As current studies resume and new studies are approved, IRBs and researchers should keep basic safety and regulatory practices in mind, according to experts on the front lines of human research protection and clinical trials.
Research organizations have been adaptable, resilient, and trustworthy in the face of new challenges this year, said Bernadette D’Souza, MD, scientific advisor with Evolution Research Group (ERG) in Seattle. D’Souza spoke at a WIRB-Copernicus Group (WCG) web conference on April 15.
D’Souza noted these chief challenges for ERG and other research organizations during the COVID-19 crisis:
- Complying with quarantine and stay-at-home orders, which have caused disruptions in supply chains and a fear of the unknown;
- Ensuring staff and research participant safety;
- Developing best practices in uncertain times;
- Coping with study design changes.
“We call our subjects the day before. If they have any respiratory symptoms or illness, we ask them to stay home,” D’Souza said. “The same goes for our staff — if you’re sick, stay home. We have gatekeepers who screen all patients and visitors.”
Screening questions include asking participants about their health and checking their temperature and oxygen levels.
“We’ve continuously stressed to staff the importance of documentation,” D’Souza explained. “Our management team is very active and working long hours.”
Research organizations will still be challenged in keeping their studies moving forward during the crisis, particularly as social distancing and mobility affect research, noted Mark G. A. Opler, PhD, MPH, chief research officer with MedAvante-ProPhase. Opler also spoke at the April 15 web conference.
Assess Each New Trial Aspect
Research organizations should assess each new aspect of conducting clinical trials during the COVID-19 pandemic and recovery period, Opler said. He recommended these questions:
• If study participants or staff cannot go to the site, how does the research organization continue to evaluate safety and efficacy?
• Which clinical endpoints are accessible through remote methods?
• What is the right modality to ensure adequate data collection?
• How can organizations establish methodology and manualize procedures for remote use?
“These are challenging decisions because it’s not just about what the best method would be in the perfect universe,” Opler explained. “What is feasible and practical?”
For instance, it might be desirable to use high-definition, high-bandwidth videoconferencing capabilities. But this may not be realistic for participants at home.
“There is a need for guidance and structure and to create as much certainty as we can in an uncertain time,” Opler says. “Part of our responsibility in doing that is to make sure that when investigators connect with participants remotely, they can have every path.”
Another challenge is how participants perceive remote study visits. Logistical problems or distractions may occur, D’Souza noted.
“We ran into some problems where they’d say, ‘You can call me and I’ll be home,’ but the call comes in when they’re cooking dinner and they think they can handle the call,” she explained. “Often times, we have patients who gave us the wrong number, so this means we had some tight screening windows. If we couldn’t finish screening, then we would lose these patients as potential subjects.”
Experiment with Remote Visits
As IRBs and research organizations navigate uncertainty during the pandemic, they are serving as experiments in discovering what works well with remote visits.
“Before the pandemic, there were not a lot of people pushing the envelope or trying new things on a consistent or regular basis,” says David Borasky, MPH, CIP, vice president of IRB compliance with WCG in Princeton, NJ. “There might have been a component of someone doing something different, but it was more of an outlier and not a consistent thing.”
The pandemic’s role in pushing remote visits and strategies has helped the research community gain confidence in alternatives to in-person study visits. For example, researchers can use an interface that observes patients while they are at home, taking their medication, D’Souza explained.
When investigators compared data between pre-COVID-19 compliance rates and six weeks of post-COVID-19 rates, they found an initial dip in compliance that reverted to the regular range, D’Souza said. If more studies show positive outcomes with remote visits and use of investigational products, this could lead to post-pandemic study designs that include remote visits.
Another change involves study monitors. Due to travel limitations, study monitors have not visited most study sites. Instead, they engaged in remote monitoring, D’Souza said.
Focus on the Next Phase
During the next phase, research organizations should focus on these key points:
- Reassure and retain staff;
- Become more involved in decisions about study design and study execution;
- Recognize the increased financial and time burdens — even when there are fewer study visits.
“We want to express our desire to be strong partners in the research ecosystem as it exists,” D’Souza added.
As current studies resume and new studies are approved, IRBs and researchers should keep basic safety and regulatory practices in mind, according to experts on the front lines of human research protection and clinical trials.
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