In this issue, we consider the topic of biomarker-based clinical trial design in oncology. A variety of thought-provoking clinical trials conducted internationally is considered. Reviews of past and ongoing biomarker-driven trials are provided for several of the most common malignancies, and specific high-profile trials such as NCI MATCH, LUNG-MAP, ALCHEMIST and FOCUS4 are reviewed in detail. The authors include clinicians and statisticians, who are integrally involved in these clinical trials and are expert in their respective fields. We hope that this series provides a useful overview of real clinical trials that are challenging the traditional clinical trial design paradigms. This is critical for advancing therapeutic development in this era of molecular medicine.
Daniel J. Sargent, PhD. Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Sumithra Mandrekar, PhD. Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Axel Grothey, MD. Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.