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European Biopharmaceutical Review

Innovation in Oncology Clinical Trials

Until the 1990s, the understanding of tumour biology was largely descriptive in nature, and selectivity of oncology drugs was based largely on tumour cell characteristics, such as increased cell replication rate, capability to migrate and invade tissue, being able to evade recognition and destruction by the immune system, and capacity to evade normal mechanisms of senescence and apoptosis.

Traditional cancer therapy strategies centred around treating the tumour based on histological considerations and treating the entire patient population as an average. This ‘averaging’ of patients failed to effectively distinguish between patient subpopulations. Now, advances in genomics have ushered in a new era of precision medicine using methods to identify specific patient subpopulations based upon specific tumour lesions followed by utilisation of select lesion-specific targeted drug therapy.

This new era marks a shift from histology-based to lesion-based trial designs. This article explores how biomarker-based trial designs are reframing the clinical trial landscape and the latest FDA guidance on enrichment strategies for biomarker-based trial designs.

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Dr Brian Huber is a leader in the biopharmaceutical drug development, CRO service, and investment sectors, with over 35 years’ experience. His current position is the Vice President of Therapeutic Areas, Drug Development, and Consulting at ICON.

Dr Huber’s experiences include VP & Managing Director at Quintiles/IQVIA, Global VP in Drug Discovery at GSK, CEO of Shionogi/GW Pharmaceutical Inc., Director of Oncology at Burroughs Wellcome, and Senior Staff Fellow at the National Cancer Institute, NIH, in Bethesda, US. Dr Huber has 11 issued patents, 65 publications in peer-reviewed journals, and a number of books and book chapters.
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Brian Huber
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