by Gualberto Gussoni (President of the Ride2Med Foundation), Sergio Scaccabarozzi (Vice-President of the Ride2Med Foundation), and Massimo Raineri (Business Partner Consulting Clinical at Arithmos Srl)
Wearable devices, mobile apps, algorithms, and digital therapeutics are reshaping the rules of clinical research. But what do terms like Digital Endpoints or Digital Therapeutics really mean? And how ready is Italy to adopt these technologies in a widespread, validated, and regulated way?
We asked Gualberto Gussoni (President of the Ride2Med Foundation), Sergio Scaccabarozzi (Vice-President of the Ride2Med Foundation), and Massimo Raineri (Business Partner Consulting Clinical at Arithmos Srl), professionals with international experience in the sector, to help us explore what true innovation means in the world of digital clinical research. Here’s what they told us.
What does “Digital Evidence” truly mean, and why is it a strategic frontier in clinical research?
The continuous advancement of biomedical research—driven by increasingly complex studies and the development of innovative therapeutic solutions involving pharmaceuticals, medical devices, or medical procedures—has gone hand in hand with the concept of evidence-based medicine. In other words, it is no longer enough to claim the efficacy of a medical solution; such claims must be supported by high-quality data generated either through clinical trials or real-world practice using observational study methodologies.
The concept of “evidence” is crucial, as it forms the basis of clinical decision-making processes (e.g., therapy or treatment choices), with direct consequences for patients. Alongside traditional “clinical” evidence, digital transformation has ushered in a new era of “digital evidence.”
Thanks to wearable devices that can continuously collect various clinical parameters, medicine is evolving from snapshot assessments taken during medical visits to a model in which patient data is monitored throughout daily life. These data can be sent to physicians remotely and, when appropriate, analyzed using artificial intelligence.
For digital evidence to be reliable, the parameters to be measured (digital endpoints) must be clearly defined, and the devices used must be rigorously validated to ensure the accuracy and trustworthiness of the data collected and transmitted.
What are the most common mistakes when integrating digital tools into clinical trials?
The use of digital tools in clinical studies offers clear advantages: real-time, continuous data collection on various clinical parameters; support for decentralized trials; and the potential for remote, risk-based monitoring. These benefits can translate into higher-quality studies that are shorter in duration and more cost-effective.
However, two essential conditions must be met. First is patient acceptability: the tools used to collect data must be non-intrusive, not interfere with daily life, and be easy to use, especially if patient interaction is required. This falls under the broader concept of usability.
The second, equally critical, condition is validation. Devices must go through rigorous validation processes—technical, analytical, and clinical—along with usability testing. This ensures that the data generated is of high quality, acceptable to regulatory authorities, and can be used to generate meaningful digital evidence that can inform clinical decisions.
Digital Therapeutics (DTx) are often seen as “medicine of the future”—but what concrete opportunities exist in Italy today?
Health apps are playing an increasingly important role in the prevention and care of patients. According to data from a recent conference by the Digital Health Observatory at Politecnico di Milano, the most widely used apps are those aimed at improving lifestyle, monitoring clinical parameters, and enhancing treatment adherence. The latter feature is considered important by 66% of patients. However, among people over 65, skepticism and concerns about effectiveness and data reliability persist.
It’s important to distinguish between general health apps and Digital Therapeutics (DTx). DTx are typically based on cognitive-behavioral approaches and serve a direct therapeutic purpose, either independently or alongside pharmacological treatments. From a regulatory standpoint, DTx are classified as medical devices and must undergo clinical validation and CE marking, supported by evidence demonstrating therapeutic benefit.
In Italy, DTx are currently hindered by the lack of a dedicated regulatory framework. A specific law is under discussion in Parliament. Nonetheless, data from Politecnico di Milano show that 60% of physicians are open to prescribing DTx, and about 65% of life science professionals consider them valuable solutions for patients.
Key challenges include increasing knowledge and competence within both the medical field and the broader life sciences sector. For companies, the main barriers are difficulty in calculating ROI and the absence of a clear regulatory environment.
Globally, the DTx market is vibrant: 112 active DTx solutions, with 24 new entries and 5 withdrawals since early 2024. The adoption of specific legislation in Italy could allow the country to become an active player in this highly innovative domain.
Many professionals wonder: “Is digitalizing my clinical trials worth it?” – What clinical and economic benefits make this an almost inevitable choice?
The real question should be: “What am I missing by not digitalizing my trials, my organization, or my company?”
Digital technology is now pervasive in our daily lives and is rapidly becoming essential in medicine and research. However, it’s important to clarify what we mean by “digital.” Digitizing data or documents for management and analysis is one thing. But true digital transformation involves rethinking and redesigning processes around a digital-first model.
In a fully digital environment, processes are designed to enable seamless data and document flow, driving automation and efficiency. It’s not just about technology (software, platforms, cloud solutions); it’s about people—their culture, mindset, and digital skills needed to design, manage, and sustain digital processes.
Digital ecosystems are also ideal for leveraging artificial intelligence, as they provide unified, structured environments where AI can deliver real impact.
Despite some progress, clinical research still has a long way to go in embracing digital transformation. The field suffers from a lack of strategic alignment, standardization, and unified goals among stakeholders, including regulators, pharma and medtech companies, CROs, and clinical sites. Procedural inconsistency across entities increases complexity and reduces sustainability.
Current inefficiencies—such as paper-based workflows, duplicated efforts, and the underutilization of integrated digital tools—lead to longer, costlier studies. These costs inevitably influence drug development timelines and market prices.
If you had to convince a skeptical company to adopt Digital Endpoints or DTx, what would be your strongest argument?
We are living through a historic transformation—one that will fundamentally reshape our future. This change is fueled by digitalization and data, which in turn power another key force: artificial intelligence.
The adoption of digital endpoints is inevitable. Continuous data generation, collection, and transmission will enable personalized medicine, digital twins, and disease and treatment simulations—faster and more effectively, to the benefit of patients.
Digital Therapeutics are part of this evolution. Their true potential lies in empowering patients to manage their own behaviors and influence their health outcomes through digital technology. While Italy may be slightly behind in this field, this should not be a deterrent—it’s an opportunity to stake a claim in a still-emerging global market.
Conclusion
Digital innovation in medicine is no longer a distant prospect—it is already underway. As often happens, technology is advancing faster than culture and regulation. That’s why vision, competence, and open dialogue are essential.
For professionals in the life sciences, the time for observation is over. Now is the time to understand, decide, and act.
With its training programs, LS Academy offers a concrete opportunity to deepen your knowledge of the tools, strategies, and implications of digital technologies—while engaging with experts who are actively shaping the future of clinical research, one step at a time.