10class.wk9 - PubH 5462 Clinical Trials: Readings for Week...

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PubH 5462 Clinical Trials: Readings for Week 9 1. Friedman, Furberg, and DeMets. Fundamentals of Clinical Trials , Chapter 16. Supplemental Reading/References 1. Pocock, SJ. Clinical Trials: A Practical Approach. John Wiley and Sons, Ltd., Chapters 12 and 14. 2. Sackett DL, Gent M. Controversy in counting and attributing events in clinical trials. NEJM , Vol. 301, 1410-1412, 1979. 3. Gail MH. Eligibility Exclusions, Losses to Follow-up, Removal of Randomized Patients, and Uncounted Events in Cancer Clinical Trials. Cancer Treatment Reports 69:1107-1113, 1985. 4. Lachin J. Statistical considerations in the intent-to-treat principle. Cont Clin Trials , Vol 21, 167-189, 2000. 5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Statistical Guidelines fo Clinical Trials E9, February 1998. 1
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Intention to Treat Analysis (def.) an analysis in which patients are included in the group to which they were randomized irrespective of compliance, administrative errors, e.g., error in eligibility, or other protocol deviations. This analysis has the advantage of comparing groups comparable at entry because of randomization, but has the disadvantage that treatment differences may be diluted because of the enrollment of ineligible patients or non- adherence to the treatments. Thus to preserve power such dilution should be planned for by inflating sample size. An intention to treat analysis can be viewed as a comparison of treatment policies (i.e., a comparison of plans to give one treatment or another). International Conference on Harmonization (ICH) guidelines use the term "full analysis" set to refer to the set of all patients randomized. "Treatment Received" Analysis (def.) an analysis in which patients are included in the group corresponding to the treatment they actually received; patient compliance and "switchovers" are considered in the analysis. Sometimes this is referred to as a "per protocol" analysis. ICH guidelines use the term "per protocol" set for defining the a group of patients who were "adherent" to the protocol. Typically, in a "per protocol" analysis, patients who do not meet all of the eligibility criteria or do not adhere to the protocol are excluded, and events that occur after treatment discontinuation are excluded. While this analysis has the obvious advantage of an "undiluted" treatment difference, it is potentially biased, and the magnitude of the bias is not easily or reliably quantifiable. . Peto (Br. J Cancer , 1976) makes the following argument for intention to treat analyses: If protocol deviations are minor or infrequent, it probably is irrelevant how they are handled, therefore include all patients randomized in the analysis. If protocol deviations are common, the trial is suspect.
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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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10class.wk9 - PubH 5462 Clinical Trials: Readings for Week...

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