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Abstract:
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One key component of conducting a successful clinical trial is a good selection of the primary endpoint. In some diseases, where patients have many different symptoms, it is not easy to correctly identify a single primary endpoint, which can efficiently measure all patients' disease manifestation. For example, depending on patients who have either irritable bowel syndrome (IBS)- diarrhea or constipation, patients may have abdominal pains in addition to the diarrhea or constipation. Therefore, in order to accurately measure IBS patients' improvement, a composite responder type of endpoint that can simultaneously capture responders in both components needs to be considered.
In this presentation, we will consider some issues with making regulatory decisions based on examples with multiple primary endpoints and composite endpoints in clinical trials when the evaluation of drug's efficacy needs to rely on the totality of the evidence.
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