September 18, 2022
There’s more than one way to architect a decentralized clinical trial (DCT). While this flexible model has many benefits, it can be overwhelming to bring together all the right elements to operationalize a trial that’s predominantly digital. Every trial is unique, so it is not realistic to templatize (impose a standard implementation template on) a DCT. But four common, fundamental components combine to facilitate a seamless, patient-centric DCT.
“It’s like a trial in a box, but each box is a little bit different,” said Steve Rosenberg, CEO of a cloud-based platform company that powers decentralized clinical trials. Even with a DCT’s inherent optionality, foundational components can ease implementation and improve execution.
Curavit chosen for expertise in decentralized trial design and execution.
Beechtree Labs has chosen Curavit Clinical Research for a fully decentralized clinical trial to investigate a promising Covid-19 therapy. The FDA-authorized phase 2 clinical study will evaluate the effect of Beech Tree’s BTL-TML therapy on mean duration and severity of disease in 40 outpatients aged 60 years or older with underlying conditions. The study also assesses the safety of BTL-TML over 10 days of treatment and an additional four days of follow-up.
The trial is unique in that it is a fully decentralized clinical trial, made possible by applying virtual trial design protocols, digital telehealth technologies, electronic patient reported outcomes (ePRO), and full web and contact center patient support to eliminate the need for in-person office visits.
Thomas Hatch, Director of Business Development at Beech Tree said: “We chose Curavit because of their exclusive focus on designing and executing virtual trials. We needed a company with Curavit’s expertise in this important new discipline of clinical research in order to make this trial possible.” Joel Morse, CEO of Curavit added: “This is a unique opportunity to apply modern trial design and telehealth
technologies to allow patients to participate in this study without the potential risk of traveling to physical sites and to participate from the safety and comfort of their own homes.”
Curavit is a new type of clinical research company that designs and executes decentralized – also called “virtual” – clinical trials. Curavit brings together the world’s leading researchers, enrolls previously untapped and underserved patient populations, applies machine learning algorithms to health and social
engagement information, and leverages leading telehealth, patient data platform, and medical device technologies. Connect: https://www.linkedin.com/company/curavit/
ABOUT BEECHTREE LABS
Located in Providence, RI, Beech Tree Labs, Inc. (BTL) focuses on the discovery and early development of therapeutic agents that address a spectrum of unmet medical needs. The company has an extensive portfolio of patented formulations for products intended to treat such disorders as urinary incontinence, allergies, benign prostatic hypertrophy, anxiety, chronic obstructive pulmonary disease and herpesvirus infections. BTL has conducted over 15 FDA- authorized phase 2 trials and has out-licensed both technology and products.
LEARN MORE ABOUT THIS STUDY
The current FDA-approved Phase II pilot study is taking place in Draper, Utah at Intermountain Clinical Research. Additional sites will open in the future. To learn more about this study:
● You or your doctor may contact the study research staff ( email@example.com ) or call
● Visit the study website: https://www.sickwithcoronavirus.com/
● You can also visit clinicaltrials.gov, the U.S. National Library of Medicine database of clinical studies conducted around the world. ClinicalTrials.gov identifier (NCT number): NCT04522830
Dave Hanaman, Chief Commercial Officer, Curavit