Improving patient engagement in clinical trials and standard practice through empathic AI

Alessandro Monterosso

Cofounder & CEO of PatchAi

Fabrizio Bellina

Marketing and Customer Innovation Manager, Roche

Improving patient engagement in clinical trials and standard practice through empathic AI

17 March 2021 | 10min

Quick Takes

  • Accurate assessment of medicines or interventions in clinical trials relies heavily on patient engagement, for instance following and adhering to protocols as well as thoroughly reporting outcomes

  • PatchAi arose out of the need for improved communication, engagement and a better overall experience for patients enrolled in trials

  • Solving current healthcare challenges with a digital solution requires collaboration, customization, ability to integrate into existing healthcare IT systems, and patience among others

Digital transformation promises to revolutionize healthcare. But, there is a risk in digitizing processes that do not consider patient engagement or experience with these new tools. There is a risk in digitizing for the sake of digitizing. 

Alessandro Monterosso cofounded PatchAi with the aim to revolutionize clinical research and deliver the best possible patient experience and outcomes through the use of a  Companion – an empathic virtual assistant for patients.  We sat down with Alessandro and Fabrizio Bellina, Marketing & Customer Innovation Manager at Roche, to learn how this startup is bringing empathy to a digital world to drive transformational change in healthcare.

Keeping the patient at the center

HT: What made you decide to start your business, what was the problem that you saw in healthcare that you wanted to solve and why?

Alessandro Monterosso: The idea of PatchAi started around 2016, when I was working as a clinical research nurse conducting sponsored trials at the University Hospital of Padua. I felt the need to communicate better with patients in between visits. I was therefore using a lot of messaging apps like WhatsApp, and patients were comfortable in communicating their patient-reported outcomes (PROs) through this tool. This way, I was able to care for them more and they felt cared for at the same time.

At that point, we were collecting most of the data through pen and paper or outdated tech solutions. I was looking for something that I would be able to implement in my daily job, but I couldn’t find anything. That’s how the idea of PatchAi came.

How PatchAi delivers and enhances patient engagement in clinical trials

HT: What impact do you expect your solution to have on the delivery of healthcare or conducting clinical trials?

Alessandro Monterosso: Clinical trials have a lot of complexity, which has risen considerably in the past 10 years. And there is a trend towards lower success rates and patient engagement.

Traditionally, when you talk about clinical trials you talk about enrolling subjects. Sometimes, patients refer to themselves as feeling like lab rats. The process can become so complex with so many questionnaires to fill and so many procedures that patients experience disengagement, or clinical trial fatigue.  

Almost half of patients don’t take the therapy as prescribed and one out of three patients drop out of the study, or they’re pushed out because of some exclusion criteria.

Thus, the idea of PatchAi arose to improve the patient engagement, experience and health outcomes while supporting healthcare companies to offer faster, safer and more personalized drugs and improving the efficiency of clinical trials.

Partnerships are needed to successfully drive digital solutions into standard practice

HT: What partnerships are needed to successfully drive this type of solution into a standard practice?

Fabrizio Bellina: Digital transformation in healthcare proceeds so slowly. Within healthcare provider organizations, we need to change some behaviours, not only at the clinician’s level, but at the ecosystem level. This means that we need to involve external figures at the account level that are able to map the workflow at the hospital and understand what kind of impact a digital solution can have.

Within pharma companies, we must shift our mindset as well. Startup entrepreneurs like Alessandro are passionate about solving challenges and we need to understand how to match visionary startups with a problem that our customers are facing.

Alessandro Monterosso: Absolutely. It’s through the agility and flexibility of a startup, and the experience and the assets of a large industry company where this kind of collaboration can arise to be successful.

One of the major barriers in this kind of cooperation is actually what Fabrizio said, that large corporations tend to treat the startup as a vendor and enter in the classic procedures of purchasing. This doesn’t work for a startup.

If you just think about the accreditation process, that is quite simple for a structured company, but for a startup, it’s almost impossible and requires a lot of effort and money.  It sometimes happens that the startup dies while waiting for the bureaucratic part of a partnership signature with a corporation.

Rethinking traditional ways of working

Fabrizio Bellina: The joint venture is an exploration project, not an exploitation project.

In the future, it could be very useful to find someone that invests in exploration projects. This would mean that we don’t put the cost of development of an asset like Smart Health Companion in the operating margin at the affiliate level. Rather, an investor that trusts in the collaboration between the corporation and startup invests in the development of a solution, including the studies to create the evidence needed for our customers to use and adopt the product.

Main challenges in getting a digital solution into the hands of users

HT: What are the main challenges that you’ve faced in getting this digital solution into the hands of the users? What’s the mindset you have to change in order to be successful?

Alessandro Monterosso:  First of all, for a digital solution, especially in southern Europe, the market is not yet as ready as in other pan-European or US markets, For example, in certain hospitals, in certain regions, you might bring and offer a solution, such as Smart Health Companion but maybe the doctors don’t have access to cameras or headphones, and this represents a barrier.

Beyond this, there is a literacy and awareness problem as to what digital health solutions can bring. It’s the common story about the chicken and the egg – in order to bring a new digital health solution to the market, you need to build evidence, but then, without adoption, you cannot build evidence. So where do we start? With the evidence or the adoption?

Fabrizio Bellina: From a corporate perspective considering this type of a business case, the first barrier especially in Italy is the regulatory oversight. Smart Health Companion is a class one CE mark medical device. In Italy, there is not only the literacy at the clinician level, but also the regulatory oversight in terms of government affairs in the field of health and the ministry of health. They don’t understand what the potential impact will be with a prescription app.

The second barrier is evidence generation. There are a couple of very good articles that were published in Nature that describe this challenge.1,2 One argues that you cannot study the impact of a digital app or a digital ecosystem in a manner that you use in pharma.1 There is a paradigm shift towards new, faster ways of generating evidence for the impact of digital apps. 

The third barrier is related to the operating model that is used to promote this type of app. We move in a digital patient support program and sometimes our field force may not have the skills to use the app effectively. Consider that we train in July ready to promote this app to more than 100 customer-facing roles that now have to educate the doctor, not only the drugs, but also the digital solution. And maybe in only three months, they don’t have the competencies to explain and be more efficacious like on the drug.

Transitioning to value-based healthcare using patient-reported outcomes and clinical outcomes

HT: What are the main challenges with collecting patient-reported outcomes?

Alessandro Monterosso: This is a key question. One of the problems is that, especially with chronic disease, we’re talking about a pool of patients that are predominantly elderly. A related issue is patient engagement. Imagine an elderly person trying to fill this boring long questionnaire on pen and paper or in a digital solution.

However, even the elderly feel comfortable in using everyday messaging tools like WhatsApp or Facebook Messenger. Therefore, we built an empathetic virtual assistant that talks to patients like a friend would do on WhatsApp and we use machine learning to adapt this persona to the patient’s preferences and needs.

In doing this, the Smart Health Companion can ensure the data collection of patient-reported outcomes in a matter of seconds, and this is available in real-time to healthcare professionals.

Fabrizio Bellina: This is a crucial question and is a question that we pose before we start any type of project or collaboration in the future because value-based care has a triple aim goal.

  1. Enhance the patient experience
  2. Improve health outcomes
  3. Control and reduce costs

The secret ingredient to high patient engagement

HT:  You have mentioned ‘intuitive’ a few times and heard ‘authentic conversations’ and ‘empathic’, can you tell us exactly what does that mean and why is that important?

Alessandro Monterosso: One of the most important aspects for a project to be successful when it comes to digital health is involving the stakeholders that use the application where the unmet need is. At every step of the software design and development, patients are actively involved in order for us to understand what they really need, how they’re going to use it, and we keep testing the usability and acceptance of our solution.

HT: From your experience, what advice would you give to large industry players and/or hospitals who wish to work with startups to solve current healthcare challenges with a digital system?

Fabrizio Bellina:

1 Collaborate: From design to implementation, startups, corporations and the health system have to work together.
2 Ensure your system can integrate into the healthcare IT ecosystem: Some healthcare providers require that the data from Smart Companion, for example, be interoperable with the hospital information system. If considered early on, this helps save time at the implementation phase.
3 Ensure data privacy and terms of use and conditions with partners you are collaborating with are clear: We must operate fast and we are learning even faster and continuously adjusting. When partnering with other startups and companies, ensuring it is clear who stores and manages the data early on is imperative. This can also potentially accelerate the progress to some degree.
4 Generate evidence: Show that your solution has measurable, positive impact(s) to ensure the trust of users.
5 Be patient: It doesn’t all come together in three months, it’s an iterative process where we generate results, customize, and adjust.

Alessandro Monterosso is the cofounder and CEO of PatchAi, the first ever empathetic AI-powered virtual assistant for collection and predictive analysis of Real World Data in Clinical research. He was included in the 2020 Forbes Italia Young Leaders Under 30.

Fabrizio Bellina is the Marketing and Customer Innovation Manager at Roche Italy where he helps the teams to listen to the Italian health system in order to co-design innovative solutions that go beyond pharmaceuticals. He has spent 13 years in sales, marketing and strategy in Pharma and Diagnostics, also globally. Obsessed by Design Thinking Innovation in order to drive business model transformation and define new Value Propositions to reach tangible business outcomes.


  1. Shaw et al. (2018). npj Digital Med 1, 48. Article available from [Accessed March 2021]
  2. Guo et al. (2020). npj Digit. Med 3, 110. Article available from [Accessed March 2021]