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Conducting Research During the COVID-19 Pandemic

 

April 30, 2020

Conducting Research During the COVID-19 Pandemic

By Karin Choquette, MSN, AGNP-C, CCRC, Arizona Oncology/The US Oncology Network, and Jason Astrin, PA-C, MBA, DFAAPA, The US Oncology Network

The COVID-19 pandemic has had a tremendous impact on the conduct of clinical trials worldwide. As the situation rapidly evolves across the globe, sponsors, clinical research organizations (CROs), and research sites are committed to anticipating, mitigating, and adapting to the various challenges and implications this pandemic has had on clinical trial operations, enrolled patients, and research staff’s ability to safely manage and adhere to protocol related requirements.

Shelter-in-place requirements, closure, reduced hours of research sites, and patients refusing to travel to clinical sites for protocol-required visits are just a few of the many challenges industry sponsors and investigators are facing. Clearly, the oversight and safety of patients enrolled in clinical trials, along with the safety of research and ancillary staff, is of the utmost importance and must be the hallmark of any risk mitigation plan developed to address the COVID-19 crisis. In addition to protecting patients and staff, data integrity remains critically important and should be considered when developing any kind of risk mitigation plan.

Industry Response

As such, the industry response to COVID-19 is all over the map, ranging from complete shutdown of research operations to business as usual. Institutions that have remained open to research have likely put significant restrictions in place for patients and staff safety that make protocol compliance exceedingly difficult. Creative approaches and collaborations to address these difficulties will perhaps break down archaic processes and admirative roadblocks and pave the way for new, better ways of conducting research in a COVID-19–free future.

Responding to COVID-19

Current recommendations from local, federal and global authorities must be taken into consideration when deciding how to respond to this pandemic. Thoughtful preparation and implementation of any mitigation plan should ensure site recognition of their own ability to enforce such plans based on institutional and practice guidelines, availability of resources, and most importantly, patient willingness to participate in a clinical trial during these uncertain times. In the oncology/hematology setting, treatment as part of a clinical trial is often the best treatment choice and in some cases, the only treatment choice.

Communication is of course essential to ensuring successful oversight during this pandemic. The FDA has also appropriately weighed in and in March of this year published the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic; Guidance for Industry, Investigators, and Institutional Review Boards (FDA, 2020). Since this publication, industry sponsors and regulatory bodies have demonstrated exceptional support and have been instrumental in working with sites in recognizing site-specific mitigation plans and the successful implementation and enforcement of sponsor-specific mitigation plans.

Categorical recommendations for a risk mitigation plan should include but are not limited to the following:

  • Patient-informed consent and reconsent
  • Patient safety and efficacy monitoring
  • Adverse event and serious adverse event reporting
  • Protocol adherence and deviation reporting
  • Investigational product distribution and IP chain of custody
  • Onsite clinical trial monitoring vs. remote monitoring
  • Storage capacity of additional investigational product
  • Lab kits and supplies and laboratory samples
  • Study start-up to include onsite vs. remote site selection visits and site initiation visits
  • Institutional review board notifications and reporting COVID-19 positive research patients


Understandably, these are uncertain times and clinical trial conduct is a rapidly evolving situation. Mitigation plans are likely fluid and should be amended as needed to align with local and federal guidance and regulations. Lessons are already being learned and perhaps most importantly, the research industry is once again recognizing and validating the importance of coming together with the common mission of caring for our patients and communities. It will be very interesting to see what long-term changes will be made to research operations once we emerge from this crisis.

 

Reference

U.S. Food & Drug Administration (2020). FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic; Guidance for Industry, Investigators, and Institutional Review Boards. Retrieved from https://www.fda.gov/media/136238/download

 


 

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