Current Edition

Increasing Therapeutic Complexity in CNS Clinical Trials: The Need for Therapeutically Aligned Staff

The recent rise in protocol complexity has been particularly evident in trials targeting CNS diseases, where, in the wake of some notable late-stage study failures in recent years, sponsors are increasingly emphasising the scientific integrity of experimental drug programmes in this space. To that end, when conducting CNS trials today, it is critical that sponsors and contract research organisations (CROs) implement better and more thorough processes and tools in areas such as patient eligibility screening and confirmation and the review of outcome data assessments, which, for many CNS indications, often contain subjective information. Andrew Silverman of INC Research discusses how, to meet these demands, CNS study teams are increasingly in need of clinical research associates (CRAs) that possess both therapeutic and technical expertise.