Highlights from PHASTAR's Life Science Reception

On Thursday, June 13th, PHASTAR hosted its first Life Science Reception in Cambridge, MA, at the Royal Sonesta hotel. Representatives from a number of leading pharmaceutical and biotech companies were in attendance.

After opening remarks from Founder and CEO Kevin Kane and Managing Director Andrew MacGarvey, Paul Stark, the Director of PHASTAR’s Boston/Cambridge office launched the evening’s technical program with a thoughtful discussion of the benefits and risks of planning interim looks at clinical trial data; that is, assessing trial outcomes before the trial is fully completed.  Whether framed in a Bayesian or a classical frequentist approach, this exciting branch of adaptive trial design can dramatically reduce the duration and number of subjects required to conduct a trial but requires expert design to optimize its advantages, avoid critical pitfalls, and ensure regulatory acceptance.

With this foundation set by the first presentation, in the event’s second technical talk, Pat Mitchell, Statistical Science Director in Early Clinical Development for AstraZeneca (AZ) provided insight into continuous monitoring of clinical trials, where results are evaluated after every patient is enrolled.  Whether monitoring for efficacy, futility, or safety these modern methods signal a coming revolution in trial conduct.  In cooperation with AZ, PHASTAR have constructed an adaptable template for conducting optimized early phase oncology studies, incorporating the economies and insights provided by elements like interim analyses, continuous monitoring, and other adaptive approaches.

Connecting the powerful analytic approaches introduced by the first two speakers to the source data that will ultimately be analyzed, the third speaker, Gregory Vassar, a Senior Manager for Partners at Medidata demonstrated Medidata’s powerful approaches to integrative data management and intelligent trial solutions that capitalize on their wealth of experience and historical data.  These tools enable Medidata to make predictions that can enhance clinical trial operations, for instance in risk-based quality and safety monitoring or by providing historical placebo or other comparator groups. PHASTAR is excited to be partnering with Medidata going forward as we continue to enhance and expand our integrated suite of services.  The rapid and accurate access to data provided by Medidata is essential in the conduct of trials that use adaptive approaches like those presented during this session.