Clinical trials software and remote study management company Curebase announced late last week that it will collaborate with prescription digital therapeutics (PDT) company Blue Note Therapeutics on a virtual clinical trial of two of Blue Note’s therapeutics. The digital therapeutics in the study are aimed at improving both physical and mental health of oncology patients, when used in conjunction with multidisciplinary oncology care regimens.
PDTs are a new class of therapeutic medical devices that use U.S. Food and Drug Administration (FDA) approvable software to treat diseases and conditions, such as anxiety and depression related to cancer diagnosis and treatment. Similar to prescription medicines, PDTs must demonstrate safety and efficacy in randomized clinical trials prior to their approval by the FDA.
According to Blue Note, Curebase will help the PDT developer maximize patient recruitment and enrollment in the trial by identifying cancer patients who may be undergoing cancer-related stress who would be open to participating from home, thus alleviating them of the need to travel to a trial site.
“Patients living with cancer frequently experience stress, anxiety, and depression. For many, these symptoms have heightened during the COVID-19 pandemic with healthcare restrictions and disruptions in cancer care,” said Geoffrey Eich, CEO, Blue Note Therapeutics. “Our collaboration with Curebase … brings together our unique capabilities to expand our reach in recruiting for this new, fully virtual clinical trial. Using the latest in digital technology, we’re now able to offer patients a convenient way to participate and what we hope will be improved physical and mental health.”
In the collaboration, Curebase will recruit, screen, and consent participants and provide the tools to them for any reporting activities they need to perform during the trial via its decentralized clinical trial platform. The goal is to recruit 353 patients for the fully remote trial, which is expected to begin this month. Data from this trial will be used to support Blue Note’s future regulatory submissions to the FDA.
According to Curebase, its DCT model helps provide greater patient diversity in clinical studies because these it is easier to include these typically underrepresented populations. The company’s virtual research sites also provide physicians with more clinical trial option to offer their patients, regardless of location.
“People who have been diagnosed with cancer not only deal with this disease on a physical level, they also frequently struggle with depression and negative thought patterns,” said Tom Lemberg, CEO and founder, Curebase. “We’re hopeful this trial will demonstrate that people with cancer can effectively get relief from their emotional distress within the comforts and convenience of their own homes.”
