Addressing Coronavirus concerns in clinical research
By Kathryn E. Vinson, MS, CCRC

I think it is fair to say that those of us in the healthcare world have mixed feelings about the novel Coronavirus (COVID-19). As healthcare and research professionals, we understand that healthy kids, teens, and adults are in low-risk categories when it comes to infection and illness with this virus, but we also understand that certain patient populations are at the highest risk. Cancer patients, patients with cardiovascular and respiratory conditions, diabetes, and hypertension have all been reported by the WHO to experience far greater mortality rates due to COVID-19. Why does this list sound so familiar? Oh yeah, it’s the list of about 90% of the indications on any given study roster (yes, I made up that number, but just take a look at enrolling trials at clinicaltrials.gov and tell me I’m wrong).

Fortunately for all of us in healthcare and research, we have some of the best and brightest minds in the world focused on mitigating the threat of this virus not only from clinical perspectives but also from a logistical standpoint. Both the FDA and the EMA have issued guidance to mitigate risks to not only our research participants but also the integrity of the trial itself. It is important for us to remember that some of these changes may be considered protocol deviations, for which the regulatory bodies have stated their understanding. If changes to the protocol are required, be sure to note any and all deviations until the new protocol is approved and in place. Some of these changes for late phase studies could include:

  • Utilizing web conferencing or offering in-home visits instead of making the patient come to the site.
  • Shipment of investigational products directly to the participant. If this option is utilized, remember that drug accountability and storage standards remain in effect.
  • Allowing participants to use commercial labs and imaging centers rather than labs on site.

It is vital also to remember that changes such as these may require updates to your FDA Form 1572 (in reference to location of study services and providers).

Phase I, healthy normal trials also pose a concern, especially where inpatient periods are concerned. Other considerations include the availability of personal protective gear, lab equipment, and trained personnel (that may have been called in for work as essential service providers). From this standpoint, we need to take precautions for any large group of people in close quarters, if trials such as these are permitted in your state, province, or country. Ideas for these circumstances may include:

  • Delaying check in until all volunteers have completed a two-week symptom-free period.
  • Symptom and temperature check diaries during the screening period (while this would be considered a local policy, double-check with your IRB on the need for approval).
  • Instruction on proper hand washing procedures at check-in.
  • Increasing hand sanitizer stations throughout the facility.

As clinical research professionals, human subject protection is always first and foremost in our minds. Here preparedness and knowledge are key. At DZS, we are ready to help our partner sites with these challenges. From protocol amendments to assistance with regulatory filings to brainstorming sessions for risk mitigation, as your direct line to improved clinical trial performance and efficiency, we are here to help make it through this outbreak of a novel virus together.

Sources:
https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf
https://www.fda.gov/media/136238/download
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf