Clinical Trials & COVID-19: Charting New Territory

There’s no corner of our healthcare system that the coronavirus has not penetrated. While swamped intensive care units and protective mask shortages dominate the headlines, the secondary and tertiary consequences of this contagious and potentially deadly virus are also coming to light. One such example is the effect of COVID-19 on clinical trials. For patients with advanced cancers that have not responded to previous treatments, clinical trials are often the last option. Interrupting those trials could not only potentially endanger the lives of their participants, but also could set back promising treatments that have demonstrated efficacy and are advancing toward approval.

Closing the Gap

Shortly before the World Health Organization announced that COVID-19 was a global pandemic, Randall Oyer, MD—medical director of the oncology program at Penn Medicine Lancaster General Hospital—was named ACCC President 2020-2021on March 6 during the ACCC 46th Annual Meeting & Cancer Center Business Summit. As all ACCC presidents do, Dr. Oyer selected a President’s Theme for his term in office. Dr. Oyer's theme is: “Community Oncology Can Close the Gap in Cancer Research.”

“Over the past year ACCC has heard from our members that there are gaps in community research,” said Dr. Oyer. Respondents to ACCC’s 2019 Trending Now in Cancer Care Survey identified their top three challenges to offering patients with cancer clinical trials as: 1) staff resources and training (53%), 2) program infrastructure (50%), and 3) lack of patient understanding of the clinical trials process (46%). Citing these survey findings, Dr. Oyer remarked: “We have a serious imbalance in our clinical trials work. Our patients are in the community, yet the trials are at academic medical centers. And I believe that ACCC is uniquely situated to close this gap.”

COVID-19 Fallout

By mid-March the rapidly spreading COVID-19 outbreak across the U.S. was re-shaping the clinical trials landscape, and Dr. Oyer’s presidential theme had taken on a more urgent dimension in relation to the ongoing operation of in-process trials.

In a recent interview with Targeted Oncology on the fallout of the coronavirus on clinical trials, Dr. Oyer said that although he personally does not know of any current trials that are on hold due to the ongoing pandemic, the opening of many new trials and patient enrollment in them have been put on hold. “At my organization,” Dr. Oyer said, referring to the Ann B. Barshinger Cancer Institute at Penn Medicine Lancaster Health, “we are going to suspend opening new clinical trials, and we are not going to enroll new participants in existing clinical trials unless there’s someone with an acute cancer need for which one of our clinical trials is likely to help.”

COVID-19 has introduced a more immediate problem, Dr. Oyer said. In the midst of this public health crisis, patients currently participating in clinical trials may be unable or hesitant to continue receiving treatment. Contributing disruptions have included not only orders to remain at home and local transportation shutdowns, but also reduced clinical staffing when nurses are asked to work in other crowded hospital departments.

In response to these issues, Dr. Oyer says it is important to consult with recent clinical trial guidance from the Food and Drug Administration (FDA) and National Cancer Institute (NCI), which contain recommended responses to conditions that may be brought on by COVID-19. “[These] include the potential inability of patients to get to a [treatment] center, local rules that may govern travel, who should come in, patients on a clinical trial who get sick, clinical trial staff that may get sick, or clinical trial staff that may need to be pulled to cover other areas when their coworkers are ill,” Dr. Oyer told Targeted Oncology. “All of those have played a role in what clinical trial leaders are outlining for how to cope with these disruptions.”

Guidance Available

An FDA Guidance addressing how to deal with the issues that are arising in clinical trials in this time of COVID-19 is directed toward industry, investigators, and institutional review boards. Issued March 20, it includes recommendations for the Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic. The guidance covers considerations for ongoing trials, policies, and procedures that can be put into place for trials that are impacted by COVID-19.

Similarly, the NCI Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP) released interim guidance on March 13 and March 23 to provide “clarification on measures to address some of the current challenges in providing care to patients enrolled in clinical trials supported by CTEP and the NCORP in order to mitigate immediate hazards to the patients.”

A series of guidance documents from the National Institute of Health (NIH) include NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19. Other documents address the NCI Late Application Policy, Flexibilities Available to Applicants and Recipients of Federal Financial Assistance, and Proposal Submission and Award Management Related to COVID-19.

In addition to this guidance, says Dr. Oyer, ACCC and other stakeholder organizations are working to fill in the information gaps that the pandemic has uncovered. ACCC’s continually updated COVID-19 Response Page includes a list of resources and access to recorded and upcoming ACCC webcasts and mini-podcasts on how oncology providers can best respond to the pandemic. On April 3, Dr. Oyer will host the webinar, Clinical Trials Amid COVID-19. The webinar requires registration and is free.

ACCC members also have access to the ACCCExchange online forum to post questions and connect in real-time with colleagues to share ideas on how to maintain quality cancer care delivery during the COVID-19 health emergency. 

Eye Toward the Future

When Dr. Oyer was considering the theme for his ACCC presidency, he could not have imagined the meaning it would take on within a global pandemic. His call to strengthen and expand clinical trials in community practices will become even more compelling when the healthcare system must deal with the aftereffects of COVID-19. Advancing knowledge and treatments for cancer will require renewed commitment across the oncology care community, particularly from community programs. 

Dr. Oyer noted at the 2020 AMCCBS that his selection of his theme is a response to the under-utilization of community cancer centers—which serve most of this country’s cancer patients—as sites for clinical trials. Dr. Oyer believes that as the leading education and advocacy organization for the multidisciplinary cancer care team, ACCC is well-positioned to address these issues. 

During his one-year term, Dr. Oyer will lead ACCC’s efforts to create tools to help community cancer programs lay the groundwork for hosting their own clinical trials programs. His proposed deliverables include:

• Creating a multidisciplinary taskforce to summarize the results of membership surveys from ACCC and allied organizations to identify the education and resources needed to accelerate the implementation of clinical trials in ACCC member programs.

   

• Conducting a series of one-day workshops on effective clinical trial program operations. ACCC will bring together experts to share best practices and learn more about surmounting the barriers to starting, growing, or strengthening clinical trial programs.

   

• Leveraging the content from the efforts described above to develop an educational series on effective practices in establishing and sustaining a clinical trials program in the community.
  

For now, says Dr. Oyer, information is the best weapon for mitigating the effects of COVID-19 on clinical trials and all manner of healthcare delivery. “Become a member of the ACCC, ASCO, or another trusted organization so that you can learn from the experience of others,” Dr. Oyer told Targeted Oncology. “Log on to your local department of health; don’t go it alone. Keep yourself and your staff safe so that you can continue to take care of patients.”

Reminder: On Friday, April 3, 3:00-3:30pm EST, Dr. Oyer will host the webinar, "Clinical Trials Amid COVID-19." Participation in the webinar requires registration and is free.