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Curebase, a company committed to democratizing access to clinical studies, and Blue Note Therapeutics, a prescription digital therapeutics (PDT) company dedicated to easing the burden of cancer and improving outcomes, have announced a collaboration on a virtual clinical trial that will study the effectiveness of two digital therapeutics. Both digital therapeutics are anticipated to have an impact on mental and physical health when used adjunctively with multidisciplinary oncology care regimens.

The goal of the joint trial with Curebase is to maximize our recruitment efforts with patients experiencing cancer-related distress and who may benefit from a fully virtual trial, including home-based subjects who can’t or wouldn’t want to travel to a trial site. This will enable Blue Note to access patient populations that have been underrepresented in traditional site-based clinical studies. People with cancer and interest in this virtual trial can learn more here.

Curebase’s decentralized clinical trial (DCT) platform will be used to recruit participants, screen, consent, and then help guide them through the reporting and activities required for the study. Curebase will utilize its extensive virtual site operations and study management to execute the study. Blue Note is recruiting 353 patients for the fully remote trial, which will begin in early March. The data from this trial is expected to support Blue Note Therapeutics’ future regulatory submissions to the U.S. Food and Drug Administration.

“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 is exciting as it 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.”

Curebase’s DCT model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included. The company’s virtual research sites also provide physicians with new and unique options 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.”