Re-Innovation in Clinical Trial Designs Based on Precision Therapy

    September 2025 in “ Cancer Innovation ”
    Shenglan Li, Jiachen Wang, Zhuang Kang, Xun Kang, Feng Chen, Wenbin Li
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    TLDR Clinical trials should use innovative designs and biomarkers to improve precision therapy and patient outcomes.
    The document explores the transformation of clinical trial designs in precision medicine, focusing on patient-centric approaches and innovative trial designs like basket, umbrella, and platform trials. These designs address limitations of traditional trials by allowing for concurrent evaluation of multiple treatments, improving efficiency, and capturing patient diversity. Biomarker-based precision medicine, demonstrated by trials such as BFAST and FUTURE, enhances treatment precision through liquid biopsies and molecular profiling, leading to improved progression-free survival and response rates. The European AcSé-ESMART trial, with 255 patients, exemplifies the efficiency of multi-arm and multi-stage designs, while the ROSSINI-2 trial highlights the benefits of interim analysis. The document also discusses the potential of compounds like chlorogenic acid and honokiol in promoting hair growth, and innovative administration routes like the Ommaya reservoir for oncolytic virus delivery, which enhance patient compliance and monitoring.
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