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 an 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.”
About Blue Note Therapeutics
Blue Note Therapeutics is a prescription digital therapeutics company singularly dedicated to serving patients suffering from cancer. We aim to make treatment accessible to any cancer patient, at any time, by merging deep scientific and clinical expertise, neuroscience, and digital innovation. Working closely with cancer research and patient communities, we are developing a pipeline of clinically validated prescription digital therapeutics to help reduce anxiety, depression, and other forms of cancer-related distress.
About Prescription Digital Therapeutics (PDTs)
Prescription digital therapeutics (PDTs) are a therapeutic class of 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.
Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase’s has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community.
This starts with Curebase’s leading decentralized clinical trial software platform that is an all-in-one, purpose built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the “BYOP” or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials.
We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients’ physical location. COVID-19 tailwinds have created massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide adoption of remote remote research that will only accelerate in the years to come. You can learn more about Curebase and our next stage of growth in Crunchbase, Fierce Biotech, and MedCity News!