LECTURE 20 2011

LECTURE 20 2011 - Trial Objectives Superiority,...

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Unformatted text preview: Trial Objectives Superiority, Non-inferiority, and Equivalence Questions of Interest Is the new treatment better than the control treatment that I am using now? (superiority trial) If it is not better , is the new treatment as good (not unacceptably non-inferior) as the control treatment that I am using now? (non-inferiority trial) Can I use the new treatment and the control treatment interchangeably? (equivalence trial) Non-inferiority and equivalence trials are usually considered when there is an active control. Definitions (ICH Guidelines E9) Superiority trial a trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). Equivalence trial a trial with primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant (active control). Non-inferiority trial a trial with the primary objective of showing that the response to the investigational product is not clinically inferior (or not unacceptably inferior) to a comparative agent (active or placebo control but usually active) very common in the regulatory setting either for a new treatment or for a new label indication. Reasons for Active Controls An active treatment (comparator) with established efficacy exists. If superiority can be established, the standard of care is improved. If the outcome is morbidity/mortality a short- term trial with use of a placebo is not practical (recall papers by Temple and Ellenberg). The Number and Type of Active Comparator Studies Vary by Sponsor (Commercial versus Non-Commercial) Among published reports of trials between June 2008 and September 2009 in major medical journals, 97/212 (46%) used an active comparator. 36/108 (33%) with commercial sponsors and 61/104 (59%) with non-commercial sponsors. 18/36 (50%) of active controlled commercial trials were non-inferiority versus 5/61 (8%) of non-commercial trials. JAMA 2010; 303:951-958 Examples Non-Inferiority - 1 Is a new left ventricular assist device that provides a bridge to heart transplant as effective in keeping patients alive until a heart becomes available as one of the FDA-approved devices? Is a new vaccine for pertussis (whooping cough) that has an improved safety profile as effective in preventing whooping cough as the currently licensed vaccine? Is a single dose of a drug (low dose) equivalent to a twice a day dose (high dose)? Examples Non-Inferiority - 2 Is a short course of treatment for latent TB infection (3 months of INH plus rifapentine) as effective as 9 months of INH in preventing active TB? Example - HIV Trial: Abacavir-Lamivudine-Zidovdine vs Indinavir-Lamivudine-Zidovudine JAMA 2001;285:1155-1163....
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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 20 2011 - Trial Objectives Superiority,...

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