Conducting Clinical Trials During a Pandemic

By Zach Cahill

April 1, 2020

The growing number of clinical trials the kidney community has enjoyed over the past few years is endangered due to the COVID-19 pandemic. Concerns over the safety of trial participants and investigators are paramount and are leading to rapid changes in the conduct of clinical trials.

The US Food and Drug Administration (FDA) released “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”, updated March 27, to provide clarity to the clinical trial community. Considering this guidance and after soliciting reactions from the clinical trial community, the Clinical Trials Transformation Initiative (CTTI) hosted a webinar on March 31 titled “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID”.

These resources are essential for the kidney community to protect the safety of clinical trial participants and evaluate how to safely conduct trials in this environment.

The FDA’s guidance document encourages industry, investigators, and institutional review boards (IRBs) to consider the safety of trial participants first and foremost. The guidance includes considerations for ongoing trials including:

  • Ensuring the safety of trial participants in all circumstances
  • Determining participation in clinical trials on a case by case basis
  • Evaluating alternative methods for conducting safety assessments
  • Considering what happens if participants no long have access to the investigation products or what sites might need additional safety monitoring
  • Initiating new processes or modifying existing processes to ensure the safety of participants.
  • Reporting COVID-19 screening procedures properly
  • Documenting and reporting changes to protocol with IRBs
  • Ensuring that alternative processes are consistent with existing protocol when possible
  • Capturing specific information related to changes in visit schedules, missing visits or patient discontinuations
  • Consideration of alternative ways to administer investigational products
  • Consultation with appropriate review divisions regarding FDA efficacy considerations
  • Coordination with relevant FDA review divisions if protocol changes led to amending data or statistical analysis.
  • Optimizing use of central and remote monitoring systems  
     

The March 27 update added an appendix with frequently asked questions and answers.

Recordings and slides from CTTI’s recent webinar are now available online. After surveying the clinical trial community, CTTI developed 10 best practices for conducting clinical trials during the pandemic:

  1. Keep Participants Informed
  2. Perform Ongoing Risk Assessment
  3. Pause (Most) New Study Starts & Enrollment
  4. Pivot to Remote Study Visits
  5. Switch to Remote Monitoring
  6. Document with COVID-19 Tag
  7. Communicate with IRBs
     

The National Institutes of Health (NIH) Collaboratory produced a webinar titled “Impacts of COVID-19 on the Conduct of Clinical Trials) on March 24, 2020.  Additionally, the NIH released “Guidance for Clinical Trials Affected by COVID-19” on March 16, 2020. 

The Kidney Health Initiative (KHI), a public-private partnership between the American Society of Nephrology and the FDA, is working through it’s Board of Directors to evaluate the impact of COVID-19 on clinical trials in the kidney community and keep the community informed about new guidance and best practices. Sponsors of clinical trials in kidney diseases can email KHI at khi@asn-online.org to share best practices and/or information that would be beneficial to the broader kidney research community.

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Author:
Zach Cahill
Body:

The growing number of clinical trials the kidney community has enjoyed over the past few years is endangered due to the COVID-19 pandemic. Concerns over the safety of trial participants and investigators are paramount and are leading to rapid changes in the conduct of clinical trials.

The US Food and Drug Administration (FDA) released “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”, updated March 27, to provide clarity to the clinical trial community. Considering this guidance and after soliciting reactions from the clinical trial community, the Clinical Trials Transformation Initiative (CTTI) hosted a webinar on March 31 titled “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID”.

These resources are essential for the kidney community to protect the safety of clinical trial participants and evaluate how to safely conduct trials in this environment.

The FDA’s guidance document encourages industry, investigators, and institutional review boards (IRBs) to consider the safety of trial participants first and foremost. The guidance includes considerations for ongoing trials including:

  • Ensuring the safety of trial participants in all circumstances
  • Determining participation in clinical trials on a case by case basis
  • Evaluating alternative methods for conducting safety assessments
  • Considering what happens if participants no long have access to the investigation products or what sites might need additional safety monitoring
  • Initiating new processes or modifying existing processes to ensure the safety of participants.
  • Reporting COVID-19 screening procedures properly
  • Documenting and reporting changes to protocol with IRBs
  • Ensuring that alternative processes are consistent with existing protocol when possible
  • Capturing specific information related to changes in visit schedules, missing visits or patient discontinuations
  • Consideration of alternative ways to administer investigational products
  • Consultation with appropriate review divisions regarding FDA efficacy considerations
  • Coordination with relevant FDA review divisions if protocol changes led to amending data or statistical analysis.
  • Optimizing use of central and remote monitoring systems  
     

The March 27 update added an appendix with frequently asked questions and answers.

Recordings and slides from CTTI’s recent webinar are now available online. After surveying the clinical trial community, CTTI developed 10 best practices for conducting clinical trials during the pandemic:

  1. Keep Participants Informed
  2. Perform Ongoing Risk Assessment
  3. Pause (Most) New Study Starts & Enrollment
  4. Pivot to Remote Study Visits
  5. Switch to Remote Monitoring
  6. Document with COVID-19 Tag
  7. Communicate with IRBs
     

The National Institutes of Health (NIH) Collaboratory produced a webinar titled “Impacts of COVID-19 on the Conduct of Clinical Trials) on March 24, 2020.  Additionally, the NIH released “Guidance for Clinical Trials Affected by COVID-19” on March 16, 2020. 

The Kidney Health Initiative (KHI), a public-private partnership between the American Society of Nephrology and the FDA, is working through it’s Board of Directors to evaluate the impact of COVID-19 on clinical trials in the kidney community and keep the community informed about new guidance and best practices. Sponsors of clinical trials in kidney diseases can email KHI at khi@asn-online.org to share best practices and/or information that would be beneficial to the broader kidney research community.

Date:
Wednesday, April 1, 2020