June 28, 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.
BOSTON, June 28, 2022 /PRNewswire/ — Curavit Clinical Research, a virtual contract research organization (VCRO), has been selected by digital therapeutics company, Swing Therapeutics, to be a virtual site for its pivotal trial of an investigational digital therapeutic (DTx) for fibromyalgia. Curavit will remotely recruit, screen, consent, and enroll participants in Swing’s PROSPER-FM randomized clinical trial from across the United States. Curavit will then manage participants throughout the 12-week clinical trial. By eliminating physical and geographic barriers to trial participation and execution, Curavit can scale quickly and improve patient enrollment by at least 10x over a traditional trial, speeding trial execution.
Fibromyalgia is a chronic and debilitating pain condition that affects more than 10 million Americans. It is characterized by widespread musculoskeletal pain often accompanied by fatigue, sleep, memory, and mood disruptions. Swing developed its digital therapeutic with the goal of providing an accessible behavioral therapy option that can be used alongside medication, physical therapy, and other standard-of-care treatments.
“We are focused on getting patient recruitment right,” said Mike Rosenbluth, PhD, Chief Executive Officer at Swing, which recently announced a $10M Series A funding round. “Curavit’s virtual services model enables us to efficiently recruit participants representative of the entire patient population. It solves a huge challenge and will be critical to rapidly develop the evidence needed to bring an effective digital therapy to millions suffering from chronic illness.”
Swing marks Curavit’s 10th DTx client signed in less than six months, a trend in line with a booming global DTx market projected to hit $13.1 billion by 2026, up from $3.4 billion in 2021. Curavit’s decentralized clinical trial (DCT) expertise makes the company well-suited to support prescription and non-prescription DTx studies. Fundamentally, there are no physical logistics with a DTx – no shipping, storing, chain of control, cold storage, or biohazards, plus endpoints can often be captured within the DTx application itself, naturally aligning DCTs with DTx studies.
“Swing is committed to developing scientifically backed digital treatments and evidence to clinically validate their use in the real world, making representative patient participation critical,” said Joel Morse, co-founder and CEO of Curavit. “Our operational model prioritizes patient recruitment and removes geographic boundaries to expand the pool without the expense of physical infrastructure. With zero physical site visits, too, patients are less burdened and more likely to stick with the trial the duration.”
Curavit Clinical Research is a full-service, virtual contract research organization (VCRO), focused on designing and executing digital-first decentralized clinical trials (DCTs). Founded in 2020 by experts with decades of experience in technology and clinical research, Curavit leverages emerging technologies in digital health, cloud computing, and data science to recruit, engage, and monitor diverse patient populations without borders, and bringing trials to patients in the cloud. Curavit’s digital-first DCTs improve timelines, reduce costs, yield real-world data, and increase patient access for therapies more effective across representative populations. Visit www.curavitclinicalresearch.com.
SOURCE Curavit Clinical Research