In the 10 weeks following the US’ declaration of a pandemic crisis, hospital ER visits declined for conditions like heart attacks and strokes. Simultaneously, based on clinical trials in the Medidata ecosystem, new subject enrollment declined 30%. But also in that time period, ER visits related to uncontrolled high blood sugar saw less of a decline. Patients continued to seek care. Why?
One reason, says Ari Feldman, Medidata’s Vice President of Global Compliance & Strategy, may be technology.
Patients that relied on approved, at-home technology such as a blood glucose monitor were able to monitor their health and be acutely aware of the conditions that potentially warranted a hospital visit. In the midst of a pandemic, data could drive decision-making, like seeking out an ER when truly necessary. Conversely, the absence of reliable information in other patient groups, drove actions that may have been costly, medically unnecessary and even increased the risk of COVID exposure.
What if all clinical trials were similarly tech-enabled? How could the clinical trial landscape advance if more researchers had the ability to work remotely with patients and their data? Medidata sees the COVID crisis as revealing several opportunities that are ripe for data-powered progress.
Early in the pandemic, the company launched myMedidata, a tool for patients to participate in clinical research towards new COVID vaccines and treatments. The platform enables electronic consent, health monitoring through wearables, outcome tracking and study recruitment, all without requiring site visits. “We need to do everything we can to help patients continue their care in existing clinical trials. We can’t allow the public health threat caused by COVID to create another set of threats for these patients,” said Glen de Vries, Medidata co-founder and co-CEO.
Sponsors, sites, CROs and their technology partners are adapting to the new normal of the COVID era. The approach to risk is changing. “I have seen firsthand a difference in risk tolerance – not just one company to another, but within companies themselves,” said Feldman. But has COVID caused enough of a stir, both within regulatory agencies and within the industry, to drive lasting change that reflects a tech-enabled world? According to Feldman, more work needs to be done. Though we have seen global regulatory agencies each respond with COVID guidance, they continue to be disparate in their approaches.
The implications of this regulatory heterogeneity are profound. A lack of acceptance of eConsent means that entire nations may be excluded from clinical research in times of a global health crisis, when a sponsor wants to implement a study that uses an eConsent approach. When an entire population is left out, there are negative impacts on diversity and evidence from a range of care settings, on the rate of enrollment and, ultimately, progress towards advancing scientific understanding.
With thousands of studies and hundreds of thousands of sites feeding data into Medidata’s platform, there is now real-time, granular insights into the status of trials, in ways that were never before possible. “Enrolling 30k subjects for a COVID vaccine trial, for example, enables real insights and decision making about where a trial should be run, what the true impacts are, and what are some of the regulatory solutions that may or may not work,” says Feldman.
This robust data ecosystem helps drive smarter, faster decisions. Yet as Feldman explains, there is still an industry perception that regulatory guidance requires further granularity. Medidata’s approach, however, has been to examine what makes sense, develop a framework to manage risk around things like consent, monitoring, drug supply, and implementing technology to lead and advance the conduct of clinical trials. “There are going to be certain unknowns but we have to take some calculated risks and power through.”
2020 has taught us that science and technology need to be embraced with a patient-centric focus. But as demonstrated by the vast discrepancies between countries on core regulatory issues like consent and monitoring, it’s clear that the industry has more work to do. Redrafting and harmonizing these frameworks can speed drug and vaccine development. “We’ve always been on this path but COVID is an accelerant. We can’t be afraid of our shadow.”
Ari Feldman is Medidata’s Vice President of Global Compliance & Strategy
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