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. Precision medicine tailors treatment to a patient's unique traits, making it more exact in terms of how treatment affects specific individuals. Clinical trials are studies in which investigational drugs, technologies, or biologics, such as chemotherapy, blood products, or gene treatments, are tested for safety and efficacy in human volunteers. Building a therapy hypothesis, determining which patients react and why, and developing effective procedures for identifying those patients are all steps in precision medicine. The method entails considering drug delivery, biomarker response, and the diagnostic tool for locating the appropriate individuals. Clinical trials and medical therapy can become more successful, efficacious, and efficient as medicines are identified based on analytics. Clinical trials for precision medicine have several ethical and regulatory difficulties in common with clinical trials in general.

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