The company monitors trial data in real-time to make sure patient safety, protocol adherence, and patient retention.
OSP asked them a few questions to find out more before the DIA 60th anniversary celebrations begin.
Can you share any new products or services your company is unveiling at this year’s DIA?
Curavit recently launched its Health Economics & Outcomes Research (HEOR) Practice. The HEOR services are incorporated in clinical trials to capture evidence of the health economics value of novel pharmaceutical products, especially within the digital therapeutics (DTx) space, in which companies are striving to accelerate market momentum with new therapies.
Recognizing HEOR is a critical component to all clinical studies. Curavit’s HEOR services uncover economic insights, determine therapeutic value, and surface unmet patient needs. With this insight, Curavit assesses the value and effect of interventions on both individual patients and population health levels of care.
MedRhythms, an early adopter, is working with Curavit to investigate long-term patient adherence, response durability, and healthcare economic value of its novel neurorehabilitation system to improve walking in adults with chronic stroke walking deficits. The study – known as OrcHESTRAS (Outcomes and Health Economics of Stroke using Rhythmic Auditory Stimulation) – is a prospectively enrolled study, with a novel design that focuses on evidence generation and exploration of a product’s impact on reducing financial burden on the U.S. healthcare landscape.
Curavit connected its Stratus platform to both claims and medical data networks, providing a single HIPAA-compliant environment for receiving, reviewing, and analyzing these data sets. Curavit’s clinical research coordinators confirmed claims and medical data availability during the screening process to efficiently incorporate HEOR into the clinical trial. At study close-out, both HEOR and clinical data are then easily analyzed to quantify the financial impact of the therapeutic.
How do your latest innovations address current challenges in the pharmaceutical and healthcare industries?
Most recently, Curavit expanded its platform of digital research tools, uniquely configured for each trial, to manage every aspect of a trial, ranging from operations to data collection and insight, to patient experience. It’s essentially a virtual site. Using the platform, Curavit’s expert clinical operations team interfaces in real time, in the cloud with patients, partners, and sponsors to conduct world-class research. In doing so, Curavit minimizes the need for physical infrastructure and travel, which diversifies patient recruitment, improves data quality, increases trial speed, reduces costs, and ultimately, makes life-changing - and potentially lifesaving - therapies more accessible to populations who can benefit from them the most.
What roles do digital health solutions and telemedicine play in your company's offerings?
Curavit’s virtual site innovation has proven to be a significant benefit to trials, particularly in the digital therapeutics space since the therapies being studied are innately digital.
For example, Swing Therapeutics partnered with us to design and execute a novel virtual site to recruit participants for a clinical trial of an investigational digital therapeutic (DTx) for Fibromyalgia. The hybrid trial began with 25 physical sites and the goal of enrolling approximately 300 trial participants. Seven months into the trial, Curavit was invited to help broaden participant access to the study and enhance diversity, while improving patient engagement. With its digital outreach, Curavit was able to remotely recruit, screen, consent, and enroll participants from hard-to-reach and underrepresented communities across the U.S. over the 12-week trial. By eliminating physical and geographic barriers to trial participation and execution, Curavit enrolled more than 130 participants, on average 10 times the number of trial participants than those recruited from each of the study’s brick-and-mortar sites that started recruiting at the same time. The convenience of the remote trial and Curavit’s digital engagement incentivized more patients to not only enroll, but also to interact more than their counterparts at traditional research sites, as they were able to complete requisite trial activities on their own terms and in the comfort of their own homes.
What major trends do you see shaping the future of the pharmaceutical industry?
On the cusp of the 60th anniversary of the DIA’s Annual Meeting this June, it can be tempting to look back on the industry, but there is so much happening right now that is likely to transform the pharmaceutical industry…and medical care. One trend that Curavit is seeing lately is the rise of companion health apps and software-as-medical devices. Digital therapeutics (DTx) and other digital health products continue to grow even in spite of some hiccups in 2023 after Pear Therapeutics, the largest DTx company, declared bankruptcy.
Large pharmaceutical companies are increasingly embracing digital health products as companions to traditional drug products – especially for mental health. One recent example is Otsuka which, in January, announced the first FDA approval of a digital treatment for depression, co-developed with digital therapeutics company Click Therapeutics. Called Rejoyn, the smartphone-based treatment is intended for use by prescription, alongside antidepressants and cognitive-behavioral therapy.
At Curavit, the bulk of our pipeline are small biotech DTx manufacturers and big pharma companies who are trialing new digital health products as companion therapies to traditional pills. There is great momentum in this area as digital products enable greater access to therapies at more affordable prices, so we think this trend will only accelerate in the coming months and years.