Late Stage Clinical Trial Services
Late Stage Trial Solution
For a sponsor faced with running two separate traditional trials, Cytel designed a single confirmatory trial. The FDA-accepted design adapts based on early trial data “looks”: interim analysis IA-50% and IA-70%
- IA-50% allows for early stopping for efficacy or futility
- IA-70% options include enriching the patient population into the most responsive sub-groups
Success Strategies for Confirmatory Studies
The need for efficient trial design doesn't end after early development. Entering the confirmatory phase, evidence exists that your compound is efficacious. The goal is to achieve all development plan objectives in the most efficient way.
However, there is a real risk of failure to provide adequate evidence of efficacy as we are often moving from studies conducted at a small number of sites to multinational trials, or from studies with biomarker and points to studies with clinical endpoints. Cytel specializes in new and innovative confirmatory phase trial designs that help mitigate against these risks.
Cytel has extensive experience in designing confirmatory phase trials, and understands regulatory agency requirements, particularly for new and innovative approaches. Cytel brings this experience to the table in designing confirmatory trials with the greatest chance of clinical success.
Confirmatory Study Designs
- Seamless phase 2/3 trials
- Enrich study populations
- Adjust sample size
- Drop treatment arms
- Simulate trial results
- Provide regulatory, IRB (Independent Review Board) support
- Late phase design experience includes oncology, cardiovascular, immunodeficiency/HIV-related, CNS, gastrointestinal, respiratory, pain, psychiatric and rare disease treatments