Client Project Examples Index

Adaptive Trial Design and Implementation for Phase 3 Oncology Treatment

Approach - Sample Size Re-estimation Design with “Promising Zone”
Client - Sunesis Pharmaceuticals
Chief Benefit - Rather than commit to a larger sample size up front, the decision is deferred until the clinical evidence justifies cost of added trial subjects.

Adaptive Design and Implementation in Phase 3 Cardio-Vascular Research

Approach - Adaptive Population Enrichment with two interim analyses
Client - The Medicines Company
Chief Benefit - “Two trials in one” reduces sponsor exposure to nuisance parameters – population and recruitment uncertainties – that threaten to slow research and jeopardize supporting funding

Cytel Clinical Research Services and Adaptive Design for Rare Disease Product

Approach - Adaptive non-inferiority trial with unblinded sample size re-estimation, combined with services: CDISC migration, ADaM development, ISS/ISE SAP & programming, CSR and ISS/ISE medical writing
Client - Raptor Pharmaceuticals
Chief Benefit - FDA and EMA approve product following adaptive confirmatory trial. Raptor estimates 20% savings through combination of Cytel adaptive design, data analytics and medical writing.

Approved Product Based on an Adaptive Two-Stage Study: Fulyzaq®

Approach - Adaptive two-stage (“seamless”) trial design enabling continuation from Phase 2b to Phase 3 without stopping
Client – Napo Pharmaceuticals
Chief Benefit – In 2013, Napo/Salix gains FDA approval to market their much-needed HIV/AIDS-related gastrointestinal distress treatment. Fulyzaq® is the first product resulting directly from a two-stage adaptive design.

Collaborative Research and Custom Software Development

Approach - Co-develop early phase adaptive trial design determination tools, test and support implementation
Client - Merck
Chief Benefit - a rigorously validated, open solution that’s helping Merck trial planners to determine optimal trial designs for both early and confirmatory studies

Outsourcing Biostatistics and Statistical Programming

Approach - Establish an outsourced “extension arm” with Cytel India dedicated team
Client - Merck Serono
Chief Benefit - Without compromising requisite quality, the Swiss-based developer increases output and reduces costs

Securely Managing Interim Analyses by Independent Committees

Approach - Deploying Cytel’s ACES system enabling secure reports and communication between study sponsor, DMC, ISC and sites.
Client - Multiple, including Pfizer and Sunesis Pharmaceuticals
Chief Benefit - ACES promotes regulatory trust with a secure, auditable environment, and also integrates decision-making engines to support DMC/DSMB interim analysis.