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European Pharmaceutical Contractor
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| Tomasz Burzykowski at MSOURCE Medical Development looks at surrogate endpoints in drug development as a method for accumulating study data and streamlining trial design
The development of a new medicine is a long and complex process. The candidate drug must pass through a series of phases of clinical trials, in which the efficacy and safety of the drug have to be rigorously established. The longer and the more complex the trials, the longer the time needed for bringing the drug to the market.
CLINICAL ENDPOINTS
One of the most important factors influencing the duration and complexity of a clinical trial is the choice of the endpoint, which will be used to assess the efficacy of the treatment. To this aim, clinical endpoints are used. A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions or survives. Two main criteria to select the endpoint to use in a clinical trial are its sensitivity to detecting treatment effects, and its clinical relevance to goals of the study. It often happens, however, that the most sensitive and relevant clinical endpoint – the ‘true’ endpoint – might be difficult to use in a trial. This can happen if the measurement of the true endpoint: |
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10th-Anniversary Event RFID Journal LIVE! 2012
3-5 April 2012, Walt Disney World Swan and Dolphin Resort, Orlando, Florida
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