LECTURE 14 2011

LECTURE 14 2011 - Inclusion and Exclusion Criteria...

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Unformatted text preview: Inclusion and Exclusion Criteria (Defining the Study Population) General considerations Run-in periods (enrichment) Regression toward the mean General Considerations in Selecting Patients for Clinical Trials Broad or narrow criteria Uncertain eligibility Recruitment and patient logs Nature of clinical sites (patient to research or research to patients) Relationship of Study Sample to Study Population and Population at Large Population at Large Population without Condition Population with Condition With Condition but Ineligible Study Population Eligible but not Enrolled Study Sample Source: Friedman, Furberg and DeMets. Definition of Condition Entry Criteria Enrollment The Study Population is Defined by Inclusion and Exclusion Criteria Eligibility Criteria Should be defined in advance No exceptions should be made unless a priori stated Characterize population (e.g., labeling indication for a new drug/device) Impact of results Replication of study Considerations in Developing Eligibility Criteria 1. Enroll patients who have potential to benefit from intervention 2. Enroll patients for whom there is a high probability of detecting results of intervention 3. Do not enroll patients to whom intervention is potentially harmful 4. Do not enroll patients at high risk of conditions which preclude ascertainment of endpoints 5. Do not enroll patients who cannot comply with protocol Friedman, Furberg, DeMets: Fundamentals of Clinical Trials, Chapter 4 Selection of Patients for a Trial Drug clearly indicated based on current knowledge Exclude Drug effect unknown: But likely to be beneficial to certain patients Include* And outcome uncertain in certain patients ? Include But theoretical possibility of harm or little hope ?? Include* of benefit Special exclusions (competing risk, poor Exclude compliance, inability to ascertain endpoint) Drug contraindicated based on current knowledge Exclude Yusuf et al., Stat Med, 9:73-86, 1990. * Include such patients with explicit prior statement of a subgroup hypothesis Advantages and Disadvantages of Opposing Selection Strategies Highly restrictive selection criteria Advantages Provides more precise comparison of the test and control treatments Results of the trial less likely to be affected by population variability Disadvantages Increases the cost and time required for patient recruitment Limits the generalizability of the study findings Minimally restrictive selection criteria Advantages Makes patient recruitment easier Provides base for wider generalization of findings Disadvantages May obscure treatment effects because of variability in composition of study population Results of the trial may be confusing, especially if an observed effect appears to be associated with a subgroup of patients in the study and the subgroup is too small to yield a reliable treatment comparison Meinert C., Clinical Trials. Design, Conduct and Analysis. Usually Favor Minimal Restrictions for...
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This note was uploaded on 11/21/2011 for the course PUBH 7420 taught by Professor Ph7420 during the Spring '07 term at Minnesota.

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LECTURE 14 2011 - Inclusion and Exclusion Criteria...

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