April 9, 2020

AP Perspective on Oncology Clinical Trial Management Challenges During COVID-19 Pandemic

By A. Kate MacDougall

As more and more clinical trials begin analyzing the novel SARS-CoV-2 virus and the efficacy and safety of potential treatment options, many of us are left wondering about how the virus will affect ongoing and future clinical trials for other diseases, especially cancer. Nataya Francis, ARNP, nurse practitioner in the Clinical Research Unit at Moffitt Cancer Center, is seeing the impact on the oncology clinical trials management process firsthand.

Role of Clinical Trial Coordinators
With increased numbers of advanced practitioners (APs) and other clinicians working from home, when possible, and patients staying at home, Francis says one of the biggest impacts on clinical trial management is not having the entire clinical trial staff and all the patients on site.

“When you have a [clinical trial] coordinator who’s not on site, whoever is on site now is covering for that coordinator,” she explained. “So you might have [to work with a substitute] coordinator who has the knowledge but not the in-depth knowledge per se compared to the [main] coordinator who’s been doing that trial for years.”

Telehealth Requirements
In terms of working with clinical trial patients during the pandemic, Francis noted that her team is beginning to utilize telehealth in whatever way they can. However, in clinical trial management, it’s not as easy as jumping on a virtual call. Telehealth appointments with clinical trial patients have to be approved by the trial’s sponsor and the Institutional Review Board, and virtual visits aren’t feasible during certain phases of a trial.

“[First, a virtual visit] has to be appropriate for the patient. Of course, for patients who are on active treatment, there’s no way to do telemedicine. It really takes having several boxes checked before you deem that this patient is able to do telemedicine,” Francis said. “Then, the final [question]: Is the patient willing to do a virtual visit?”

Drug Supply Considerations
Clinical trial staff may also be able to ship oral trial drugs to patients so they don’t have to leave their homes for treatment. However, much like employing telehealth visits, the shipping of oral investigational drugs for clinical trial participants also requires sponsor approval.

Looking to the days, weeks, and months ahead, Francis hopes that clinical trials don’t have to deal with drug shortages, which could severely impact the progress of the studies and place a delay on trial data being published and even new drug indications being approved.

“Because we have more people being affected, they have to stay home, staff is minimal, and you just have that ripple effect. Hopefully [it doesn’t get] to the point where we have a shortage of drugs…have to shut things down,” Francis said. “But health care is such an essential service, and we don't expect that.”

Despite all these changes to the clinical trials management process and the challenges they present, Francis said that she and her colleagues are continuing to put patients first and working to treat them in a safe manner, and patients are thankful that they can still receive their essential treatments.

“I know it’s a lot of change, but [we need] to rise to the occasion and keep providing, as we always do, the best care we can,” she said. “Encourage your patients, encourage yourself, keep pressing forward, and just keep doing what we do as APs.”

Read more from the APSHO Advance: Special COVID-19 Series