Navigating Clinical Research in a Pandemic

St. Jude leaders work to balance safety and access to therapeutic clinical trials.

By Mary Powers

Cancer doesn’t stop for a pandemic; neither does sickle cell disease, hemophilia or the other life-threatening disorders at the heart of the St. Jude Children’s Research Hospital mission.

Elizabeth Fox, MD, hasn’t stopped. Neither have the 130-plus members of her Clinical Trials Administration team, or hundreds of other St. Jude faculty and staff who are part of clinical research at St. Jude.

“We are making adjustments that keep our patients safe but that also allow them to enroll in therapeutic clinical trials,” says Fox, senior vice president of Clinical Trials Research. That means continually assessing the COVID-19 risks to patients, families and others as well as the possible benefits of clinical research.

Clinical research is a cornerstone of St. Jude. Although COVID-19 has meant adjusting when, where and how clinical research is conducted, patients are still joining therapeutic clinical trials for acute lymphoblastic leukemia, brain tumors, immune disorders and other diseases.

Planning also continues for future clinical trials. Several therapeutic studies are on track to open in the coming weeks.

Three women at a table

(Clockwise from front) Tangie Thomas, vice president of Clinical Trials Operations; Elizabeth Fox, MD, senior vice president of Clinical Trials Research; and Dee Roe, vice president of Clinical Research Regulatory and Quality Management, have worked with colleagues throughout the institution to manage clinical research during the pandemic.

Adapting

But the COVID-19 pandemic has brought change.

 On-campus patient visits have been reduced. Visits related to surveillance, observational and other non-interventional clinical studies have been postponed. Enrollment in the hospital’s long-term follow-up studies, like St. Jude LIFE, are also postponed.

More clinical research, including research-related scans or laboratory tests, is occurring closer to patients’ homes. Patients are receiving care through St. Jude affiliate clinics or other facilities to reduce travel. Pandemic-related regulatory changes mean more chemotherapy and other drugs can now be shipped directly to patient families.

“We work closely with the principal investigators, the families and referring physicians to weigh the risks and benefits on a case-by-case basis of how best to proceed,” Fox says. “Our goal is always to continue to give patients the best care as safely as possible.”

Creating

Fox joined St. Jude in January as COVID-19 emerged as a global health emergency. She credits Dee Roe, vice president of clinical research regulatory and quality management; Tangie Thomas, vice president of clinical operations; and their colleagues with making the adjustments necessary to protect patients and maintain their access to therapies that might not otherwise be available.

Fox says she was drawn to St. Jude because clinical research is central to the mission.

 The crisis has given her a rapid introduction to the institution in extraordinary circumstances.

“Watching the St. Jude leadership and community come together and collaborate in the fight against COVID-19 has been inspiring,” she says. “That has provided great insight—challenging all of us to think creatively and work in groups that we might not otherwise have worked in to solve problems and then do it all again the next day.”

 
 
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