MAINTAINING ONCOLOGY CLINICAL TRIAL INTEGRITY
DURING THE COVID-19 PANDEMIC
COVID-19 immediately affected the conduct of ongoing clinical trials but it equally changed the way they will be conducted in the future, said speakers at the CEO Roundtable on Cancer online conference April 24 on "Maintaining Oncology Clinical Trial Integrity during the Covid-19 Pandemic."
"Oncology trials represent an important subset of clinical trials," said Dr. Mace Rothenberg, panel moderator and Chief Medical Officer, Pfizer. "There is the serious and life-threatening nature of the disease; the fact that a clinical trial may represent the best or only option for some patients with few or no other therapeutic options; they require special expertise in administration, monitoring, and management of acute adverse events or hypersensitivity reactions; and the use of advanced technology processing samples that cannot be easily performed outside of trial sites."
There were three primary areas of discussion about trials amid the pandemic: managing patients in studies, managing data from studies, and interpreting trials with missing data and other challenges.
Speakers included clinical trial experts from industry, academia, and the US Food and Drug Administration who shared recent experiences. The audience was invited to pose questions and more than a dozen FDA staff attended the 90-minute panel to gather input and learn more about what's happening on the front lines of research.
Within the US there have been wide geographic disparities in severity of COVID-19 and response to the virus, which makes trial operations challenging. But many shared accounts of positive results with telemedicine that will become a standard trial feature going forward.
"If there is a silver lining, it is that we are running a grand experiment concerning decentralized trials," said Dr. Paul Kluetz, Deputy Director, Oncology Center of Excellence, FDA. "We have been interested in this for a long time, because they can show us efficiencies and can be quite patient friendly."
Other speakers expressed frustration that regulatory agencies around the world do not agree on what trial modifications are permitted.
"Most of our recommendations at the moment have been based on internally coordinating across centers and within FDA and less of a coordination externally with the other regulatory bodies," said Dr. Patricia Keegan, Associate Director for Policy, Oncology Center for Excellence, FDA. "That's why I was particularly interested in comments about differences across regulatory agencies that are posing particular problems."
Panelists agreed that some of the most pressing questions that remain include:
- How should missing trial data be handled? What statistical techniques should be used to address this?
- How do we assess the impact of geographic disparities because of the varying intensity and duration of the pandemic?
- How will we share information about tools and technologies that have been effective for remote monitoring and data collection?
- How should we view the so-called "period" effect related to the time before, during and after COVID?
- What should be site-level protocol deviations versus protocol amendments? Safety measures are being implemented without approval leading to compliance concerns.
- How do we always keep in mind the benefit to patients as well as their safety?
"We are in the middle of a grand experiment. What we don't know yet is the result of that experiment," Dr. Dave Reese, Executive Vice President, R&D, Amgen, said in summing up the conference. "What are the conclusions of the experiment? I believe it's incumbent on all of us to really ask fundamental deep questions of what do we change permanently? There are many things that we must learn from this experiment."
Most of the attendees represented pharma and biotech industries but government agencies, academia and others, including non-profits, also made up a substantial part of the audience.
Post-event surveys reflected that participants found the content important and they would likely attend a future virtual meeting hosted by the CEO Roundtable on Cancer. Discussion is ongoing about future topics for similar events.