Clinical Protocol Design

Without a protocol that prescribes a well-designed study, a clinical trial can be doomed to fail before it even begins. Oncology trials are especially difficult to design and execute, and can present a wide range of problems not seen with any other disease indication. Methodological advances in statistics, like use of adaptive sampling techniques, make study design selection even more difficult.

Prologue has the experience necessary to deal with the unique challenges of an oncology study; our clinical protocol design services span across all departments, assimilating information from a wide range of expertise. The unique combination of medical, statistical, regulatory, and operational input is unmatched. What this means to you is that with Prologue's assistance, the design of your study will efficiently meet its stated objectives and allow you to plan the next set of trials with a high level of confidence. The bottom line is a reduced clinical development time with possibly fewer patients and lower costs than expected.

Study Design Activities Include:

• Defining the study hypothesis including definition of key endpoints
• Writing the Protocol
• Designing Case Report Form(s)
• Organizing investigator meetings
• Determining a sample size and study duration
• Devising a statistical sampling plan for minimizing exposure of patients to inferior/toxic treatments
• Writing interim analysis plans, including use of stopping rules for efficacy and futility
• Performing Analysis Planning and related data summary activities
• Providing regulatory guidance and insight

- Particular expertise in adaptive clinical trials and protocol design -