Clinical Trials in Oncology and Defining Benefit
The article emphasizes the importance of defining efficacy and futility in oncology clinical trials from the patient's perspective, highlighting that what may be effective for one patient could be futile for another. It advocates for precision oncology, which integrates improved efficacy markers with well-designed trials while understanding individual patient values. The promise of precision oncology lies in personalized treatment approaches where benefit is tailored to the specific characteristics and preferences of each patient.
In the editorial “The Evolution of Clinical Trials in Oncology: Defining Who Benefits from New Drugs Using Innovative Study Designs”, Goldberg nicely discuss many changing aspects of clinical trial design in oncology. However, I believe their title is misleading. No study will define “who benefits” but only who might benefit. For example, human epidermal growth receptor 2 over expression or gene amplification in breast cancers epitomizes a remarkable example of a predictive marker validated to show benefit. Still, adjuvant trastuzumab benefits less than half the patients who receive it compared with chemotherapy alone...
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