Case Study

Delivering on Diversity in a Phase 2b Diabetic Peripheral Neuropathy Study

Study Objectives

Enrollment of 416 participants, across 100 sites, study wide
Alliance Clinical Network Goal: Enroll 10 participants

Challenges
During the execution of the study, Alliance Clinical Network encountered some challenges, including:

Study Population Diversity: Identifying participants who not only meet the strict inclusion/ exclusion criteria but also help increase diversity across the study population.
Screen Failure Rates: Screen fail rates for CNS trials routinely surpass those in other therapeutic areas due to the complicated nature of neurological and psychiatric disorders.
Participant Compliance: For participants to continue the study, they are required to complete >70% of daily pain diary entries and >80% of dosing compliance during their double-blind treatment period.

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