Overview of Precision Oncology Trials: Challenges and Opportunities.

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Abstract

Introduction In recent years, the therapeutic management of selected patients with cancer has shifted towards the 'Precision Medicine" approach based on patient's mechanisms of tumorigenesis, and their baseline characteristics and comorbidities. Complete tumor and cell-free DNA profiling using next-generation sequencing, proteomic and RNA analysis, and immune mechanisms should to be taken into consideration and accurate bioinformatic analysis is essential to optimize patient's treatment. Areas covered The challenges and opportunities of conducting clinical trials in precision oncology are summarized. Expert commentary Precision medicine has significantly changed the diagnostic and therapeutic landscape of cancer. Successful implementation of precision medicine requires translational and bioinformatics infrastructure to support optimization of treatment selection. Targeted therapy, immunotherapy, T-cell therapy alone or in combination with cytotoxic or other effective therapeutic strategies and innovative clinical trials with adaptive design should be offered to all patients. Data sharing and "N of 1" models hold the promise to optimize the treatment of individual patients and expedite drug approval for rare alterations and tumor types. Artificial intelligence will facilitate accurate utilization of sequencing data to perform algorithm analysis. Collaboration of health care providers with pharmaceutical and biotechnical companies, scientific organizations and governmental regulatory agencies have a crucial role in curing cancer.