With this partnership, the VCRO intends to see greater trial enrollment completion rates.
This partnership puts patient-centric lab testing at the forefront as ixlayer provides multiple testing formats like the opportunity for patients to self-collect at home, through a mobile phlebotomy service, or at a local patient service center, according to the companies.
Pouria Sanae, Chief Executive Officer and co-founder of ixlayer, said: “Lab testing is an integral part of most clinical trials but can burden patients in traditional settings. At ixlayer, we reduce friction for patients and sponsors by digitally simplifying the process and streamlining data collection on the backend.”
Curvait and ixlayer anticipate that these additional modality sample selection options will improve patient retention doing the duration of the trial.
Curavit and ixlayer’s first collaboration is for Swing Therapeutics’ trial of a digital therapeutic (DTx) to treat fibromyalgia. The 300 person trial, PROSPER-FM, began in February and will enroll at least 80 participants through which will be remotely recruited and screened. Curavit will use ixlayer’s platform to streamline clinical urine tests to determine participant eligibility. Tests will be conducted at 18 local lab sites across the US, and scheduled through a tele-visit screening from Curavit through its virtual site platform.
Joel Morse, co-founder and CEO of Curavit said that through this partnership with ixlayer, “We are setting the foundation for a frictionless patient experience in our decentralized clinical trials and greater trial accessibility.”
Outsourcing-Pharma previously reported that as a developer of digital therapeutics particularly smartphone apps that support self-management skills, Swing is well-positioned to realize the benefits of virtual clinical trials. CEO of Swing, Mike Rosenbluth previously told us: “Our goal is to make it easier for people with chronic conditions like fibromyalgia to access digital therapies and making the trial available to participants remotely helps us to make that possible.”
Decentralized clinical trials (DCT) such as the Swing Therapeutics trial are projected to increase about 10% over the next 10 years, according to Dave Hanaman, co-founder, president, and chief commercial officer of Curavit. Additionally, Precision Reports reported that the DCT market’s estimated value is $1.63b USD by 2027, an annual growth rate of 14.8%.
The primary endpoints of the clinical trial in which Curavit and ixlayer are collaborating on are the revised Fibromyalgia Impact Questionnaire total score and Patient Global Impression of Change. These endpoints assess the health status of fibromyalgia patients and evaluates all aspects of health to track changes in clinical status.
Lab results, payment, and administrative work will be managed by ixlayer in an effort to create seamless early-trial experience.