4 Questions About A Digital Therapeutic Clinical Trial
By Dan Schell, Chief Editor, Clinical Leader
On April 1, Otsuka and Click Therapeutics announced a first: Rejoyn (formerly known as CT-152), which was designed for treating symptoms of major depressive disorder (MDD), had been approved as an FDA-authorized medical device requiring a prescription. “Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression,” said Brian Iacoviello, Ph.D., assistant professor, department of psychiatry, Icahn School of Medicine at Mount Sinai, scientific advisor at Click Therapeutics and a co-inventor of Emotional Faces Memory Task (EFMT). This clearance came after Otsuka and Click collaborated on the Mirai study, a 13-week trial involving 386 participants diagnosed with MDD.
I wanted to know more about how clinical trials involving a digital therapeutic differ from a small molecule-based trial, so I reached out to Tim Peters-Strickland, SVP, clinical development & medical affairs at Click Therapeutics, who also previously had worked at Otsuka.
What is different when designing a clinical trial for a digital therapeutic vs. a traditional pill in a bottle?
Peters-Strickland: The same basic principles apply whether you are designing trials for a pharma product or a digital therapeutic, including assessing efficacy, safety, and tolerability. However, when designing for digital therapeutics, you do need to be mindful of nuances such as iOS/Android software versioning, user experience testing, human factors testing, and simplicity of language, which must be addressed for each specific patient population you are working with.
Does having a DTx component make it easier or harder to decentralize a clinical trial?
Peters-Strickland: It is easier to test digital therapeutics in a decentralized trial because software enables you to monitor progress across a study and engage with patients through more frequent touchpoints via their mobile device. This is one of the main benefits of testing digital therapeutics as compared to molecules, which is why decentralized trials are such a focus for us.
How is tech support best accomplished for both patients and the site during the trial life cycle?
Peters-Strickland: We provide internal tech support for all of our studies. We also have successfully deployed decentralized trials in neuroscience (depression, schizophrenia, migraine prevention, fatigue in multiple sclerosis), oncology (fatigue in breast cancer), dermatology (itching associated with atopic dermatitis and psoriasis), and more. From the patient and site perspective, technology can be viewed constructively (facilitating data collection, ease of use) or destructively (concerns about confidentiality and misuse of data), so it’s important that we work to deliver a positive experience for patients participating in research.
What concerns do treatment providers and patients have when faced with a trial that involves a DTx?
Peters-Strickland: Providers and patients alike ask questions about the efficacy of the DTx, risks, and how the technology can be integrated into a patient’s treatment for their condition. For example, providers may ask: “Will this app really help my patients with their illness or symptoms? How does this app work?” Providers have questions about the technology details, inputs, outputs, potential benefits, and risks. On the other hand, patients may ask: “Will this app really help me with my illness? How will this help me?” Patients have questions about the time commitment, effectiveness, cost, and duration of treatment.