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:

1. Study Population Diversity: Identifying participants who not only meet the strict inclusion/ exclusion criteria but also help increase diversity across the study population.
2. 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.
3. 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.