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Clinical research is radically changing as more and more trial sponsors embrace a decentralized model to solve two fundamental challenges: addressing barriers to clinical trial accessibility and improving diversity amongst clinical trial participants.
At least half of FDA trials in the US are conducted in only 1-2% of zip codes. Low participation in clinical trials remains an issue across research, with less than 5% of the global population participating. In addition, 85% of clinical trials fail to meet their enrollment targets, which is more than three times the number of those that are successful. Of the trials that achieve their enrollment targets, a lack of diversity due to accessibility remains a big issue. If the current clinical research process doesn’t adapt to these changing population demographics, the life sciences industry will continue developing drugs and devices that are only shown to work for a select few, leaving out the rest.
The access to novel clinical trial digital tools creates opportunities for patient diversity in research. As a result, we see a shift from site-centered to patient-centered research, as the industry is proactively engaging with patients in a way that better fits their needs, according to Dr. MaryAnne Rizk, Medable’s Chief Strategy Officer. The goal, says Rizk, is to ensure that we are actively capturing the voice of patients so we create better treatments for everybody. In this interview, Rizk discusses how this shift will manifest in real life.
Moe Alsumidaie: Should all drug development be patient-centric? What are the biggest challenges in clinical research today hindering patient-centricity?
MaryAnne Rizk: I believe decentralized research is the path to all-inclusive medicine for the broader patient population. We get there by creating a more convenient journey for patients that empowers the flexibility of choice for clinical care as an option that is either remote or a hybrid. Medable’s CEO is a practicing physician and brings a fresh perspective with her medical lens to how we reshape patient engagement, affording us a rare opportunity to put technologies in the hands of patients so we can learn what works best for their needs and drive the best results for more all-inclusive treatments.
However, one challenge standing in the way is learning how to evolve the site of the future. We believe sites are fundamental to patient experiences, so we want to enhance their essential role through technology, not replace sites with technology. The future is a hybrid. Some patients will want to engage remotely as much as possible, and others may prefer to do some visits at a local site and some remotely and just one or two at the primary site. In other words, tomorrow’s research site may not look the same as it does today. For instance, it might be a retail pharmacy or community clinic with a central site coordinating care and leveraging advanced technology. Medable is helping to reduce the patient and clinician burden and capture better data by digitizing as much of the research process as sensible.
Data capture is another challenge—and a significant opportunity to capture critical insights from study visits. Thanks to the decentralization of trials, we have a proliferation of data collected earlier and more often from various sources. There are inherent challenges with the sheer quantity and variety of data today. But Medable is driving a radical movement to be closer to patients, modernize sites, and establish a concierge-like service—a consumer-grade experience for patients that makes data insights easier to capture. When we collect patient data before, during, and after a study, we can partner with sponsors on the meaningful use of that data.
MA: How do you aim to increase DCT adoption in the clinical trials industry?
MR: Medable has engaged over one million patients across a myriad of over 5,000 sites globally, operating in 40 countries across 60 languages—it’s a significant start. With the broad expansion of reaching more patients and sites globally, we are advancing the capabilities to make an impact. A flexibly decentralized model needs to enable greater patient access while providing a flexible and seamless experience across all users that improves trial operations and time to treatment.
For example, Medable empowered one precision medicine company to develop new therapies for a rare disease screening of age-related macular degeneration that required a deeper understanding of the disease and cost-effectively screening of 11,000 patients. Our decentralized platform model and direct-to-patient shipment workflow drove a 50% reduction in patient enrollment time and a 75% reduction in study sites, resulting in a $20M decrease in trial costs to achieve the study’s endpoints.
Moving forward, the way to continue to expand the DCT adoption is to design technology solutions that are agile, simple, and elegant—employing human-centered design. A good design is visible, but an exceptional design is invisible. As an example, we’re now seeing improved intelligence to optimize the enrollment period and study startup. We’re getting feedback, not just after a trial but throughout the cycles of a clinical setup. This is important as we’re looking to optimize how we approach our sites, creating programs like our Site Network Council that give us valuable insights to optimize the way they work and create the highest value. To do this, we are creating executive leadership teams at Medable that bring together a rich pedigree of scientific, medical, technology, and design backgrounds to advance how research is conducted from a remote setting.
Second, engaging directly with patients is crucial, and Medable is doing this by nurturing collaborative networks with patient advocacy groups and physicians. Consider the consenting process. Medable’s consent tool ensures patients understand what they’re going to be signing up for, which is critical because the most informed patient is the most engaged patient. As a result, we see up to 90% patient satisfaction.
Lastly, it is critical to up-skill the talent needed for the next generation of the resources necessary to modernize clinical trials. What will a digital CRA or a digital analyst, or an architect look like in a few years? What are some of the things they need to think about when using data, digital technologies, and accommodating patient engagement? The industry should be motivated to champion leaders who will help advance the mission because no one can do it alone. We want to create an ecosystem of partners, sites, patients, sponsors, and CROs motivated to expedite faster treatments.
MA: Will DCTs bridge the racial and economic divides in clinical research? Can you tell me why or why not?
MR: DCTs are changing the future of research. And the two leading critical success factors in terms of the impact of radically advancing clinical research are access and diversity. The convenience of accessing clinical trials within your iOS devices or mobile devices opens us to a world of ubiquitous access—and this is naturally enabling more diverse data sets so that FDA-approved medicines will be as effective to ensure a diverse representation of people from varied economic and racial backgrounds; expanding clinical trial access to many more patients.
Also, today we see a new trend in patient-centered intelligent protocol design, boosted by a digitally focused mindset. The focus on diversity drives industry-wide change that includes widening the net with more access to care.
MA: Why are you passionate about human-centered research?
MR: Human-centered research is about putting the patients first and creating a consumer-grade experience for trial participants. Today we put the letter “E” in front of everything, right? E-consent, E-visit, etc. And because we’re moving through this digital age, you recognize that the patterns needed to improve and impact require understanding and predictive analytics.
If we’re able to advance the way we bring data and insights together, not only for clinical research but also, so patients have access to better care—that is why I’m wildly passionate about human-centered design. We recognize that the impact and the outcome are rich in terms of the unique advantage of improving health care through technologies and data tools.
MA: You’ve worked on E-clinical systems at a range of established enterprises like Merck, IQVIA, and Oracle. So, what inspired you to join a growing company like Medable?
MR: Medable is on a mission to modernize clinical research for the benefit of patients. During the pandemic, I was given this opportunity to go where I could make the largest impact. And when I learned Medable’s vision is to redesign the way clinical trials should be conducted to focus on patients, it was in perfect alignment with my view. Medable wants to create the most intuitive patient experience and build on a true, cloud-based SaaS-enabled technology platform, matching my mission. This is the way to create the most significant impact, with ubiquitous access to care through the modernization of clinical trials. And when we think about what it takes to create this impact, it involves understanding the patient, generating a user community that’s going to provide input on their expectations to create predictive insights on what’s needed for clinical trials.
Additionally, Medable has put together a world-class team of leaders with rich domain expertise, whether you’re in operations, product management, technology, operations, clinical development, patient engagement, science, or compliance. It’s exciting for me to get the chance to work with such brilliant minds for collective drive impact forward.
My role is to find a unique way to develop novel innovation partnerships for a diversified ecosystem. I’m fully committed so that we can intelligently connect patients and sites to advance medical research.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.