“This is, indeed, like nothing I have ever experienced in 20 years of research,” says Laura Menck, CCRA, ACRP-PM, a clinical project manager in the U.S. for the Amsterdam-based health technology firm Philips, of the current international health crisis. “The only thing I can liken it to is right after 9/11.”
However, even in unpredictable times such as these, Menck and other clinical trial sponsors active in the field are guided by one overarching principle: “All decisions and communication should be based on how we ensure patient safety first,” she says.
There’s another important idea to have at top of mind, Menck notes. “This is new territory for everyone, and each [part of the country] or institution is handling it as best they can or in harmony with their” regulatory requirements, she says. “Approach site teams with compassion and understanding.”
Menck offers several other helpful tips for sponsors navigating these uncharted operational waters:
- Provide a unified and clear message to sites regarding procedure changes or study expectations—especially if they are working with the sponsor across multiple studies. Limit the number of e-mails if possible, as everyone is getting inundated.
- Timelines may have to be adjusted. Many institutions are completely halting study or other ancillary or elective activities until further notice. “This is going to impact study timelines, enrollments, study conduct metrics such as deviations, etc., and everyone just needs to accept that and have discussions based on solutions, proper decision making, and GCP/ICH-based decision-making,” Menck says.
- Determine if a remote visit (phone call) strategy is possible for study visits and then capture in-person assessments later, if possible. This goes for remote monitoring, as well. Site leaders will want to know if they are going to be accountable for deviations due to missed visits or testing; communicate the sponsor’s decision on this matter up front and clearly.
- If a central or local institutional review board is involved in a study—start having discussions with the board now about what can be done to document sponsor decisions and provide the best outcomes for patient safety and follow-up.
Finally, the coronavirus is a moving target in more ways than one. “The situation will be in flux for quite some time; what we know today may change by tomorrow,” Menck says. “However, our research community is in this together. We will stay committed to the needs of our research patients, and we can all be confident that our industry will be at the forefront of solutions for health crises like this in the future.”
Meantime, Devana Solutions, a technology provider for clinical research projects, told customers yesterday (March 17) it did not anticipate any interruption in services. “A significant number of our employees already work remotely, and we are fortunate in that our business allows us to easily transition to a fully remote workforce,” the company said in a statement.
Author: Michael Causey