CancerPartners UK shares Top Tips on Enriching Patient Populations in Phase III

Top Quote Karol Sikora, Medical Director at CancerPartners UK, joined Pharma IQ to discuss new trial design approaches and biomarker application methods coming on stream to drive oncology clinical development. End Quote
  • (1888PressRelease) January 26, 2011 - When speaking to Helen Winsor, Karol pinpointed that the main issue surrounding biomarkers and surrogate endpoints in cancer was conflict between commercial development and rational scientific development. According to him, there are two new methods being explored to enrich patient populations in Phase III. One is to selects patients that are likely to respond and putting those into Phase III rather than the whole population and the second one is to have some biomarker which detects the surrogate endpoint very quickly, within 24 hours of drug administration.

    "The difficulty with that is that you are going to have take patients out but if it's only a small percentage then that's fine and you will enrich the Phase III arm for those that are more likely to benefit'' says Karol.

    During his interview, he also discussed benefits of holistic approaches to biological subclassification of disease, how we can evaluate mechanism driven biomarkers and how we can potentially use biomarkers for life-cycle extension of current compounds.

    You can listen to the full interview on Pharma IQ web:

    The interview has been conducted in relation to Pharma IQ's 2nd Annual Optimising Clinical Development in Oncology event, taking place 15 - 16 March, 2011 in London. The event is co-located with clinical Optimising Clinical Development in CNS as a part of Clinical Trials Summit.

    For more information, please visit, email enquire ( @ ) iqpc dot or call 44 (0) 2073679300

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