Precision medicine in guiding clinical trials

Precision medicine is a method of improving patient outcomes by combining clinical and molecular patient data to better understand the disease's biological foundation. Based on specific patient characteristics and unique molecular features of a disease, this approach informs the selection of the most appropriate targeted therapy. Clinical trials are studies in which investigational drugs, devices, or biologics, such as chemotherapy, blood products, or gene treatments, are tested for safety and efficacy in human volunteers. Parallel to the increasing complexity of clinical trials, new frameworks have been built for stronger and faster collaboration between all stakeholders in drug development, including clinicians, pharmaceutical corporations, and regulatory bodies.

• FDA approval
• Adaptive studies
• Umbrella protocols
• Basket trials