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Personalized Medicine and Clinical Trials: A Q&A With Apostolia M. Tsimberidou, MD, PhD

Tsimberidou: We had several breakthroughs and milestones over the past few years. For example, in 2011, the FDA approved vemurafenib and several other targeted therapies for patients with metastatic melanoma. In the past 3 years, the FDA approval of several immunotherapeutic agents and strategies has improved patient outcomes. 

As for future milestones, the drug development process should become concise and efficient. The current system of new drug development should be carefully reviewed, and the dysfunctional components should be eliminated. The focus of clinical research should become patient centered, and it should encourage innovative research that is promising to improve patient care.

The main focus should be on prevention of diseases, including cancer; implementing lifestyle modification, starting from raising awareness about obesity, hypertension, diabetes, and hyperlipidemia; encouraging physical activity and stress management; and emphasizing screening tests following the standard guidelines.

Moving forward, we should strive to have more complete assessments of tumor biology and more careful selection of treatments. At this time, insurance companies determine patient care, based on the drugs that are FDA approved. In the next few years, if we focus our energy and efforts on the discovery of new and effective targeted agents, optimize the treatment selection process based on patients’ characteristics, expedite the drug-approval process, and eliminate inefficient processes and unnecessary costs of drug development (associated with CROs and administrative costs), we will accelerate the implementation of precision medicine. We need to continue to explore novel therapeutic strategies, illuminating the complex mechanisms of tumor biology and combining these novel approaches with the existing drugs to cure cancer.

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