At a time when clinical trials are becoming more and more
complex – due in no small part to increased regulatory
requirements – phase III trials are especially complicated, with
few drugs (approximately one-third) proceeding from phase II.
In such an environment, an organization seeking to conduct a
trial for a rare and complicated disease state, such as life altering
central nervous system (CNS) disorders, already faces
an inordinate challenge. Add further complications such as
managing a small patient population, running the trial within
urgent or emergency-type settings, like a hospital intensive
care unit (ICU), and the difficulty-level increases manifold.
Such a case would require partnership with a clinical research
organization (CRO) that could successfully undertake patient
eligibility screening, conduct the trial within a limited time
window due to the urgent nature of the patient’s condition,
and also deliver a thorough and quality data assessment to
meet critical clinical end points, on time and within budget.