Berry Consultants Announces Formation of Clinical Trial Strategy Team

Berry Consultants LLC has formed a new Clinical Trial Strategy team to provide strategic, scientific, and process design expertise to groups establishing large-scale clinical trial platforms for drug, device or diagnostic evaluation. The team provides guidance and support for the implementation and improvement of adaptive and platform clinical trials, as well as expert training on their execution.
 
 “It has long been our aspiration to build a team at Berry Consultants to help clients implement and operationalize platform and adaptive trials. It complements the efforts of our Statistical team to create innovative adaptive platform trials and further their use in clinical research,” said Dr. Scott Berry, President of Berry Consultants.

Dr. Don Berry, founder of Berry Consultants, added, “The Strategy team is led by very talented and innovative researchers who can make a real difference in advancing clinical trials.”
 
Platform trials efficiently evaluate multiple treatments simultaneously and employ unique statistical analyses to define best therapies. They are a natural extension of Bayesian adaptive designs and are the best hope to fulfill the promise of precision medicine, defining individualized treatment for patients based on molecular drivers or phenotypes (Berry et al. JAMA 2015). There are a number of high profile platform trials currently active, and interest by industry, academic and advocacy groups in building new ones continues to grow.
 
“We aim to design and implement platform and adaptive clinical trials across many clinical areas,” said Dr. Meredith Buxton, director of Clinical Trial Strategy, “by providing practical advice and proven experience to enable more groups to build these innovative efforts.”
 
Platform and adaptive trials have many unique characteristics that define their value. Notably they allow the use of smaller patient populations and a shared infrastructure to be both patient friendly and cost effective. Additionally, statistical benefits like response adaptive randomization better identify the benefit or risk of a therapeutic strategy, assay, or device for a specific patient population or subtype.
 
“The data that emerges from adaptive and platform trials allows more informed clinical decision making,” said Dr. Melissa Paoloni, director of clinical science, “so we believe they offer a unique benefit to patients and can be game changers for development across all sectors.”
 
Clinical Trial Strategy offerings range from trial development, to first patient initiation, operations oversight, partnership building, data analysis, and project consulting.
 
Berry Consultants is a clinical trial consulting company specializing in clinical trial design, analysis, execution, and software solutions for the pharmaceutical and medical device industry. The company is based in Austin, Texas.