THOUGHT LEADERSHIP

Proper site management by the Sponsor and/or CRO is an essential element of clinical trial execution and in ensuring trial success. An appropriate level of site management and oversight empowers sites to effectively recruit, treat, and retain subjects while ensuring regulatory compliance, protocol adherence, the protection of subjects’ rights, subject safety, and overall management of screened and enrolled subjects.

Today’s clinical development is more patient-centric – focusing not only on treating the patient’s disease or dysfunction but also on the patient’s experience of, and desired outcomes for, treatment.

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS). It is hypothesized that CNS auto-reactive T cells are stimulated in the peripheral circulation to become active and proliferate, with subsequent migration into the CNS compartment.

Patient-reported outcome (PRO) instruments, such as patient-completed (or interviewer-administered) diaries, questionnaires, and visual analog scales (VAS), have been a part of clinical research for many years.