Closing the Loop: Why Digital Therapeutics Are the Future of Clinical Evidence

For decades, clinical trials have been criticized for being "snapshots in time"—episodic, transactional data captures that often miss the holistic reality of a patient’s daily life. Today, the industry is at a breaking point. With a looming $192 billion patent cliff forecast through 2028 and increasing regulatory pressure for real-world evidence (RWE), the transition from episodic care to enduring patient relationships is no longer optional—it’s a strategic necessity.

A promising solution lies in Digital Therapeutics (DTx). These aren’t just apps; they’re evidence-based, regulated software tools designed to prevent, manage, or treat medical conditions. Whether used as standalone Prescription Digital Therapeutics (PDTs) or as Software-Enhanced Drugs (SEDs) that augment traditional medication, DTx represents the next frontier in drug development and patient engagement.

“The life sciences industry is deeply focused on scaling patient engagement and improving patient outcomes, generating real-world evidence to support labeling claims, and battling the massive looming patent cliff. There is, therefore, a critical urgency for pharma to turn to digital therapeutics to lead the way.”

The New Regulatory North Star: PDURS

A major catalyst for this shift is the FDA’s Prescription Drug Use-Related Software (PDURS) draft guidance. This framework allows companies to integrate the added clinical benefit of software directly into an official drug label.

For sponsors, this is a game-changer that offers:

• Strengthened Value: It makes obtaining insurance coverage significantly easier, as approval is required only once for the combined drug-software asset
• Label Extensions: SEDs can differentiate brands and sustain revenue streams even after a drug loses exclusivity (LOE)
• Continuous Insight: DTx systems create a "closed loop," bridging the gap between clinic visits to provide continuous support and generate the RWE regulators now demand

Medidata + Click Therapeutics: A Strategic Powerhouse

Realizing the potential of DTx requires a marriage of clinical rigor and software expertise. That’s why Dassault Systèmes’ strategic investment in Click Therapeutics is so pivotal. By combining Medidata’s robust clinical trial infrastructure with Click’s industry-leading digital therapeutic software, we’re providing sponsors with a clear competitive advantage.

Our partnership is designed to move the needle from R&D to real-world evidence by:

• Accelerating Development: Leveraging the Medidata platform and AI capabilities to speed up the validation and regulatory acceptance of novel digital treatments
• Unified Engagement: Extending the patient experience beyond the trial to encompass the entire care journey through a unified engagement platform
• Scalable Access: Using a smartphone-first approach to reach patients in rural areas or those with language barriers, ensuring trial equity

“We’re entering a world where people are going to know the brands of these pharma companies, they’re going to know the experience that comes with [their therapies], and they’re going to want to be on the treatments that have the best user-friendly, patient-focused experience.”

– David Klein, Founder and CEO, Click Therapeutics

The Path Forward

While the transition to DTx comes with challenges—including varying levels of digital maturity among sites and the need for seamless technical integration—the potential benefits are undeniable. Digital therapeutics are more than just a trend; they’re "game changers" that deliver human-centered experiences and build enduring patient trust.

As we move toward 2027, IDC predicts pharma and biotech companies will double their investments in GenAI-enabled, unified engagement platforms. Medidata is proud to be at the forefront of this evolution, helping our partners turn "snapshots" into a lifelong connection with their patients.

For more insights from IDC, read their latest Spotlight paper: