Clinical Trial Design

Physicians and statisticians in the Clinical Investigation Core have years of expertise in designing and implementing HIV-related clinical trials. They are familiar with numerous statistical tools, as well as the limitations and biases inherent to various analytical approaches. We offer consultation in the following areas:

• Study design
• Informed consents
• IRB approvals
• Data entry forms
• Database design
• Randomization schemas
• Sample size/power calculations
• Statistical hypothesis generation
• Analytic plans
• Final analyses