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The Roles of Short Term Endpoints in Clinical Trial Planning and Design

By Christopher Jennison

Abstract

Examples of short term endpoints Short term responses can often provide an indication of how a treatment will ultimately affect the primary, long term endpoint. Short term endpoint Long term endpoint Altzheimer’s disease Change in mental acuity Change in mental acuity score after 2 months score after 6 months Osteoporosis Bone mineral density Fracture Cancer Progression free survival Overall survival HIV infection CP4 count or viral load Progression to AIDS A short term endpoint can guide the direction of a trial or of a sequence of trials. More radically, a short term endpoint may be used as a substitute or “surrogate ” for the real endpoint. 2 Benefits of using short term endpoints A short term endpoint may be more convenient to use if it is: More rapidly observed, Less expensive to measure. A short term endpoint may provide good insight into a treatment’s effect if it: Is more immediately affected by the treatment, Has a high incidence rate, while the long term endpoint concerns a rare event. But, remember that the goal is to demonstrate a treatment effect on the long term endpoint

Year: 2010
OAI identifier: oai:CiteSeerX.psu:10.1.1.353.3698
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