‘Hybrid’ Trials Will Be Post-Pandemic Norm
By Deborah Borfitz
September 30, 2020 | For Medable, a leading advocate of decentralized clinical trials (DCTs), COVID-19 attracted surprising if welcome attention to the idea of making studies more patient-centric. The pandemic helped grow company revenues 400% in the first half of 2020 and, in the estimation of CEO and co-founder Dr. Michelle Longmire (a Stanford-trained physician), accelerated DCT adoption by five years.
While Medable’s mission is to cut clinical trial timelines in half, amplifying the voice of the patient has long been its rallying cry. With a physician at the helm, patient-centricity is part of the organizational DNA. Even Rasmus Hogreffe, newly appointed vice president of DCT innovation, waxes philosophical about making trials less taxing and inconvenient for participants. “The most precious thing we have here in life is time,” he says.
Pharmaceutical companies have traditionally been more than happy to stick to what they know is working, says Hogreffe, who previously worked as head of virtual clinical trials for Denmark-based LEO Pharma. This has contributed to the illusion that patients are afraid to use technology—or current technology is inadequate for the job—which an insidious virus has proven to be untrue.
The role of technology in clinical research as well as routine patient care has been staggeringly underestimated, as evidenced by the now months-long telemedicine revolution. Telemedicine is one of the foundational elements in the decentralizing of trials and the best way to move in-flight studies forward during a prolonged public health emergency, says Alison Holland, head of decentralized trials at Medable.
The pivot to a more decentralized format has been witnessed across therapeutic areas—including inflammatory diseases (e.g., rheumatoid arthritis), dermatology (e.g., psoriasis), rare disorders (e.g., hemophilia), oncology, and post-surgical recovery, she says. The need to connect remotely, including to re-consent patients who had signed up for the full bricks-and-mortar experience, has been the chief pain point.
Few companies will be going 100% remote for all of their clinical trials post-pandemic, but almost all of them want to move to some sort of hybrid model to streamline the operation of trials, improve the study participation experience and support sponsors’ diversity and inclusion efforts, says Hogreffe. Global trials being conducted in different countries and cultures need options regarding what gets decentralized, in part because regulatory environments are not the same the world over.
In a recent survey of healthcare experts by GlobalData, 67% of survey participants indicated that they plan to use decentralized clinical trials in the future. The shift was already planned, but COVID-19 sped up the timeline to the next one to two years—the primary reason being greater accrual of patients.
The shift toward decentralization has already begun, with protocols more often designed from the get-go to give participants the option of staying at home for many of their required study visits rather than traveling to a trial site, says Holland. Additionally, more real-time vital sign monitoring (e.g., blood pressure and body temperature) is being done via integrated, wearable health devices.
On a number of occasions, Medable has assisted in the digital recruitment of participants into studies, Holland says. A typical example is where patients eConsent to a trial and, if they meet the pre-screening criteria, are sent a home test collection kit. Cheek swab samples then get delivered by courier to a commercial laboratory for genetic testing to establish eligibility. “That’s a very workable solution, particularly in the U.S.,” she adds. It also speeds up the recruitment process considerably—9,000 patients in one year for one recent study, twice as fast as the sponsor had anticipated.
Medable is well positioned to support the industry-wide shift toward DCTs both because it has eight years of experience in the business and multiple new partners to help it deliver decentralized process capabilities à la carte through a single, seamless workflow, says Holland. One pivotal partnership is with contract research organization PPD, with whom Medable recently deployed its TeleVisit mobile application so patients can connect virtually with site coordinators, investigators or other care professionals from anywhere in the world to remove the burden, cost and COVID-related vulnerabilities of travel for on-site clinical visits.
The TeleVisit application, developed in response to the global COVID-19 pandemic, provides the workflow so trial sponsors can use the core capabilities and modular features of Medable’s digital platform, explains Holland. The app provides real-time video capabilities on a single platform that is 21 CFR, Part 11-compliant. There’s no “residual indicators” of study participation remaining on patients’ cell phones or internet-connected devices and metadata from the study gets time-stamped.
Most recently, Medable launched TeleConsent to enable fully remote informed patient consent and re-consent for clinical trials. Unlike traditional eConsent products that require both patient and investigator to be physically present together in the clinic, Medable TeleConsent allows patients, doctors, nurses, and clinical trial staff all to connect and sign remotely from any location.
Medable TeleConsent solves one of the most complex aspects of clinical trials for sites and sponsors, and transforms the initial experience for patients, says Holland. By eliminating the need for multiple round-trip visits to clinical sites, TeleConsent improves patients’ access to studies, connecting them directly with trial investigators and site teams from their home location. For trial sponsors, this can result in faster enrollment, greater participant diversity and increased study retention.
Ecosystem of Partners
For Medable, 2020 has been a newsworthy as well as noteworthy year. The company received investments from PPD as well as GSR Ventures, an early-stage healthcare and artificial intelligence (AI) investor. It also began working with Datavant on the ACCESS initiative—short for American COVID-19 Collaborative Enabling Seamless Science—to connect health researchers and clinical trial teams with home-bound individuals in the U.S. It subsequently announced plans to integrate Datavant’s technology into Medable’s decentralized trials platform.
This followed a global alliance with U.K.-based MRN, whose home clinical trial specialists have allowed study participants to connect virtually with investigators and study coordinators from anywhere in the world via Medable’s Trial-Fit Telemedicine app, and a partnership with AliveCor to enable in-home, AI-based ECGs (KardiaMobile 6L) as part of Medable’s platform. Back in February, Medable launched a Patient Advisory Council (PAC) to help inform efforts to improve patient access, experience, and outcomes in clinical trials, as well as joined the Global Genes RARE Corporate Alliance.
Moving forward, Medable will continue to configure its apps and platform features to accommodate the specific workflows required by other types of studies, says Holland. “Different studies need different capabilities and Medable’s technology flexibility means we can meet the unique needs of each study and enable the flow of data consistently between [any] ecosystem of partners.”
Independent patient advocates on the PAC, meanwhile, will be reviewing design features of Medable’s technology and proposed study workflows for opportunities to relieve participation burdens and, as Rasmus puts it, “minimize the gap between theory and process.” Incorporating the patient perspective in this way has accelerated patient recruitment and resulted in “extremely high” patient satisfaction for recent studies.
The 24/7 collection of real-world data is expected to accelerate the speed at which personalized medicines get approved by regulatory authorities for marketing, he adds. Adhering to international Good Clinical Practice guidelines, critical to the safety of human subjects in research, is a “top priority.”
Digital data can be collected in real time and enriched with contextual data—for example, the geo-location of patients when their asthma symptoms are exacerbated—to draw more accurate and objective conclusions, notes Holland. The application of AI and machine learning techniques will facilitate more rapid knowledge acquisition, with potentially huge impact on the design of healthcare and the detection of safety signals for patients of the future.
The synergy between the twin adoption of DCTs and AI will tremendously benefit clinical trial design, patient recruitment and evidence generation, Holland adds. Machine learning has in fact been deployed to predict future COVID-19 outbreaks, optimizing the feasibility process of one sponsor while ensuring the safety of participants and avoiding delays. AI methods might also be applied to electronic health records to forecast regions where COVID-19 patients are more apt to be in the clinical state required of an interventional study, or to aid in the development of digital biomarkers by separating signals from noise in data streams from wearable devices.