Veristat LLC. a leading Boston-based clinical research organization today announced its advisory role on the implementation of an adaptive enrichment trial design for Verastem Inc. . The enhanced design aims to optimize the current trial of defactinib a novel small molecule inhibitor of focal adhesion kinase (FAK) in patients with malignant pleural mesothelioma.
“We have identified a biomarker in mesothelioma that may predict increased sensitivity to defactinib” said Dr. Joanna Horobin Chief Medical Officer at Verastem. “We felt strongly that the application of an enrichment design would help us to accelerate the program to a potential regulatory decision. We are excited to have Veristat’s experience in enrichment trial design and execution supporting this trial.”
Veristat’s input on the overall trial design as well as the adaptive enrichment design architecture and planned analyses will help facilitate decisions required at key development intersections of the program.
“The Verastem clinical development team has taken a dynamic approach to the design of this study” commented Dr. John Balser President at Veristat. “Our team at Veristat will be assisting them with the statistical and operational challenges inherent in the adaptive enrichment design architecture. Our goal is to produce a trial that will quickly and cost effectively yield the highest likelihood of success for their target patient population.”
Bringing 20 years of experience to its clients Veristat is a clinical research organization (CRO) that supports pharmaceutical biotechnology and medical device companies through every phase of the clinical trial process as well as the preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Visit www.veristat.com.