Special considerations for conducting clinical trials
Course overview and trial designs
Selection of participants
- 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.
- 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.
Choosing the interventions and controls
- Describe two goals of recruitment
- Identify two study design issues
- Identify three strategies to recruit appropriately
- Identify four recruitment methods.
- 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.
- Describe the importance of randomization in clinical trials
- Describe simple randomization
- Describe randomized permuted blocks.
- Define blinding and identify ways to blind many interventions
- Identify three ways that blinding minimizes potential bias for
- Identify four types of interventions that cannot be blinded
- Describe strategies to implement if the study cannot be blinded.
- Describe at least two reasons for using one primary outcome
- Identify two types of data that support that a measure is a ‘valid’ surrogate marker for treatment
- Identify the main criterion for determining whether a marker is a valid ‘surrogate’ endpoint
- Describe two pros and cons for using composite outcomes.
Adherence and complete follow up
- Define a serious adverse event
- Describe one pro and con of elicited vs volunteered adverse events
- Describe reasons for using a formal adjudication process for clinical outcomes
- Identify one disadvantage of adjudication.
Ethical issues in clinical trials
- Describe two important reasons for adherence to the protocol
- Describe five ways that adherence can be measured
- Identify two ways to maximize adherence to the protocol
- Identify four ways to maximize follow up
- Describe three analytic techniques to use for poor compliance during a trial
- Describe two effects of non-adherence.
- Identify ethical issues in clinical trials
- Describe factors for acceptability of random assignment to a treatment
- Define interim monitoring
- Describe two basic goals of interim monitoring in a blinded trial
- List four reasons to stop a trial early
- List four components of a data monitoring plan
- Describe conflict of interest issues in clinical trials
- Describe three ways of performing scientific misconduct
- Define contributions needed to qualify as an author on manuscript.
How to write up industry-sponsored trials
- Define regulations that apply to clinical trials
- Describe good clinical practice.
- The evidence on misreporting of industry trials
- Potential pitfalls of using composite end points in trials
- Reporting of authorship for industry studies
- How to report industry trials transparently
- Good publication practice (GPP3) for industry studies.