Disruption and innovation are key to driving needed improvements in the clinical trial ecosystem. Sparks of inspiration are an essential step in this process. Yet, as journalist and author Derek Thompson wrote recently in The Atlantic, invention alone cannot change the world. “Progress is as much about implementation as it is about invention,” with a series of breakthroughs being required to achieve progress, according to Thompson. Perseverance is required to transform clinical trials to advance drug development for the benefit of patients.
Mohammed Ali of Medable: “Reapplying learnings to spark change and achieve scalability”
“The COVID-19 pandemic provided new impetus for creativity in clinical research, following several decades with little major disruption,” says Mohammed Ali, Chief Domain Expert at Medable. “Now we need to persevere to build on this momentum and move forward, applying pandemic learnings to create sustainable approaches.”
“The technologies required for decentralized clinical trials (DCTs) existed before the pandemic, but there was little incentive to apply these at scale,” says Ali. “Everything changed with COVID, with urgent pressure to make DCTs work across portfolios. The definition of a site also altered, with novel models of delivery being explored. These might not fit the historical mold, but are an essential component of delivering high-quality research to make new and improved drugs available to patients worldwide.”
“Now we’re stepping back to reassess how to scale all these processes and capabilities, reapplying learnings to spark change and achieve scalability,” notes Ali. “This will require a push from all stakeholders—with sites and investigators playing an important role.”
John Campbell of Walgreens: Using retail stores to simplify and deliver studies
“At Walgreens, we are taking an innovative approach to help address major public health issues and drive better health outcomes for our communities,” says John Campbell, the company’s Head of Decentralized Clinical Trials. “Our retail pharmacies are a great asset here—with 78% of the U.S. population living within five miles of a Walgreens store. Making trial-related services available at these stores can make trials more equitable and accessible, and less burdensome.”
“At the same time, there is extreme fragmentation within the clinical trials sector, with a range of legacy systems and point solutions for specific problems at sites,” notes Campbell. “We have an opportunity to simplify trial operations and deliver studies that lower site and patient burden. We are making great progress with models and tools that will support efficient trials in the coming five to 20 years. These will help address common problems across the industry, including resourcing, patient access, and capacity constraints.”
“As well as bringing trials closer to patients and limiting barriers to participation, we are finding ways to improve the efficiency of study operations, increasing quality and reducing timelines and costs to make available new drugs for the patients who need them,” states Campbell. “All Walgreens trials operations are fully tech-enabled—including eConsent, eSource, and remote monitoring with real-time visibility into data quality and integrity. Enabled by these technologies, our hybrid clinical team can deploy resources that ensure that access and quality go hand-in-hand.”
Sparks, Signals, and Success: Bringing Dedication to Disruption
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Joy Bhosai of Pluto: Working to discover and close potential gaps in care
“In one example of a spark of innovation, Pluto Health is working with community health centers and retail pharmacies, to engage with patients along their health journey,” explains Joy Bhosai, MD, MPH, Founder and CEO of Pluto Health. “Our role is to support patient care, no matter where life takes them. From rapidly coordinating their care and health information—such as insurance, medical, and social information—we focus on understanding and delivering what they need to stay healthy. We work toward getting patients in line with clinical care guidelines and understand social drivers so we can close gaps in care.”
“The goal is to make sure that every patient receives the best possible care, including access to preventive health services, screenings, vaccinations, and clinical research as a care option,” adds Bhosai. “This enables us to engage longitudinally with individuals in a meaningful way via community-based approaches, helping engage diverse patients at the point of care by being integrated along the care pathway. This will form the foundation for a ‘bottom-up’ approach to achieving health equity.”
Scott Kollins of Akili: Gathering data to serve as a clinical feedback loop
“Innovation is central to our business model at Akili, which makes the only Food and Drug Administration-approved digital therapeutic products to treat children with ADHD,” says Scott Kollins, PhD, Chief Medical Officer at Akili Interactive. “Designing and executing prospective Phase III registration trials for a digital therapeutic had never been done before our studies.”
“Now that our product on the market, we are innovating to integrate delivery of a digital intervention with data collection,” adds Kollins. “Digital products are uniquely suited to this approach. For example, we invite every child and their caregiver who receive a prescription for our product to join a real-world registry. We are gathering data on a range of outcomes that can be useful not just to inform the development of our product, but also to serve as a clinical feedback loop to patients, their caregivers, and ultimately their healthcare providers.”
Author: Jill Dawson
