Point-of-care and utility in clinical trials: making quicker decisions to transform patient care and drug development

摘要

With the staggering costs of drug development, it is important to find strategies to reduce costs. TheUSDepartment of Health and Human Services estimates that the total cost across Phases I, II, III and IV of a clinical trial can currently range from 40 to US$100 million (depending on the therapeutic area) and is steadily increasing. It is also estimated that only one in ten drugs that start clinical trials are expected to enter the market [1]. For companies to remain competitive, and to continue to make life saving drugs available to a wider patient population, the costs and odds of success for clinical trials need to improve. One of the challenges in drug development is patient recruitment. Patient enrollment is reported as the most time-consuming aspect of the clinical trials. This is in part due to many clinical trials taking place at the same time for the same indications and looking to recruit from the same pool of patients. It has been reported that 20% of cancer clinical trials fail due to inadequate patient recruitment. According to Tufts Center for the Study of Drug Development, two-thirds of clinical sites do not meet enrollment requirements for individual trials [2]. One strategy used to improve these odds is to increase patient access and convenience to clinical trials and by enabling faster decision-making.