Covid 19 Pandemic Brought Pluses to Participants in Remote Clinical Trials

By: Rivkah Lewin

When Covid 19 made its grand entrance in 2022, clinical trials were battered.  With universities closing and hospitals struggling to attend to hoards of ailing patients, numerous studies that required participants to visit in-person were relegated to the back burner or called off completely.  At Johns Hopkins University, for example, researchers postponed their investigation into how adults aged 65 to 80 metabolize tenofovir, a drug used to prevent and treat H.I.V.  

However, some physicians found ways to turn challenges into opportunities.  Unwilling to surrender their studies to Covid, they side-stepped the dangers of face-to-face visits by mailing meds to patients, conducting exams via video chat, and teaching patients to monitor their own vitals from the comforts of home.

This opened the eyes of doctors to the burdens they’d been placing on clinical-study participants for years. In fact, responding to underrepresentation of minority members in clinical trials, the FDA issued guidance to narrow the gap.  Researchers discovered that virtual, or remote, clinical trials—those designed not to require participants to travel to study locations—make it possible for more low-income patients and those who live in rural locations to participate, according to Dr. Hala Borno, an oncologist at the University of California, San Francisco.  

In short, the transition to virtual studies could offer state-of-the-art research opportunities to people who otherwise wouldn’t have the ability or financial resources to travel to take advantage of them.    

From the vantage point of researchers, virtual studies may also be cheaper and more efficient to conduct.  Investigator fees alone are significant, costing between 40% to 60% of a total clinical-trial budget, estimates Debora S. Araujo, CEO of ClinBiz.  Remote monitoring of patients can reduce trial costs by 25% to 30%, said Araujo.  It can also lower costs of patient travel and the amount of staff required to do on-site monitoring.

Dr. Ray Dorsey, a neurologist at the University of Rochester who performed remote research for years said that cutting back on in-person visits could make recruiting patients easier and reduce dropout rates, leading to quicker, cheaper clinical trials.  Enrollment in his clinical study to track people with a genetic predisposition to Parkinson’s, surged during the pandemic. 

Remote trials present their own challenges, though.  Researchers need to monitor participants’ health without in-person visits, but not all patients are comfortable with technology and some don’t have access to it.  What’s more, homes are not controlled environments; a grandchild or cat crawling on a patient while they’re monitored at home can affect results.  

Dr. Brennan Spiegel, a gastroenterologist and director of Health Services Research at the Cedars-Sinai Health System, found unpredictable and even comical results when monitoring patients at home.  Spiegel uses Fitbits—wearable technology—to track physical-fitness activities of participants remotely. When he saw measurements recording thousands of steps, he investigated and found that patients inadvertently sent their Fitbits through the washing machine.  Another patient put his Fitbit on a dog.  

 

As researchers iron out the kinks in remote studies, Dr. Deepak Bhatt, a cardiologist at Brigham and Women’s Hospital in Boston, noted a positive result of the pandemic:  “It takes a crisis to provoke change,” he said.

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Sources:

Debora S. Araujo:  Price Check: How to Cut Costs in Clinical Trials (anjusoftware.com)

Dr. Ray Dorsey, Dr. Hala Borno, Dr. Brennan Spiegel, Dr. Deepak Bhatt:  Clinical Trials Are Moving Out of the Lab and Into People’s Homes – The New York Times (nytimes.com)