Digital therapeutics are reshaping modern healthcare by integrating software with rigorous clinical science.
At the forefront of this transformation is Click Therapeutics — a company that has steadily built a platform leveraging neuroscience, neuromodulation and data-driven technologies to create prescription-grade digital therapeutics.
Recently, the FDA released a draft guidance on Prescription Drug Use-Related Software (PDURS), a regulatory milestone that underscores a commitment to advancing the clinical rigor of digital therapeutics.
Chief Medical Officer
Click Therapeutics
This development goes hand-in-hand with Click Therapeutics’ vision for a future where innovative digital interventions complement traditional therapies, enabling personalized and adaptive patient care.
In a recent interview with Xtalks, Dr. Shaheen Lakhan, Chief Medical Officer of Click Therapeutics, provided a comprehensive overview of the science driving these novel therapies and the evolving landscape of clinical research in digital therapeutics.
His insights, rooted in robust clinical standards and advanced neuromodulatory techniques, offer a clear perspective on how this emerging field is addressing unmet patient needs while laying the foundation for the next generation of treatment modalities.
Xtalks Clinical Edge™: Issue 4 — Click Therapeutics’ Approach to Digital Therapeutics
Xtalks Clinical Edge™ is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.
Prescription Digital Therapeutics: Science and Evolution
Prescription digital therapeutics (PDTs) represent a new class of treatments that use mobile applications to deliver therapeutic interventions directly through smartphones.
“In essence, it is using what everyone pretty much has either in their pocket or in their hands, a smartphone using applications that sit on their smartphone to either treat, manage or prevent a disease or condition. This is basically software as medicine,” explains Dr. Lakhan.
This concept is developed through a collaborative process involving scientists, physicians, engineers and product specialists — working closely with patients — to ensure that these interventions are built with the same clinical rigor traditionally reserved for drugs.
Historically, medicine has undergone periodic revolutions — from small molecules to biologics and, more recently, to cell-based therapies and genomic editing. Today, Click Therapeutics represents the next wave, often referred to as PDT 2.0. This evolution moves beyond conventional behavioral interventions and cognitive behavioral therapy to incorporate neuromodulatory techniques and artificial intelligence (AI).
This shift is about harnessing the brain’s neuroplasticity through targeted exercises and digital interventions that personalize treatment for each patient.
By integrating advanced technologies, PDT 2.0 not only mirrors traditional drug development through controlled clinical trials evaluating efficacy, safety and tolerability, but it also leverages the flexibility of digital platforms to adapt interventions in real time. In doing so, these therapies pave the way for a more dynamic and personalized approach to patient care — blending clinical rigor with technological innovation.
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