmacologic, surgical, or behavioral interventions.
Randomization Learning outcomes: ➔ Describe the importance of randomization in clinical trials ➔ Describe simple randomization ➔ Describe randomized permuted blocks.
Return to contents page
10
Powered by FlippingBook