ABSTRACT
The idea of precision medicine came into existence that all patients who received the same therapy do not respond in the same manner and there exists an inter-individual variation. Researchers then found that precision medicine plays a vital role which may lead to treatment failure or toxicity. Precision medicine will provide the right medicine at the right time to the right patients with specific characteristics for a better clinical outcome. It utilizes the information related to a person’s genes, proteins and environment to cure disease. This breaks the model of “one fits for all” and it helps us to sequence DNA which is unique for everyone and to decide therapy based on the genetic information. The difference between the terms “precision medicine” and “personalized medicine” is to be understood since the former will classify people into subpopulations that have difference in their susceptibility to disease and the latter refers to a single drug for a single individual. It has its applications to detect any genetic alterations starting before birth and till old age. Due to this reason, precision medicine has taken over the personalized medicine and the word “precision” means accurate and precise.
ABSTRACT
@#The umbrella trial has received increasing attention in the design of clinical trials for oncology drugs in recent years. This trial design categorizes a single disease into multiple sub-types based on predictive biomarkers or other predictive factors, and simultaneously evaluates the efficacy of multiple targeted therapies. When compared with the traditional drug development model of phase Ⅰ, phaseⅡ, and phase Ⅲ randomized controlled trials, umbrella trials are a more scientifically rigorous trial design that can speed up drug evaluation to address the conflict between numerous untested drugs and diseases with a lack of effective treatment options. This article will focus on the concept, main characteristics, eligibility criteria, design and statistical considerations, ethical considerations, and future directions of umbrella trials, with the aim of providing methodological guidance for the design of clinical trials for oncology drugs.