CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cytel Inc., a leading provider of clinical research services and software announces that its work with customer TRACON Pharmaceuticals was recognized as Most Innovative Trial Design 2017 at the second annual Clinical and Research Excellence (CARE) Awards.
Managed by Informa’s Pharma Intelligence, home to trusted brands such as the Pink Sheet and Scrip Intelligence, the CARE Awards celebrate excellence across the global clinical research enterprise. A panel of distinguished judges, comprising independent experts from across the industry, presented the accolade to Cytel and TRACON Pharmaceuticals at an award ceremony in Boston in April.
TRACON Pharmaceuticals’ randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma (TAPPAS), was commended by the judging panel for its effective and novel design. Cytel’s biostatistics experts worked with TRACON Pharmaceuticals to create the groundbreaking adaptive trial, which has received a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) and analyzes TRC105 safety and efficacy data in real-time to determine the final study sample size and treatment population.
“This award is an important acknowledgement of the efforts of TRACON and our partner, Cytel, to design the TAPPAS trial with greater flexibility and efficiency to identify potential signs of clinical benefit in angiosarcoma, a rare and aggressive tumor with limited treatment options,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON.
TRACON is enrolling patients in the Phase 3 TAPPAS trial at sites in the U.S. and Europe. Further details of the trial are available on www.clinicaltrials.gov under NCT02979899.
Cyrus Mehta, Ph.D., President of Cytel, said “This trial utilizes an innovative adaptive enrichment design that adjusts the sample size and the patient population based on an interim analysis of the accruing data. It is ideal for rare diseases like angiosarcoma where prior data are scarce and patient enrollment is difficult. The design was approved by both the FDA and EMA for adoption in a confirmatory Phase 3 setting.”
Adaptive designs have the potential to increase efficiency in clinical development, and deliver benefits to both clinical trial participants and future patients of vital new medicines.
Yannis Jemiai, Senior Vice President Strategic Consulting at Cytel, added “Applying our biostatistics knowledge, we work with our customers to design trials that help to maximize a new therapy’s chances of demonstrating a benefit while mitigating the risks. We are thrilled that the CARE Awards’ judging panel has affirmed our leadership in the increasingly important adaptive trial space, and recognized the significance of the TAPPAS trial design in this area of high unmet medical need.”
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At Cytel, we’re shaping the future of drug development. As the world's largest Biometrics CRO, we improve our customers’ chances of clinical development success through expert trial design and planning, efficient operational implementation and accurate data analysis. Cytel's software for design, analysis, and execution of clinical trials is used by all leading pharmaceutical, biotech, and medical devices companies.