The Clinical Development of Drugs and devices is a challenging task, and more so than product development activity in most other industries. The technical challenges are huge because understanding of the biological systems involved is usually incomplete. The complexity is significant because patients vary significantly from
one another and are unpredictable in their responses. Additionally, every sponsor has to contend with the need for speed because of competition and the existence of budgetary pressures arising from the need to get a good return on investment in clinical development. The result is well known: success rates overall are low, New Drug Applications are too few, and the return on investment is abysmal.
Continue reading to understand the concept and benefits of adaptive trials and if they should be a consideration for your company.