Technology Innovation in Clinical Trials is Here to Stay
The staying power of technology after the pandemic
The clinical trials industry has historically been slow to adopt innovation, but 2020 was a catalyst for transformation. Spurred on by the need for business continuity during the pandemic, sites and sponsors worldwide were highly motivated to reconsider business as usual, and many have adopted an array of technological innovations to enable trials.
“2020 was an inflection point for the industry. As remote monitoring became the norm, sponsors and sites embraced eSource, eRegulatory, eConsent, telemedicine and a host of new technologies. What was once novel is now mainstream,” says Raymond Nomizu, J.D., CEO and co-founder of Clinical Research IO (CRIO). “Several sponsors and CROs are now exploring systems like CRIO as a tool to incorporate on their trials.”
Is it worth it?
A primary concern with technology adoption is cost. But sites should consider the cost as an investment. One notable example is eSource. While eSource has been around for the last 10 years, it didn’t gain extensive adoption until the pandemic made it essential. It’s fair to say that eSource has already demonstrated its Return on Investment (ROI). In fact, many sites are already seeing the kinds of financial ROI that is critical for permanent incorporation. It appears that many of the innovations adopted during the pandemic are here to stay. Remote monitoring, telemedicine and the increased need to pivot to a decentralized trial approach have proven their worth. Sponsors and sites worldwide enabled trials during the crisis thanks, in large part, to the technological innovations at hand. Wearable devices, home nursing networks, and delivery of clinical and drug supplies to a patient’s home, all once pilot programs, have all gained traction in clinical trials as the new normal.
An increasing number of CROs and sponsors are taking these approaches under consideration. Solutions such as eSource, eReg and eConsent, all subject to FDA 21 CFR Part 11 requirements, have been used in hundreds of trials, a track record which should address any anxiety around noncompliance. More importantly, these software solutions actually help compliance because they reduce, if not eliminate, common errors, deviations and promote data integrity. Take, for example, the results of a CRA site survey showing that monitors favored CRIO’s remote monitoring software over paper to promote data integrity, compliance and rigorous QC by 3:1 margins.
Leading with vision
Site leadership and vision are critical to elevating site performance. Technological adoption has been shown to be higher amongst sites who take ownership in those decisions and choose their own tech solutions. Sites who understand the value that technology brings are naturally invested in successful adoption. A system that delivers faster startup times, better data and an easy user experience is invaluable to site operations.
From vision to action
MACRO Trials is a Site Optimization Organization (SOO) dedicated to providing the institutional infrastructure to perform the highest quality clinical trials across all specialties and private settings. MACRO is already reaping the benefits of technology. “We employ technology in a variety of ways at MACRO. For example, our recent partnership with MARTTI (My Accessible Real-Time Trusted Interpreter), a Language Access Network, facilitates real-time, on-demand access to translations in virtually every language. If we think about reaching underserved communities, technology, like MARTTI, is absolutely critical for simplifying consent,” explains Perez. “We also take into consideration that not all patients will make it to the trial site location for every visit. That’s where software like CRIO fits into the equation,” continues Perez. “Our ability to use CRIO to collect and streamline data anywhere, at any time, while integrating technology like MARTTI and telehealth, ultimately supports better experiences for patients and physicians alike.” The promise of technology has had a major impact on almost every facet of life. It’s no surprise that it’s also increasing patient participation, saving a considerable amount of time for clinical researchers, and making their jobs a little easier.
Shaping the future
Even with all that technology has contributed to clinical trials over the last year, there are still many more advancements and innovations yet to come. A recent survey by Florence Healthcare predicts increased collaboration between sites and sponsors in solving challenges by 2023, with 90% of sponsors and 62% of sites believing patient source data collection will be mostly automated by that year. Additionally, 80% of sponsors and sites expect consent, study startup, recruitment and monitoring will mostly be accomplished with technology by 2023.
“The true power of clinical research technology is still under-developed,” says Nomizu. “As the systems mature, and begin integrating with each other, tremendous synergies for sponsors, CRO’s, research sites and patients will present themselves. Through technology, we can actually bend the cost curve on the increasing price of pharmaceuticals.”