April 16, 2020

Communication and Collaboration: Keys to Clinical Trial Management Success During the COVID-19 Pandemic

By A. Kate MacDougall

Across the world, oncology/hematology clinical trials are being put on hold and others amended to reflect the current limitations on travel and access to study medications due to the global COVID-19 pandemic. Among all of the challenges this brings, Allyson Price, PA-C, physician assistant in the Leukemia Department at MD Anderson Cancer Center, says that she’s seeing positive changes as well, including increased cross-institutional collaboration and open communication.

Travel Restrictions
On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued guidance for the execution of clinical trials during the SARS-CoV-2 pandemic acknowledging that protocol amendments may need to be made and providing suggestions for navigating these challenges. One of the FDA recommendations was the assessment of alternatives to in-person patient visits, which Price explains has been the biggest hurdle to overcome so far.

“Due to travel restrictions, we’ve had to be really flexible in our [clinical trial] management to ensure safety and continue care,” Price said, referring to her patients on clinical trials who typically travel to her institution to receive treatment.

In an effort to overcome this obstacle, Price’s institution has increased collaboration and coordination of care with local oncologists, including the primary team, study PI, and research team, as well as patients. Local oncologists have been willing to schedule labs and other tests at local facilities, and, when possible, she and her team have been working to ensure that local oncologists have access to the study treatment or alternative therapy options so patients can be treated closer to home.

“I have to give kudos to all the people from the research team…who are doing all the behind-the-scenes work to continue [clinical trial] care and…to ensure that the safety of our patients is being met,” Price said. “They’ve been huge advocates in the continuation of this ongoing endeavor.”

Recruitment
Price also noted the pandemic’s impact on clinical trial recruitment, especially for phase I healthy volunteer recruitment and for those studies with enrollment that involves multiple follow-ups or lab tests. Forthcoming data from ongoing clinical trials may also be delayed. And although most trials will not be penalized for data delinquencies or protocol noncompliance during this time, based on the FDA guidance, they will still need to report and document deviations.

“Data efficacy [of ongoing trials] is going to be something that we’ll also have to look at very closely, especially for the patients who do test positive for COVID-19,” Price said. “That may skew and create this outside variable that we haven’t had to deal with before [in clinical trial management].”

Despite all of these changes and uncertainty, Price said that providers and patients are coming together and adapting to this new reality. She encouraged APs to continue staying up to date on all FDA and Centers for Medicare & Medicaid Services guidance, to prioritize communication with patients and each other, and focus on keeping patients safe.

“Right now, as APs, we can [tackle these challenges] by ensuring our patients’ confidence in their oncology team, through open communication and transparency, minimizing the stress that we can, and providing emotional support.”
  

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