How COVID-19 Is Catalyzing Technology Adoption in Clinical Trials
Medidata’s Anthony Costello, SVP, mHealth, participated in a panel at OCT USA 2020 focused on how COVID-19 has affected clinical trials. This blog post captures key insights from the conversation.
How have regulators adapted guidance for operational changes due to COVID-19?
The panelists agreed on the fundamental concern regarding regulation: Regulators want to see an audit trail they can understand. The new challenge with COVID-19 has been to demonstrate its impact on trial operations. FDA guidance, according to the panelists, helped sponsors determine how to track operational impacts from COVID-19. For example, many patients—especially elderly populations—expressed reluctance regarding in-person checkups, even in areas less impacted by COVID-19. Documenting those impacts has been an important part of the process for trials that continue to operate during the pandemic.
To overcome operational challenges, sponsors and CROs have, in many cases, turned to technology. The panelists emphasized the remarkable immediate response from regulatory agencies to help sponsors use technology in new ways, especially in decentralized trials. Some aspects of regulatory changes regarding new technologies were already underway before the pandemic. A panelist highlighted that about a month before the pandemic significantly impacted the US, the FDA invited clinical supply experts to talk about direct-to-patient logistics.
But the panelists noted that the life science industry is risk averse by nature—companies avoid new methods when they worry about regulators questioning how technology was used or how data was presented or collected. In general, the panelists agreed the FDA has been supportive, especially with technology, over the last several years by offering less prescriptive guidance. In response to COVID-19, the panelists characterized the FDA as even more willing and excited to provide guidance for companies to work with new and existing technology.
How has COVID-19 impacted attitudes toward technology in the industry?
Since many patients have been required to stay home due to COVID-19, companies that may have been reluctant to adopt new technology in the past are now finding these technologies necessary. While some companies have started using technology for single processes like eConsent, ePRO, and anything in between, other companies have taken trials fully virtual.
Going forward, the industry has the opportunity to closely examine cases where technology improves the patient experience with flexible, patient-centric options regardless of COVID-19. Many patient populations already faced significant obstacles to participation in clinical trials prior to the pandemic, and those inherent challenges for sick patients won’t disappear when the pandemic ends. Furthermore, budgets often can’t support fully on-site operations, leaving potential drugs stuck in pipelines because the cost of clinical development is so high.
As they discussed these challenges, the panelists asked: What do we do? What can we accomplish together? They noted hopeful and remarkable cases of companies starting new trials and understanding better ways to interact with patients during the pandemic. In some cases, the FDA works side-by-side with sponsors to get trials up and running rapidly and with confidence. One panelist marveled at the ongoing COVID-19 trials with 18 month timelines and tens of thousands of patients, something that would normally take 10–15 years of planning in normal conditions. The panelists all agreed that this is possible only because the technology already existed for processes to allow for flexibility of trials this size, and the cases prove the value of technology in clinical trials on an unprecedented scale.
What impact has COVID-19 had on decentralized drug development and remote monitoring?
One panelist asserted that the acute phase of COVID-19—regarding immediate impact on clinical trials and impacting hospital capacities—is slowing. Now the proactive phase arrives, where sponsors are planning ways to preemptively mitigate risk to studies, in many cases looking to providers for ways to execute these plans. Remote monitoring emerged as a central topic in the conversation. Sites, in the past, couldn’t allow remote monitoring in many cases because of outdated technology. But as sponsors have adapted operations in the wake of COVID-19, sites appreciate remote monitoring as a good option and see the value and opportunity.
Ultimately, COVID-19 operating conditions have proven the value of technology created long before the pandemic. While some technologies radically shift trial operations, others are simple to adopt but add significant value. A panelist offered the example of talking to patients at home in quarantine on the phone—in this case, it’s easy to add video to a phone call, or offer eConsent for patients to avoid bringing thousands of patients into a site.
The panelists remarked how COVID-19 “woke up” the industry—if you're not aware of the options when you're planning your study, your study has significant risks. The technology already exists, and COVID-19 operating conditions have catalyzed adoption. Some studies, a panelist noted, will never be able to be decentralized, like oncology indications involving infusions. But everyone agreed: Even if you don’t use modern technology, you need to know what it is and how to use it to be able to adapt.
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