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The topic of patient centricity remains very active in the clinical trials industry, as the concept continues to emerge and evolve. The purpose of this Patient Centered Clinical Trials facilitated by our friends at eyeforpharma virtual roundtable is to (a) better understand the definition of patient centricity, (b) uncover challenges associated with industry wide patient centered technology adoption and (c) how patient centricity/engagement technologies will push the biopharmaceutical industry to c
The topic of patient centricity remains very active in the clinical trials industry, as the concept continues to emerge and evolve. The purpose of this Patient Centered Clinical Trials facilitated by our friends at eyeforpharma virtual roundtable is to (a) better understand the definition of patient centricity, (b) uncover challenges associated with industry wide patient centered technology adoption and (c) how patient centricity/engagement technologies will push the biopharmaceutical industry to change.
This panel includes a consortium of digital health innovators including Fabio Gratton, Founder, Alchemy Factory, Co-founder & CEO, CureClick, Abbe Steel, Founder & CEO, HealthiVibe, Tyler Trueg, Director of Clinical Product, TrialReach, and Sean Vassilaros, Partner & COO, Thread Research
What is Patient Centricity?
The panel’s general consensus on defining patient centricity led towards the notion involving ‘walking in the patient’s shoes.’ This would require regular interactions with patients, understanding their needs, and involving them in the development of a new medical product process through post-marketing and payer approval.
Gratton indicated, “it really means not only walking in the patient’s shoes, but also seeing the world through their eyes, and really understanding their needs, which requires interacting with patients, listening to them and truly making them a part of the solutions that we create as an industry.” Vassilaros added, “we strongly believe that the patient needs to be a part of the research process. They have a voice. They feel like they have more responsibility and power to be able to effect change in the world today. So our goal should be to allow them to have a voice, and allow them to craft exactly what should be studied and what’s important to them.”
Trueg elaborated, “we should give them [patients] the power to access this [clinical trial] information and make their own decisions. With the prevalence of the Internet and medical records, and everything going into a lot of technical avenues, it’s really about the access to information and empowering patients to make their own educated decisions, not being gated by traditional models.” Steel said, “from a pharmaceutical company perspective, I think what’s really critical for thinking ‘patient centricity’ is that patients are considered stakeholders as important as prescribers, investigators, and regulators.”
Challenges in Technology Adoption: Stagnant Biopharmaceutical Culture
What clearly came out of this discussion is that biopharmaceutical enterprises lack the ability to implement flexible and fast changing cultures, which is hindering patient centric technology adoption. Additional challenges included integrating patient’s needs (which tend to be simple) into the complex biopharmaceutical clinical setting, and how to leverage big data.
Steel indicated, “I think that really, it’s culture. We see it with companies’ fear of taking risks, fear of hearing about adverse events – we’ve heard all about that with social media concerns – fear of getting slapped on the wrist for off-label discussions. I started working in biopharmaceuticals 25 years ago, and the culture hasn’t changed very much. It’s a challenge when you have legal, compliance, privacy, and regulatory departments that hinder patient centricity efforts.
Trueg added, “We’ve found that the frame is really scientific. How do we make medical terminology patient-friendly? And we’ve run into some challenges where it really comes down to…more of a pragmatic approach: what are you actually trying to accomplish with this trial? It’s not really so much of a ‘let me educate you,’ approach, it’s ‘let me bring you to the table; let’s make this an equal conversation because we both have different perspectives.’ And then going the other direction once we are gathering information on patients or learning insights.”
Gratton explained, “collecting data is not an insignificant challenge; when you collect data, you need to have a means and a process to analyze it with some clear objectives. And just like anything, when you listen, you need to respond and act – that’s the expectation that gets set. People don’t like to just give data; people don’t like to just talk and be in a vacuum if nobody’s going to respond. And so, unfortunately, this is not really built into the clinical trial culture. It’s not built into the operational systems within the clinical trial infrastructure today. And I don’t mean the trial itself, I mean the entire landscape of players – the people who help structure trials and recruit for trials.”
Technology Adoption: Biopharmaceutical Laggards Will be “Left in the Dust”
The panel elaborated on very interesting perspectives regarding how technology will push the biopharmaceutical industry to adapt and change. The introduction of mHealth and personalized data collection will propel the clinical trials industry into a new realm. Enterprises who fail to take advantage of these new technologies will not realize disruptive benefits, such as improvements in clinical trial quality and success rates.
Vassilaros said, “the limiting factor is, how much data is out there and the ability to take that data, analyze it and come up with conclusions. The announcements that doctors want to play in healthcare, that Apple and Google are coming up with research kits and tools that will help take everyday devices and turn them into data-gathering devices and be able to share that with large communities. Researchers are going to have access to real-time data they’ve never had before. So we strongly believe that we’re right at a pivotal point in this entire industry, where technology is going to force those that have thought about research the traditional way to evolve and adapt and take advantage of this technology or else they’re going to be left in the dust.”
Steel added, “as we’re applying different technologies more and more for trials, we are starting to learn about which technologies are best for each type of trial, patient population, age group, disease area, and country. As an industry we need to consolidate and make use of all this learning and move the needle together.”
Gratton concluded, “there’s an element of perspective and curiosity. What I mean by that is that those who are creating new ways of doing things are looking at the world through a different lens. But really their perspectives aren’t like other people in that they are looking to solve problems in completely different ways and they see them as fascinating puzzles that need to be solved. They also bring a different set of tools to the table, first of which I mentioned was curiosity. And so technology without people is nothing more than just wires and electricity. And I think it’s really important to understand that if we don’t marry great people that are passionate about what we are trying to do as an industry with this technology, it’s really not going to be as powerful and impactful as what it can be.”
The panelists will share more of their insights along with Michael Solomon, Head of Healthcare at Google, on October 19-20 in Philadelphia, at the eyeforpharma Patient Centered Clinical Trials Summit. This conference is a key outcome of eyeforpharma’s patient-centered clinical trial initiative, a collaborative research project with the pharmaceutical industry. The agenda will provide you with operational insights, new research findings, high-level debate, innovative pilots, best practices and novel case studies. For more information visit: http://goo.gl/r0QAoX