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Latest Issues in Regulatory Statistics: A review of the latest CHMP Biostatistical Guidelines currently under review
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Veröffentlicht: | 8. September 2005 |
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This talk will focus on the key statistical issues raised in new CHMP Biostatistical Guidelines. CHMP biostatistical guidelines are written to help medical assessors in regulatory agencies across Europe evaluate the efficacy of products submitted by pharmaceutical companies to them to obtain a marketing authorisation for a medicinal product. In turn these guidelines are used by the pharmaceutical industry to aid them in designing an appropriate clinical development program for a medicinal product. In particular this talk will focus on the recently adopted CHMP Points to Consider document on the Choice of Non-Inferiority Margin and CHMP Guideline on Data Monitoring Committees. The talk will also address some of the statistical issues raised in the CHMP guideline on the use of flexible designs in confirmatory clinical trials that is currently being written.