Don't Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise
Whether the focus is endpoint adjudication, aggregate data monitoring or safety assessment, the clinical and device development industry clearly understands the value of establishing expert scientific committees to provide oversight on study data. These expert committee assessments provide validation on clinical data as additional support for regulatory submissions and commercial strategy. What is less well understood, however, is the importance of independent expertise. Without independent expertise, sponsors risk biased decision-making, conflicts of interest, potential clinical delays and squandered resources that could otherwise be avoided.