Clinical Trial Risks

How to Manage Patient Fear Regarding Clinical Trial Risks

Clinical trials remain essential in order to understand the effects of medical developments on the conditions and patients they are intended to treat. Yet clinical trials remain out of reach for many patients.


For example, a 2019 study by Joseph M. Unger and fellow researchers found that only 8.1 percent of cancer patients enrolled in a clinical trial related to their condition. Barriers like the need for physical attendance and frequent visits made clinical trials difficult to attend even before the onset of COVID-19.

Now, in the face of the pandemic, clinical trials have become even less appealing to patients. Fears about receiving medical care in general, and about frequent face-to-face visits in particular, cause patients to shy away from medical care, especially when it is not deemed essential. To address these fears, as well as other effects from COVID-19, clinicians will need to take a long-term view.

COVID-19 and Changing Perceptions of Clinical Safety

“Some patients with true emergencies refused to go to the emergency room for fear they would be infected,” writes Tammy Chang, an assistant professor of family medicine at the University of Michigan Medical School.

During the initial wave of the pandemic, hospitals raced to keep up with the influx of COVID-19 patients, but the number of other cases that appeared in emergency rooms slowed to a trickle, says David Tashman, M.D., who runs the emergency room at the University of Southern California’s Verdugo Hills Hospital.

“We would normally see a hundred patients a day, and then, you know, overnight, we were down to 30 or 40,” says Tashman.

As patients avoided medical care out of fear, medical practitioners’ fears began to mount as well. In a May 2020 study published in the Pakistan Journal of Medical Sciences, Uzma Urooj and fellow researchers found that of 222 doctors surveyed, 79.7 percent feared they would bring COVID-19 home to infect family members.

Early fears experienced by practitioners, fueled by a host of unknowns, also changed the course of care for some patients. During the early stages of COVID-19, “I began to wonder whether this fear is driving some of the striking deviations away from standard care that we are seeing for COVID-19 patients,” writes E. Wesley Ely, co-director of the Critical Illness, Brain Dysfunction and Survivorship Center at Vanderbilt University.

Clinical Safety

Tools and Strategies for Encouraging Enrollment

When patients are willing to postpone even emergency care out of fear of contracting COVID-19, it’s more important than ever to communicate, educate and allay patient fears about participation in clinical trials.

Clinical Trial Flexibility and Patient Support

In an August 2020 article in JAMA Oncology, researchers Chadi Nabhan, Toni K. Choueiri, and Anthony R. Mato mention several changes to current US clinical trial procedures that have been made or that could be made to help reassure patients of the safety of participation while also taking steps to actually reduce the risk of infection.

For instance, they address the recent emphasis on telemedicine, which both the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services have also favored.

They also note that recent FDA guidance on clinical trials permits sample collection for laboratory testing to be done at labs local to the patient, rather than at the clinical trial’s centralized location. The authors encourage localized laboratory testing as a norm: “Because basic laboratory tests are standardized (eg, complete blood count, chemistry) and the pathology of a tissue biopsy or a bone marrow needs to be reviewed centrally, we see no reason why these routine and basic tests cannot be performed at the location most convenient to patients, provided no special expertise is needed.”

As COVID-19 lingers in the population, clinical trial organizers can gather resources to help patients participate without experiencing unnecessary stress or fears about their health.

Connecting Through Distance: Promoting In-Person Visits Without Risking Patient Health

Social distancing and other protective measures are reducing or attenuating contact between doctors and patients in many clinical settings. While virtual visits and similar tools can be valuable ways to monitor patients during clinical trials, they can also add to patients’ sense of frustration and loneliness.

“Zoom visits and telephone calls cannot substitute the therapeutic power of presence,” writes Liza Buchbinder, a hospitalist and cultural anthropologist at UCLA. For clinical trials, harnessing the benefits of in-person visits while allaying patients’ fears about COVID-19 will require clear communication and education for patients as well as safety measures designed to reduce transmission itself.

Clinical Trial Coordinators as Educators: A First Line for Patient Reassurance

The FDA released information for clinical trial participants in early April 2020. There, it recommended that participants speak directly to the trial coordinator for more information on patient safety during participation in the trial. The FDA also noted its interest in promoting telemedicine and other means to support patients while reducing the risk of in-person virus transmission.

COVID-19 has not changed the need for clinical trial sites and coordinators to communicate with and educate patients. Rather, the virus has added another dimension to this responsibility: The need to educate patients about the risk of virus transmission and how to participate in clinical trials without taking on unnecessarily high risk.

Patient Reassurance

COVID-19 and Clinical Trials in the Long Term

“The formidable barriers to designing, implementing, and completing clinical trials, especially in the midst of a pandemic, are clear,” write physicians Crystal M. North, Michael L. Dougan, and Chana A. Sacks in a July 15, 2020 article in The New England Journal of Medicine. At a time when clinical trials require resources in order to succeed, those same resources are being redirected to address the tide of COVID-19 infected patients, they note.

This resource redirection even affects clinical trials of medications and products intended to prevent or treat COVID-19, North, Dougan and Sacks write.

Increasing Risks for the Clinical Trial Candidate Pool

In June 2020, Mia Taylor, director of community and post-acute care services at The Queen’s Health Systems in Hawaii, noted that the hospital system had seen an increase in patients cancelling or postponing both preventative care appointments and treatment for ongoing chronic conditions like diabetes.

“We’re super worried about this because we just feel like it could be the next pandemic or tsunami, if you will, of people who have put aside some of these very important evaluations. As a result we feel like we may see this big uptick in complications associated with chronic disease,” says Taylor.

Chang puts it this way: “The COVID-19 pandemic is our current public health emergency, and it’s deadly serious. But I worry that the aftermath may be just as bad. We need to plan for it.”

The trend of avoiding in-person care is likely to continue. The third COVID-19 Black Book Market Research/Sage Growth Partners survey, conducted in late April 2020, found that while respondents’ overall anxiety about the virus had decreased, their unwillingness to go to the doctor’s office had actually increased.

“These fears are keeping people away from their doctors’ offices and hospitals as they delay and avoid care for chronic conditions, illnesses, and injuries because of concern about potential exposure to COVID-19,” the study states.

The COVID-19 pandemic is likely to continue for several months or perhaps years. The psychological effects, including fears about medical treatment, and the repercussions of delayed care may last even longer. By employing new methods for clinical trial performance and educating patients about the true risks they face and their options for mitigation, clinical trial coordinators can help ensure patient participation in clinical trials.

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