Drug development challenges in liver disease clinical trials

Drug development process faces many challenges, including those encountered in clinical trials for liver diseases. Drug development is a lengthy and highly costly process. Only 10% of compounds entering first study in humans (phase 1) make it to the market after an average of 14 years with a cost of ~$3 billion. Interestingly, according to the Centers for Medicare and Medicaid services, prescription drugs constituted only 10% of each healthcare dollar spent in the USA in 2015. Examples of challenges encountered in liver clinical trials include lack of validated patient-reported outcome tools, blinding issues, and the use of placebo in addition to lack of health authority guidance for many diseases including orphan diseases. In ~80% of clinical trials, enrollment of the right patient is the leading cause of missed clinical trial deadlines, resulting in delayed availability of potentially life-saving therapies. Another specific challenge introduced by recent technology is the use of social media and risk of bias. Sharing personal experiences while in the study could easily introduce bias among patients, which would interfere with accurate interpretation of collected data. To minimize this risk, recent clinical studies incorporate as an inclusion criterion in the patient’s agreement not to share any of study experiences through social media with other patients during the study conduct. Consideration of these challenges will allow timely response to the high unmet medical needs...
Source: Egyptian Liver Journal - Category: Gastroenterology Tags: Review article Source Type: research