João Bocas has been active in Digital Health from its inception. In the preceding years, he had worked in fitness, professional sport, and further healthcare-related fields. This quite naturally progressed into technology and innovation when, a few years ago, he started to help corporate clients with digitizing their health and wellness programs. Presently he works with healthcare, life sciences and pharma providers as well as public sector organizations looking to innovating health services. Bocas is a renowned speaker as a thought leader in medical devices and healthcare innovation, and XPOMET© is honoured to welcoming him to its podium.
XPOMET: What are the current shortcomings in clinical trials?
João Bocas: There are so many challenges when it comes to clinical trials. It is a very complex and highly “processed” activity which represents an immense shortcoming in its own right and reflects that as a practice – in layman’s terms.
I would like to touch on some specific significant challenges:
- time frames and financial burdens of clinical research practices
- overall shortage of research specialists
- highly complex regulations attached to the practices
- increasing complexity of contracts
- lack of local supportive infrastructure
- inadequate research training
- less embracement by stakeholders (i.e. increasing business aspects, high pressure from CROs (Clinical Research Organizations)
- patient recruitment and selection process
- numerous data collection challenges (obtaining medical records, reimbursement frameworks, quality control processes, pay for performance only)
XPOMET: Which methods and technologies are you suggesting for optimization?
João Bocas: Let’s start to use new methodologies regarding patient recruitment. This is crucial if we want to disrupt the existing processes. The aim is to simplify recruiting and make it more effective at the same time. I am a strong believer in solution-based innovation and technologies. We must understand what we’re trying to change and improve, and we must be aware of the intended outcomes before acting. Then, and only then we should start the conversation about technologies.
Technology is certainly a must-have ingredient and an enabler in every industry – pharma, life sciences and healthcare are of course no different. I would like to mention certain pain points of optimization; they include the patient communication processes, patient recruitment, health education, and even reporting and compliance. All of these can be affected by digital solutions such as software platforms, where data can be collated, registering processes and recording of data findings. Many solutions even allow data analysis and data mining, which can be considered supplementary technologies in their own right. I am talking about Cloud Computing (CC), Machine Learning (MC) and Artificial Intelligence (AI).
XPOMET: Which benefits do you see in this context?
João Bocas: I would say that understanding the role of technologies in clinical trial design is extremely important. Innovation is contextual, and only after thoroughly understanding all the different factors and stakeholders involved we can successfully innovate. In terms of benefits, these definitely include saving resources – increasing efficiency while decreasing cost.
Also setting up sustainable frameworks to apply innovation is a very crucial point in moving towards the future. Technological innovation moves fast, and to keep up with the pace is hard, in particular when activities are fragmented. By creating a holistic innovation framework you can ensure a continuous circle of organizational improvement. This will help to preserve a leading position now and in the future. However, it may not directly feel like a benefit as it requires investments over time, expertise and related resources.
XPOMET: Have you witnessed the implementation of these new approaches?
João Bocas: I have seen a few large deployments where technology played a crucial role. In my experience with hands-on projects, a good preparation and the right expertise are key success factors.
In order to avoid common mistakes when implementing new approaches, learning from other projects can provide a “de-risk” type of methodology, reducing risks factors and enabling projects to move forward. In my professional consulting practices, I always encourage clients to think outside the box, looking for current and new needs in the market and considering those while taking measured risks. Otherwise, innovation will not happen.
XPOMET: What are the basic requirements for innovation – and what are the barriers?
João Bocas: Keeping all the stakeholders involved and engaged is extremely important. As an example for this, investigators in clinical trials play an important role, however it’s not always easy to keep a closer relationship with them. In order to innovate effectively and to be lean, it is of the utmost importance to keep these stakeholders involved and engaged, to learn about their needs and how to best facilitate them. I consider this a basic requirement, especially in phase 1, and certainly a potential barrier to innovation when wanting to be successful at the final stages of the trials.
Ensuring the longevity of the technologies is another basic requirement for effective innovation. As we know, technology and innovation are moving extremely fast; making technologies future-proof, interoperable and easy adaptable helps us to create innovations which will still be viable ten years from now.
Barriers to innovation are particularly high in conservative industries. Pharma is such a conservative industry where mitigation of risks and culture are heavily embedded in the DNA of the industry and its organizations. This is therefore a standard barrier that we need to work with – behavioral change playing a key role here. I would also argue that the organizational structures of large organizations do not incentivize innovation. Think of procurement, decision making and low agility as common denominators often encountered in large corporations.
Many experts also defend that the new European Regulation for Clinical trials presents a barrier to innovation. It brings better standards, opportunities for globalization in clinical trials and further benefits. However, for innovation it is not necessarily a good thing. Producing your own clinical data requires much capital and many resources. This turns it into a considerable obstacle which needs to be overcome, in particular for smaller organizations and for start-ups.
There are many more barriers with regards to innovation – I experience them every day. However, I believe that if we address some of the fundamental organizational issues and are open minded, we are halfway there. To achieve innovation, eliminating barriers and creating the ideal environmental conditions to innovate effectively is unavoidable and necessary.
XPOMET: What are the specific roles of care providers, pharma, and medtech?
João Bocas: Each sector and stakeholders group must work together, because the future is about close collaboration. The more the marketplace advances, the more we see that working together is the only way forward as nobody provides all the answers and can be fully self-sufficient.
Care providers, pharma and medtech companies need to understand that their final outcome is the same, even though the individual outputs may differ. The final outcome, all of them want to deliver, is excellent care for the patient in need. Their role in the supply chain may be different, but in the end they are serving the same consumer group. This is why, also throughout clinical trials, these different suppliers should work together and communicate with each other to make the process as efficient as possible. For example, care providers could help with patient selection through sharing data; medtech companies need to supply a system which can analyze and share this data with pharma in order for them to use it for clinical research and trials. The more synergy takes place between these roles, the more efficient the process gets.
A pharma company may work on simplifying their existing processes or trying to achieve shorter trial cycles, on the other hand a medtech company’s focus may be on perfecting a specific data point or improving the technologies in use. In that sense, functions and outputs are different. However, to envision the impact on the patients, consumers or population health accordingly is certainly the role that should be underneath of the actions taken, and be implemented in innovation processes, regardless of the specific angle of the industry stakeholder.
XPOMET: How is the role of patients changing?
João Bocas: The role of the patient is changing very fast today. When in the past mainly healthcare providers where at the center of care, we are now moving to a far more patient-centric model. Giving patients more power over their health increases patient control, engagement, efficiency – this improves the patient’s journey and finally optimizes public health. Therefore the patients should be at the center of the clinical trials and other health innovation approaches, they are the “clients” we are all serving.
We see that people are better educated and are more willing to try out new things, which enables technology to become an extremely powerful “friend”. An example is wearable technology, which is obviously very user-centric as it is worn on one’s body. Its acceptance is growing in many industries, predominantly in healthcare. Now medtech and the pharma industries are also starting to adopt the latest health wearables and clinical wearables; this reflects the maturing process of technology which directly modifies the role of patients. It is assuming the prime role which I think it should indeed have.
XPOMET: How do you envisage processes ten years from now?
João Bocas: This is a fantastic futurist question. I would like to think the unthinkable … which means that basically all processes will be carried out digitally, with little intervention from professionals. Let me picture a scenario: Imagine a world where, as a patient, I receive communication and guidance about a clinical trial or a health procedure assisted by technology, including wearable devices, medical devices, and connected tools. The professional only re-intervenes at the very end, therefore patient empowerment is not a goal or target any longer but the norm. The time is now to create conditions to turn this into reality. Technologies have reached the required maturity whereas adoption modalities have not moved as fast; so we need to close this gap in order to make that vision possible.
XPOMET© has invited João Bocas to its podium to speak about the changing world of clinical trials. The Digital Health expert will outline how no stone will be left unturned in today’s brick-and-mortar world of processes and relationships.
Text by Michael Reiter