Tips for Reopening or Closing Research Studies
The 2020 landscape for clinical trials looks different than it did five or 10 years ago. Even before the worldwide disruption in research from the COVID-19 pandemic, there were systemic shifts that have squeezed trials in ways that add pressure to investigators and IRBs.
For instance, there has been a 70% increase in procedures required in Phase III trials, and an 86% increase in endpoints in Phase II trials, said Nicholas Slack, MBE, executive vice president and chief commercial officer at WIRB-Copernicus Group (WCG), speaking of internal data. Slack spoke at a Sept. 9 WCG webinar.
“Over the past 10 years, trials have become more complex and burdensome on sites,” Slack said. “More people and more technology are required to conduct clinical trials than was needed in the previous 10-year period.”
Along with the COVID-19 pandemic is the healthcare financial recession that was not present during the last major recession, he noted. “In 2008 and 2009, healthcare workers largely were not laid off,” Slack said. “That’s not the case in 2020 when 1.4 million healthcare workers have been furloughed or laid off. We’re facing a very different situation than we previously experienced.” (More information is available at: https://www.bls.gov/news.release/archives/empsit_05082020.htm.)
As the pandemic continues and research organizations are preparing to reopen trials, there is a looming crunch because more trial volume is on the horizon.
“Do we have a perfect storm of mounting financial pressures, staff shortages, and physicians exiting trials while sponsor trial volume is increasing?” Slack asked. “Trial delays have been increasing over time, and they could get worse.”
One risk is IRBs and research organizations will be inundated with study protocols when everything is reopened. They will need to prepare for reopening all operations and all studies. There are many steps they should take before making this decision.
Discuss Successes and Challenges
The first step is to meet with IRB and human research protection program (HRPP) leaders to discuss what went well during the pandemic and the closing of in-person operations, as well as what needs improvement, said Linda Coleman, JD, CIP, CHC, director of the HRPP at Yale University. Coleman spoke about IRBs and the pandemic at a PRIM&R virtual conference, titled, “Research Ethics and COVID-19: Lessons Learned and Future Considerations,” held Aug. 18.
Working toward a next phase of the pandemic plan is part of disaster and continuity planning. “I would encourage sites to think about what is going to work for them,” said Allecia A. Harley, MPH, CRA, chief executive officer and chief strategy officer of Lake Shore Strategy in Chicago. Harley also spoke at the Aug. 18 PRIM&R virtual conference. “It’s important to think through what works for us and how we can use the things that are working and expand them. A lot of challenges are not specific to the IRB space; it’s a general issue that everybody is dealing with.”
Coleman said decisions to reopen a particular study also involve these factors:
- Is the study in a hospital or standalone clinic?
- Is the study on campus or off campus?
- Is the study international?
- How is COVID-19 testing performed?
- Is the study therapeutic or non-therapeutic?
- What is the safety plan?
- Are temperature checks performed before entering the study site?
“It’s very complex and complicated because one size does not fit all,” Coleman explained. “We are saying, ‘If you are a researcher doing research with human subjects, you have to ask for permission to reopen your research if your study was put on pause.’” Sites must ensure the safety plan is appropriate before investigators can reopen the study.
As the organization prepares for a second surge, the groups that evaluate the pandemic and safety will decide whether the phase needs to be reduced and more studies put on pause.
“The [COVID-19] numbers are fine right now, but that could change at any time — next week, or a month from now,” Coleman said. “Researchers are aware they may have to ramp down again.”
The Yale HRPP is reviewing new studies as people continue to submit research, but they will need both IRB approval and institutional approval to begin work. “We’ve had a lot of studies that the university has reviewed related to COVID-19. Some studies were changed to include COVID-19 in part of it,” Coleman said.
The IRB did a good job of ramping down in March, and is ready to act again, if needed. “We’re providing more flexibility in terms of making a modification to the study,” Coleman explained. “Studies have used telemedicine and virtual communication with research participants.”
The IRB gives investigators guidance from the Food and Drug Administration about how to use a remote lab and arrange for a third party to make home visits to participants. There also is information on how to safely ship investigational products during the pandemic, and how to talk with sponsors about what needs to be done.
“Regulators provided enough guidance, and we were able to do the ramp down process quickly. We could do the same thing again,” Coleman said. “It might even go more smoothly.”
Pivoting back and forth between in-person IRB work is easier for research organizations since they already went through the abrupt change to online work at the beginning of the pandemic.
“You don’t have to spend a lot of money to make that pivot and to be prepared for remote work, or know how to manage your IRB during this time,” Harley said. “There are low-cost things you can do to still remain relevant, get your work done, and contribute in a meaningful way.”
Be Creative
IRBs have become creative in keeping staff safe while continuing daily operations and activities. For example, some IRBs have met in socially distanced outdoor settings.
“I’ve seen people be creative and take their IRB meetings outside or on a rooftop deck,” Harley said. “Sometimes, campus centers have an indoors garden, a solarium that is under glass and enclosed, but really is a park under glass. They can meet safely there.”
For some staff meetings, IRBs have occasionally given staff a break and used a fun app like House Party that allows people to put on a virtual detective mask or clown hat. “They’re being creative with where they meet and how they meet,” Harley added.
When research studies need participants who are recruited remotely to sign informed consent and regulatory documents, some IRBs in smaller cities have approved delivering the documents to participants’ homes via a staff member. Then, the staff member picks up the signed documents and scans them at the office, Harley said.
“For some organizations, DocuSign is outside of their budget, so they’ll print out the documents and drop them off in people’s mailboxes,” she explained.
That is impossible to do in a city the size of Chicago, but might be plausible in a town the size of Peoria, IL, she added.
IRBs also have adjusted by ensuring their information technology support provides email options that are encrypted, making it safer to share private information and large files. They have offered training to IRB members to help them connect to Zoom meetings and make other electronic changes.
The 2020 landscape for clinical trials looks different than it did five or 10 years ago. Even before the worldwide disruption in research from the COVID-19 pandemic, there were systemic shifts that have squeezed trials in ways that add pressure to investigators and IRBs.
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