Blinding Learning outcomes:
➔ 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.
Outcome measures Learning outcomes: ➔ 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.
Assessing safety Learning outcomes:
➔ 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.
Adherence and complete follow up Learning outcomes: ➔ 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. Ethical issues in clinical trials Learning outcomes: ➔ 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.
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