How is Individual Expanded Access Different from Clinical Trials?
Clinical trials are designed to systematically evaluate the safety and efficacy of new treatments in a controlled environment. Participants in clinical trials are randomly assigned to receive either the investigational treatment or a control (standard treatment or placebo). In contrast, individual expanded access is intended for patients who cannot participate in clinical trials and are in need of immediate intervention. The primary goal of expanded access is to provide treatment rather than to collect data.
