The oncology team at Johnson & Johnson’s Janssen unit had to think fast to support the thousands of at-risk cancer patients in the healthcare giant’s trials as COVID-19 spread. They ended up establishing a sort of a la carte flexibility menu for clinical trial sites—and it’s going to become a permanent offering.
“The patients with cancer in our studies were very vulnerable and high risk for COVID, not only for COVID infection, but very bad complications from COVID,” said Craig Tendler, M.D., vice president of clinical development and global medical affairs, oncology.
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So, despite being a part of the world’s largest healthcare company, Janssen’s oncology crew went “almost patient by patient” to offer flexibility and ensure they could participate comfortably.
“It was pretty amazing in terms of what sites did to continue to keep patients with cancer at the forefront and really continuing on this long mission of trying to … develop transformational therapies,” Tendler said.
Janssen also saw some of its clinicians jumping to fill gaps at hospitals as their peers left their normal working duties to help in COVID clinics.
“Early on in some major academic centers, there was a need for some of the oncology staff to take care of the other patients in the hospital and to really pitch in where needed,” Tendler said.
Janssen employed home health nursing, mailed medications, travel assistance programs, telemedicine and decentralized trials. Instead of making patients come in for lab tests, they sent nursing staff to collect specimens or arranged for patients to visit a local lab to avoid the usual clinical research center conducting the trial.
The study sites kept up a “constant dialogue” with Janssen’s oncology staff to review each patient and anticipate the next study visits so plans could be made.
“There were some trials where enrollment was reduced, mainly because the sites were understandably and appropriately busy,” Tendler said. Janssen prioritized the patients who were already enrolled to ensure those studies could keep going.
Turnkey tools
Janssen’s strategy of “maximal flexibility, maximal support” allowed trials to continue with minimal disruption, Tendler said.
Some patients did miss their check-ins, and missing data had to be documented. Those updates were done based on guidance and discussions from the FDA, and Janssen then incorporated the modified information into revised statistical analysis plans.
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“It's very helpful to have the guidance from the FDA as to how to take into account patients who may have missed study visits, tumor evaluations,” Tendler said.
Disruption for Janssen began in April, but trials were able to begin enrolling again at a normal pace around September, Tendler said.
Now that the Janssen team has bulked up on technology to support virtual trials, telemedicine and the other measures it took to get through the pandemic, there’s no going back to business as usual.
“We now have that very streamlined and built in to our program, so the whole idea is that none of these are new functionalities anymore,” Tendler said, adding that Janssen wants to make all of these new tools “turnkey” for any study site that needs them. “These are all the regular way of doing things, and study sites can sort of opt in to any of these functions or programs.”
“If they would like to utilize home health nursing, we have that. If they want a travel assistance program, we work closely with a vendor that provides that service for study patients,” Tendler said.
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The oncology team also learned to be flexible during the pandemic: If oral medications can be delivered, send them out instead of making a patient come in for administration.
Tendler does not see the new protocols providing cost savings, but they do help tip Janssen’s clinical trials program toward a more patient-centric focus. The new tools support patients, “so it's less of a burden for them to participate in a study,” he said.
“We don't want this to be just something that was done for COVID, and we pack it away when we get past the immediate complications of the pandemic,” Tendler said. “We do see many benefits of continuing to make our trials extremely flexible, less burdensome for patients—especially for the underserved minorities.”