From left: Ulrike Anders, Guido Axmann, Katarina Braune, Marcus Maurer, Zsuzsanna Varga, Alexander Puschilov, Prateek Mahalwar, and Nana Bit-Avragim (All images by Daniel Pasche.)

Towards a Collaborative and Open Clinical Trial Ecosystem

How Digitalization & Patient Centricity Are Reshaping Clinical Research: Insights from a Panel Discussion

Diversity exists in many forms, but at its core involves an array of opinions. Making sense of multiple viewpoints and weaving them together requires collaboration. Doing so yields fruit: we make more societal progress when we innovate together, and healthcare is no exception.

Collaboration was the cornerstone of a September 6th, 2017 Berlin Health 2.0 Meetup entitled, “The Future of Clinical Trials: The Good, the Bad, and the Digital”, which focused on clinical research’s changing landscape. Clinical trials are shifting from a linear model, typically initiated by the pharma industry, to a more system-based entity involving new players.

This is a call for effective collaboration.

The Meetup reflects Berlin Health 2.0’s goal: to create community by uniting multiple stakeholders in support of actionable health innovation. The gathering was the brainchild of Berlin Health 2.0 and a Berlin-based startup, Medicinisto. They invited a wide cast involved in clinical trials: doctors, patient advocates, pharmaceutical leaders, and digital health entrepreneurs.

The panel’s task was to collectively voice how clinical trials can further benefit patients and enhance the medical affairs ecosystem through digitalization and patient-centricity. The panel debated the ongoing remodeling of clinical trials in response to new emerging digital environments, rethinking the role of medical affairs and the healthcare industry, and centrally repositioning (digital) patients.

The event quickly filled to capacity and had a growing wait list. For those who couldn’t attend, and for the broader community, this article shares key points.

Ulrike Anders of Health 2.0 Berlin co-organized this event surrounding clinical trials, with over 70 attendees and a waitlist of nearly 50 more. Photo by Daniel Pasche.
We can view clinical trials as a prism to explore this massive collaborative potential. Why? For two good reasons:
  1. The outcomes of such trials greatly impact health innovations, which in turn affect us all.
  2. Clinical trials are on the verge of involving a whole new set of interesting players, many of whom are in turn, interested in us — our health, our DNA, our habits — basically, who we are.

Global Collaboration is Critical

The first “aha” moment arose from a question posed by panelist, Guido Axmann. He’s the CEO of Medicinisto, whose platform shakes up an old medical affairs model, in which the healthcare industry uses agencies to profile medical experts needed for clinical trial involvement. Instead the new platform allows medical experts and industry to create and manage their own profiles, leading to better collaboration.

“What makes the human species so dominant?” Guido asked. The audience offered up answers like ‘the brain’, ‘the hand’– until someone called out “the capacity to collaborate.”

Panelists Zsuzsanna Varga of Bayer Grants4Apps, Alexander Puschilov of Viomedo, and Guido Axmann of Medicinisto interact with the audience. Photo by Daniel Pasche.

“Now we’re getting there!” he responded. He was referring to insights from a book entitled Homo Deus by Yuval Noah Harari which explores philosophy, human nature, and achievement. Sure, ants and bees collaborate too, but humans level up when we exit our silos and build on ideas together.

And we do it globally.

This human ability to collaborate across the planet is partly what sets us apart from other species. How can we best apply collaboration to the challenges and opportunities of the clinical trial ecosystem?

But Wait, WHY Are Clinical Trials Valuable Yet So Challenging?

Let’s look at the staggering numbers: According to health journalist Tjasa Zajc, there are more than 253,000 clinical studies across the US and 200 other countries. The International Clinical Trials Registry lists the number at 383,000. Take a listen to her insightful interviews on digital health here.

A refresher: At a basic level, clinical trials involve biomedical research studies or experiments in a clinical environment. They are formal by nature, with protocols on feasibility, exclusions and inclusions about recruitment and participants.

Clinical trials help bring new medicines, devices, technology — and now health apps– to the market. One of their main purposes is to drive up more data on safety and efficacy. In other words, they should deliver more effective results, or generate a beneficial impact of drugs, medicine, devices, or mobile apps.

The down side? With varied design methodology and multiple phases –plus the fact that they involve humans — clinical trials are complex. They’re expensive, not necessarily transparent, and pose difficulty in proper patient recruitment, selection, and medical expert involvement. They are time–sensitive and at the end of the cycle, insurers may push for cost-savings and generics, amplifying the pressure on the whole clinical trial cycle itself. What’s also troubling is the risk of cherry-picking, or only looking for positive outcomes.

Unfortunately, the business of clinical trials has mostly been restricted to stakeholders while the broader community remains outside. That’s why it’s worth opening the discussion more widely to collectively remodel this ecosystem.

The panel considers complex questions from Meetup attendees about handling regulations, avoiding hype surrounding digital health, and measuring success. Photo by Daniel Pasche.

Medical Affairs 2.0 Is A Brave New World

As medicine becomes more personalized and data-driven, this complex landscape of clinical trials is shifting from a linear model to a more dynamic network of key players.

The complexity involving players is astounding, acknowledged event moderator Nana Bit-Avragim, a health expert who strategically navigates and orchestrates partnership relations at Medicinisto. That’s partly why the team at Medicinisto built a new network connecting medical experts with the healthcare industry. This shift in envisioning clinical trials is part of what can be called Medical Affairs 2.0.

Medical Affairs 2.0 combines data mining with medical expertise – a vital mix necessary for successful product launches. According to a 2017 report by Bain & Company, as younger physicians shift away from reliance on large pharmaceutical representatives, they seek scientific data collection to shape product development. Doctors with energy to solve problems using innovative ideas will soon have a better way to pitch ideas, collaborate with other key stakeholders, and move forward with trials and products.

The Bain & Company study shows that companies who can communicate science effectively with the growing array of stakeholders that influence purchasing decisions will be more successful. Additionally, a medical affairs team that links scientific and clinical results to patient outcomes will add value at every stage of a drug’s development. As diagnostic tools are becoming more sophisticated and drugs increasingly complex, it escalates the need for more transparent data on drug performance.

Panel member Marcus Maurer, Professor of Dermatology and Allergy at the Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, embodies this mindshift of involving stake holders and increasing data in the clinical setting. He says Meetups like this can change one’s attitude — especially crucial for improving the medical industry’s current reputation.

He reflected on what it means to be a medical expert in the new paradigm, and it comes back to collaboration: Experts can’t exist in a silo; they need a good team behind them, and communication across to other teams. He stressed that real digital solutions – not gimmicks – which track measurements actually useful to doctors, and which go beyond what monthly blood tests or questionnaires can detect, are what matters most.

Medical researchers need better interactions and trial models to help drive patient-centric innovation. He would like to see more digital transformers like Medicinisto.

According to Marcus Maurer, “The way to do this is to listen to our patients…We need to develop ways (tools and platforms) that make it easy for patients to tell us what we need to know…We need to learn from our patients, not just when they are here with us in the office and we can talk to them, but problems they have in daily life, problems they have at home. What are the burdens, what is the impact of the disease? And how does a new treatment, how does a new management approach change that burden in the daily life of patients?”

For deeper insights, listen to his interview on M100 here.

Marcus Maurer emphatically supports listening to patients and being open to digital innovations that effectively measure data which is meaningful to doctors and researchers, including outside the clinical realm. Photo by Daniel Pasche.

How Can Startups Restructure Relationships around Clinical Trials?

As medicine becomes more personalized, data scientists, programmers, and even social media giants will come more into contact with potential industry partners. This area of the Berlin ecosystem is already growing as two pioneering startups challenge clinical trial innovation.

As mentioned, Medicinisto interfaces between MDs and the healthcare industry. Another German startup, Viomedo, now occupies the critical space of recruiting the right patients for the healthcare industry in Germany. Panelist Alexander Puschilov, CEO of Viomedo, suggests that patient-centricity be applied to even earlier phases of clinical trials.

Learn more details by listening to an informative podcast, where Tjasa Zajc interviews the CEOs of these two German startups.

Alex Puschilov from Viomedo explains the importance of connecting patients to the right clinical trials in Germany and beyond. Photo by Daniel Pasche.

So what exactly is patient centricity?

“In the patient-centric model, ‘patient-centric’ means that you put the end user’s benefit, or need, at the core of everything else.”- Guido Axmann

It turns out that the term patient-centricity is not new. In his Meetup keynote address, former life scientist and current manager at EY Germany, Prateek Mahalwar said the term goes back at least to 1969.

In his keynote, Prateek shared how his grandfather’s illness drove him to do genomic sequencing to discover a specific gene mutation, despite not being able to intervene further for his loved one. His sobering anecdote reminds us our life roles overlap: we can be both a patient and doctor, a patient advocate with a great new idea, a doctor and an innovator of digital apps, a pharma representative and a startup scout. This is actually a form of design thinking, to step into another’s shoes in order to come up with solutions.

Prateek Mahalwar delivers an impassioned keynote address at the Meetup. Photo by Daniel Pasche.

We need this mental metamorphosis to see challenges from a new point of view. To the delight of the panel, Nana recommended injecting the role of “Chief Patient Officer” into the German ecosystem in order to more firmly establish the viewpoint and best interest of patients. It is already happening elsewhere. This could strategically help patient organizations get involved in design and planning of clinical trials.

Another aspect of patient-centricity is called digital biomarkers. No longer just a vision, it’s an established concept that companies such as Bayer, Novartis, and Sanofi utilize. These companies develop new biomarkers to track and constantly predict responses to drugs. They can see and track patients using digital biomarkers to remotely monitor situations, checking if a patient gets side effects, and what medication works on whom.

As a recent Rock Health report states: “Individuals who were not ‘patients’ or formally enrolled in clinical research were previously excluded from the data collection processes, but digital tools provide all internet-connected individuals with the opportunity to monitor and track their health status outside the four walls of healthcare.”

Patient-led Innovation: The Case for Hacking Diabetes

Not only do big companies have deep interest in personalized medicine, but patients do too. A worldwide website patientslikeme.com empowers people to consult each other online, sharing physiological reactions to medications. In Berlin, we are fortunate to have a very active online diabetes community who hold Meetups of their own.

At this particular event though, panelist Katarina Braune, a medical doctor and researcher at the Department of Pediatric Endocrinology and Diabetes of Charité-Universitätsmedizin in Berlin offered us her unique angle. She herself lives with type 1 diabetes and goes to work everyday for patients with that condition. She has become a vocal advocate for them.

Some patients go further than creating websites. According to Katarina, diabetic patients often build their own solutions. Just follow the hashtag #wearenotwaiting for examples of patient-led innovation. Some patients with diabetes don’t care about approvals; they hack their own medication equipment to manage their daily insulin, showing surprisingly stable blood sugar results to their doctors.

Katarina Braune discussing patient-led innovation and what we can learn from it. Photo by Daniel Pasche.

Katarina thinks the idea of Chief Patient Officer is a very near reality in Germany, and would not be surprised if more companies here offer such a position. It is clear to her that better research comes from closer collaborations between patient, patient advocacy groups, and industry.

Katarina Braune says the industry can learn from patients, offering a slight smile when saying patient solutions are “not legal, but they are good.”
Marcus Maurer and Katarina Braune of Charité share valuable medical expertise and experience with patient interactions. Photo by Daniel Pasche.

Much-Needed Digitalization

However, Katarina was also clear in her critique: digitization needs to happen in German hospitals. The panel shared her sentiment. The stark contrast between Germany’s health tech innovation and this country’s lack of digitalization in hospitals will at some point reach a breaking point. Just look to Sweden, the Netherlands, and the USA for models of more advanced healthcare digitalization.

Sitting beside Katarina was panelist Zsuzsanna Varga, Innovation Manager at Bayer and Program Manager of Bayer Grants4Apps. Zsuzsanna offered an optimistic outlook on clinical trial reform, lauding so-called baby steps from clinical trial counterparts who recently digitized patient consent forms, as a positive sign. Zsuzsanna pointed to cell simulations for cancer treatment from Grants4apps alumni, Turbine, as well as innovation from her fellow panel neighbor and another Grants4Apps alum, Viomedo.

Zsuzsanna Varga from Bayer Grants4Apps discussing the role of startup collaboration with the pharmaceutical industry as well as strides towards digitalization. Photo by Daniel Pasche

New Players, New Game

More major new players, like Google, Amazon, and Apple, will continue entering the clinical trial ecosystem. Three days after this Berlin Meetup, CNBC technology and health reporter Christina Farr tweeted: “Facebook wants to build a business around clinical trial recruitment.” The article behind the tweet indicates Facebook has been meeting with pharma marketers to determine logistics on how they can either target clinical trial research or certain drugs to specific audiences.

Social media will undoubtedly play a huge role in evaluation and assessment of clinical trials and is therefore an undeniable factor contributing to this new ecosystem. The time to discuss what this looks like is now.

On September 10th, 2017, Apple announced its new iPhone and watch versions. “Is Apple watch going to become a regulated medical device? — asked Christina Farr, while watching the latest Apple show live. The most amazing and obvious fact is that this tech giant now aims to become dominant in the health market and potentially play a pivotal role in health technology assessment.

Future Thinking

This event’s speakers see the future of clinical trials as an open innovation model. Open in a sense that entrepreneurs work with the health industry, a patient with a doctor, a doctor with an advocacy group, and so on. Collaboration is flexible, and no longer follows a linear path from industry to doctor/researcher to patient. We have new players in the clinical trial system, and new connections between stakeholders.

Easier and more transparent ways of partnership are on the way. New platforms are emerging and enabling our progress. Patients can explore and sign up for clinical trials on Viomedo. Innovative doctors can register on Medicinisto to collaborate with the healthcare industry to bring better therapies faster into the hands of patients.

Let’s use this diversity to yield more collaborative healthcare.

Nana Bit-Avragim encouraged a diversity of perspectives and discussion on digitalization and patient centricity. Photo by Daniel Pasche

Author’s Note: Many thanks to Nana Bit-Avragim for her visionary guidance and joint efforts in producing this article.

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