COVID-Era Clinical Trial Protocols May Expand Access

The COVID-19 pandemic caused a major shift in the way that health care was delivered, and while some of these changes have already come and gone, certain pandemic-era practices have been recommended to continue when it comes to conducting cancer clinical trials.

“We started with things that could be improved or that were improved during the pandemic, because all of these adaptations and changes and decentralizing make the clinical trials focus on the patient, as opposed to focused on the clinical site,” said Dr. Antoni Ribas, professor of Medicine, Surgery, and Molecular and Medical Pharmacology at the UCLA said in an interview with CURE®.

Ribas, who was previously president of the American Association for Cancer Research (AACR), was one of the authors of an article published in Cancer Discovery that outlined the changes to clinical trials that should stay after the pandemic.

Adaptations include:

• Remote consenting and telemedicine, when possible
• Allowing patients to use laboratories and imaging centers closer to where they live
• The delivery of investigational drugs to the patient’s home or local clinic
• Administration of drugs at the patient’s home or local clinic
• Commercial attainment of study drugs previously approved in other settings

If followed, these changes can expand clinical trial access to people who otherwise may not have been able to participate – such as those who live in rural areas, far away from a major cancer center.

“I hope these changes stay because many of them were an improvement,” Ribas said. “But inertia seems to be to go back to the old ways.”

Patients involved in clinical trials should talk to their treatment team about remote consenting or having treatments and follow-ups take place locally, especially since those changes are within Food and Drug Administration (FDA) regulations.

“It turns out that the FDA has a whole bunch of existing regulations that allowing doing remote consent, allowing decentralized clinical trials. It’s just that we’re not taking advantage of that,” Ribas said. “I’m worried that if we don’t keep advocating for decentralized trials, we’re not going to get there.”

The article also listed ways to make trials more efficient and accessible, such as remote drug infusions and monitoring, increasing funding for clinical trials in underserved communities, expanding clinical trial eligibility, and reducing the collection of low-grade side effects and allowing minor protocol deviations.

“Part of treating patients with cancer is doing clinical trials because in many indications, the standard treatments are not optimal,” Ribas said. “So clinical research is the best option.”

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