In CRO, Phase 1 Clinical Trials

Volunteer Safety in the Age of COVID-19

Earlier this year, we published an E-book entitled Getting Phase 1 Trials Right the First Time: A Professional Guide for Clinical Trial Personnel, where we explored different aspects of planning and managing Phase 1 clinical trials and discussed strategies for conducting these trials successfully in extensive detail. (Download the E-book here).

Included in the E-book was a piece entitled “The Most-Needed Resource for Successful Phase 1 Trials”, written by our Chief Medical and Operating Officer, David Nguyen, M.D., M.B.A., which focused on the need for treating clinical trial volunteers with great respect, care, and appreciation, in order to better foster a community of dedicated and informed research participants who feel appreciated for the contributions they are making to healthcare innovation.

Just a few months later, in a world that is now so different than when those words were first written, we feel it necessary to revisit the sentiment and consider what it means to actively care for clinical research volunteers during the COVID-19 pandemic.

Volunteer Safety in the Age of COVID-19

Typically, Phase 1 clinical trials will require that volunteers be confined to an overnight facility for a pre-determined amount of time to enable supervised drug administration, serial PK sample collection, time-pointed procedures, and strict compliance with the study protocol in terms of diet, activity, and use of concomitant medications.

Thus, unlike other phases of clinical research where visit schedules allow for more flexibility and at-home dosing, much of what’s entailed in Phase 1 trials cannot be performed virtually and volunteers must instead come to a physical space which requires contact with medical professionals. In order to conduct these trials safely, we recommend the following measures be implemented at your facility:

  1. Frequent COVID-19 Testing

    This isn’t simply checking a volunteer’s temperature or asking a few questions about travel, illness, and living situation. A proper testing platform involves screening for the presence of the COVID-19 infection with an approved testing platform, such as an antibody test or a nasal swab PCR test, every time they arrive for screening, inpatient confinement, or outpatient visits. The last thing you want is for one infected volunteer to spread the infection to the others, jeopardizing your study.

  2. Limit Non-Essential Access

    It’s no secret that many top-performing businesses around the world are transitioning to a remote working model where appropriate. While your Phase 1 clinical trial will need to include various staff members, consider allowing employees who will not directly work on the trial to perform their duties from home to limit the number of people who will be present at the trial site at any given time. Examples of such staff members may be Project Managers, Regulatory personnel, or CRAs.

  3. Capacity Limitations

    In addition to the previous item, consider adjusting the facility’s overall capacity for volunteer screening and overnight confinement. While the Phase 1 unit may have the ability to accommodate hundreds of volunteers at any given time during normal circumstances, consider reducing that capacity to allow for volunteers and staff to have more space between them. This is in compliance with current health and safety “social distancing” guidelines.

  4. Flexible Site Configuration

    Typically, facilities that conduct trials with overnight confinement or extended stays will maintain common areas for trial volunteers. While these areas may have been favored by volunteers, it is more important to keep them safe by temporarily closing off these areas to limit volunteer-to-volunteer contact. Furthermore, some sites may opt to re-purpose these spaces into additional procedural or confinement areas, which helps to alleviate challenges caused by the previous point.

  5. Designate a “Quarantined” Area

    In the event that a volunteer is showing symptoms of the infection or continued testing demonstrates a rise in antibodies during their confinement, it is important to have an area where procedures and assessments can be performed in complete isolation from other volunteers until the presence of the virus can be confirmed by PCR testing.

  6. Contact Tracing

    When it is confirmed that a volunteer carries the infection, identifying anyone with whom the volunteer may have come into contact with and performing confirmatory testing on those individuals are necessary steps towards reducing the potential further spread of the infection

  7. Enhanced Cleaning Protocols

    As an additional precaution to the above measures, we recommend increasing the frequency of cleaning at Phase 1 sites to ensure that entire areas, individual seats or tables, and any equipment used are disinfected after each use. Making items such as hand sanitizer and disinfecting wipes available throughout procedural areas can aid in this effort.

  8. Educate and Communicate

    While the staff at a clinical pharmacology unit can perform all of the above tactics to keep volunteers safe and limit the spread of COVID-19, there must be some responsibility taken by the volunteers themselves to remain safe while they are not under observation or in the care of trained medical professionals. We encourage Phase 1 sites to educate current and potential volunteers on how to best stay safe and healthy during this time and prepare them for what to expect during their visits. Sharing resources such as CDC guidelines, local health regulations, and health tips published by scientifically and medically reputable sources can empower them to keep themselves and those around them as safe as possible.

Beyond the above, its important to understand that the landscape is constantly changing as we continue to learn more about COVID-19. As such, Phase 1 units must be flexible in their approach towards preventing the spread of the infection and be ready to adopt new approaches, or amend old ones, based on emerging evidence, federal and local law, and the prevalence of the pandemic in their regions.

Join our upcoming webinar to learn more about conducting Phase 1 clinical trials during the COVID-19 pandemic.

Upcoming webinar

When Trials Can’t Go Virtual: Conducting Phase 1 Clinical Trials During the COVID-19 Pandemic

WCCT will draw upon experience and data gained within its Phase 1 clinical pharmacology unit to present a stepwise approach for conducting trials under COVID-19.

Date and Time:

Tuesday, October 20, 2020 | 2pm EDT (11am PDT) 60 min

Speakers:

Mel Affrime, PharmD, President & Chief Scientific Officer

David Nguyen, MD, MBA, Chief Medical and Operations Officer

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