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

By Christopher Jennison


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
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