Medable, a provider of decentralized clinical trial software, credits the clinical research industry’s collective pivot to adapt to the COVID-19 world as a factor behind its growth in the first half of 2020. With many life-sciences firms shifting their trials to digital platforms and incorporating decentralized technologies, the company added numerous customers, took on new and expanded partnerships, and reportedly increased revenues by more than 400% compared to a year prior.
Outsouring-Pharma (OSP) recently discussed the dramatic changes in the decentralized trial market with Medable CEO Michelle Longmire (ML), the company’s growth trajectory and what might lie ahead for the trial industry in the face of ongoing adjustment to the pandemic.
OSP:Please walk us through some of the changes that have happened at Medable.
ML: The past 12 to 18 months have been a breakout period for Medable, fueled by an expanding decentralized trial ecosystem of CROs, sponsors, and partners. Medable grew its revenue by more than 5X year over year and secured more than 20 life sciences customers in 2019, including two top ten global pharma companies and leading medical centers including University of Pennsylvania and University of Connecticut.
To date, Medable has provided the digital infrastructure to expand patient access to clinical trials and improve data quality for clinical trials across 24 countries in 20 languages. This includes both virtual and hybrid trials for a broad range of treatment areas, including oncology, dermatology, neurology, endocrinology and antivirals.
Medable has driven the decentralized clinical trial (DCT) ecosystem forward by introducing new technologies and expanding its partnerships. For example, Medable launched the first mobile TeleVisit application this year, co-developed and deployed with PPD, to enable continued clinical research amidst COVID-19 challenges.
Medable also established its Patient Advisory Council, a nationwide network of advocates who advise us on ways to improve patient access, experience, and outcomes in clinical trials, to ensure the patient is the top priority in all of our solutions and services. Finally, Medable expanded or created strategic partnerships with top clinical development companies such as PPD, Covance, LabCorp, Datavant, MRN, AliveCor, and more.
OSP: How has the clinical trial industry evolved in the months, leading up to the arrival of the COVID-19 pandemic?
ML: The industry has been steadily evolving and carefully considering how and when to best leverage new technologies, tools, and data sets at different levels of maturation. For instance, many sponsors have launched their first decentralized trials in the months after COVID-19’s onslaught; however, these were far from mainstream.
More life sciences organizations and regulatory agencies have also started to accept real-world data for real-world evidence in clinical trials and have begun applying machine learning technologies and artificial intelligence to large data sets to more quickly uncover useful patterns that improve trial design, patient recruitment, and evidence generation.
At the same time, the industry has worked to grow more patient-centric by utilizing digital tools to provide greater choice for patients. Digital is now everywhere – from clinical to commercial.
At Medable, we see that digital technologies like our Patient App and TeleVisit applications are accelerating the adoption of DCTs. These technologies are becoming a necessity with the pandemic closing many physician offices and treatment centers. Travel constraints have also accelerated the requirement for digital options to connect sites and patients with secure, connectivity in remote locations.
OSP: How did the pandemic impact the industry’s attitudes toward and use of decentralized trials?
ML: Without a doubt, COVID-19 has accelerated DCT adoption by five years. Trial sponsors have embraced this departure from traditional randomized trials much faster than expected, even as this new model became essential for patients that are now homebound.
As more sponsors, sites, and physicians as well as patients become increasingly comfortable with digital technologies, wearables, telemedicine, and DCT platforms that bring all of these elements together, the fast pace of adoption will continue. DCTs are the key to improving patient access and their trial experience, which in turn will drive greater enrollment into trials; addressing this challenge that has slowed the execution of trials and added to trial costs for many years is a top priority for many sponsors.
Finally, since DCTs naturally enable more unbiased patient enrollment and participation, they also help eliminate the issues resulting from racial bias in clinical development. Ultimately, DCTs make clinical development more cost-effective while allowing life-saving drugs to get to more patients faster.
OSP: Can you share what you believe are the factors contributing toward your growth in 2020’s front end? Feel free to mention anything, from the pandemic, to tech innovations, partnerships you’d mentioned in your announcement, etc.
ML: Medable is working to create a robust DCT ecosystem of CROs, service providers, and technology companies to bring all of the many elements needed for success together seamlessly. This ecosystem will provide the combined knowledge and solution is key to our success now and will ensure that DCT’s are adopted faster and across a broad array of therapeutic areas and indications over time.
In addition to the highlights above, Medable’s partnership (News out May, 2020) with LabCorp/Covance has significantly helped drive recent growth. Covance expanded its decentralized trials technology ecosystem through an alliance with Medable.
The Covance patient and site interface is now powered by Medable’s modular software platform, providing immediate access to applications that will allow patients to participate in decentralized clinical trials. The platform will also enable data and system interoperability; and facilitate remote data collection and engagement between patients, sites, and clinical investigators. Medable’s unified DCT platform links with other systems for a single system that is less cumbersome for users and patients.
Medable’s patient-centered vision and physician-led strategy resonate with clinical trial leaders, who need a unified technology platform to manage virtual and hybrid trials with agile modules to complement existing trial processes and expectations.
OSP: What changes need to happen in clinical trial culture to make adoption of decentralized and hybrid trials more smooth and effective—i.e. training, upgraded informational infrastructure?
ML: Within the clinical trials paradigm, enabling digital tools to support the physician/clinician relationship with patients is key. For remote trials it’s the foundation to providing consistent, scalable and effective modules to facilitate connectivity.
Traditionally recognized clinical endpoints and measures have largely relied on collection through face-to-face interaction. So, the ability to collect and monitor a patient's health, and provide that data to the overseeing clinician in real time, is transformative.
As we evolve, the ability to develop comparable and new digital and remotely measured endpoints that are acceptable to regulators will be key. The regulatory standards and expectations for clinical trials have been predicated on in-person interactions, such as wet ink signatures. Digital offers the opportunity to support new, global unified standards that enable more choices and accessibility for patients and accelerate the clinical drug development process.
OSP: How can Medable help clients make the transition?
Here are five steps to guide successful risk-based DCTs
- Document a specific decentralized study design and implementation plan, including all patient safety, data integrity, and regulatory considerations.
- Determine the wearables and devices that are needed, what tools are already being used in the study ecosystem (i.e., interactive response technology, electronic data capture, central labs, etc.), and other types of support that would be needed (i.e., home health nursing, local labs, etc.).
- Evaluate how decentralized data will be reviewed and monitored to ensure quality and integrity. For example, define which data are collected for remote patient safety oversight monitoring and which for study endpoint analysis.
- Equip all sites for success in a decentralized model, considering how it will impact efficiency and daily operations. Map out the options that would be best for each site, including those that are available within a site’s infrastructure already, to leverage different technologies or remote support teams. Additionally, consider what support and training will be needed to enable the sites to engage effectively in DCTs.
- Enhance the patient/physician relationship in a virtual world by providing options such that study teams, investigators, and patients have choices about how they can participate in a study. It’s important to recognize that one size does not fit all, so flexibility is crucial to allow for physician and patient choice in order for DCTs to be efficient and effective for both parties.
OSP: What’s ahead for Medable?
ML: We are very excited about the ongoing growth and adoption of decentralized technologies to support clinical trials around the world and the contributions that Medable are committed to delivering to support further patient accessibility and choices. As we continue to add further modules and functionality to our platform, we will enhance our capabilities to offer fully remote eConsent, web capabilities for sites and patients, and other features designed to deliver exceptional, seamless site and patient experiences.