Innovations in clinical trials

摘要

Significant advances have been made in the design and execution of clinical trials in order to maximise their chances for success and reduce their costs. Advances such as adaptive designs focused on the needs and opportunities to innovate drug development, bringing increased efficiency and improved decision making, and ultimately increasing the likelihood of bringing beneficial therapies to market. Also involving the end-user of drug development, the patient, into the design selection process of clinical trials turns out to be an essential success factor as it helps clinical trialists to strengthen the trial's relevance and acceptance for the patient. During the execution phase, emphasis on risk management such as risk-based monitoring helps the study teams to focus their attention and activities on the areas of greatest need: patient safety and data quality. This session was intended to provide expertise on current challenges, innovative improvement options and an update on expected methodological changes in clinical trials.