FDA Guidance Relating to Clinical Usability Studies During the COVID-19 Pandemic

FDA issued a guidance on
March 19, 2020 regarding clinical trials during the COVID-19 pandemic and to
provide general considerations to assist sponsors in:
FDA recognizes that COVID-19 illness or control measures may impact clinical trials of medical products and may cause difficulties in adhering to protocol requirements and procedures such as the following:
This FDA guidance outlines considerations for ongoing trials, establishing and implementing necessary policies as a result of the pandemic, and required documentation.
The FDA describes considerations for ongoing studies. A guide of consideration highlights is presented below:
Sponsors, clinical investigators, and IRBs are expected to establish and implement (or update) policies and procedures to protect clinical trial participants and manage study conduct during disruption of the study as a result of any control measures for COVID-19. Policy changes could address the following:
Study Reporting
for Clinical Trials Impacted by COVID-19
FDA expects the clinical study report (or separate study-specific document) to document:
For a complete list of considerations and requirements, you can access the full FDA final Guidance here.
Although it is not specifically covered in the recent Guidance, groups conducting a Clinical Usability Study also need to have policies and procedures in place to assure the safety of study personnel involved in the study (e.g. appropriate personal protective equipment worn during observation, other protective measures in place).
Considerations
for Non-Clinical Usability Studies
Any study involving human participants – including Non-Clinical Usability Studies – will need to be adapted to ensure the safety of study participants and study staff (e.g. moderators, observers, those who set up the room). This could mean canceling the study, if that is determined to be the safest course of action. Participants and staff should be alerted regarding any study cancellations or changes that may affect them.
Recommended changes include:
Next steps
Are you planning a Non-Clinical Usability Study or a Clinical Usability Study? UserWise is available to help you through the process. Contact us today to set up a free 1 hour consult for your project and learn more about our usability engineering services and expertise. Also, check out the blog posts below with helpful resources for product development during the COVID-19 pandemic.
︎Denise Forkey & Ali Decker | March 19, 2020
-
Assuring safety
of clinical trial participants
-
Maintaining
compliance with Good Clinical Practice (GCP)
- Minimizing risks to trial integrity during the COVID-19 pandemic
FDA recognizes that COVID-19 illness or control measures may impact clinical trials of medical products and may cause difficulties in adhering to protocol requirements and procedures such as the following:
- Administering or using the investigational product
- Adhering to protocol-mandated visits
- Complying with laboratory/diagnostic testing
This FDA guidance outlines considerations for ongoing trials, establishing and implementing necessary policies as a result of the pandemic, and required documentation.
Considerations for Ongoing Clinical Trials
The FDA describes considerations for ongoing studies. A guide of consideration highlights is presented below:
Implementation of Policies and Procedures around COVID-19
Sponsors, clinical investigators, and IRBs are expected to establish and implement (or update) policies and procedures to protect clinical trial participants and manage study conduct during disruption of the study as a result of any control measures for COVID-19. Policy changes could address the following:
-
Impact on the
informed consent process, study visits and procedures
-
Methods for data
collection, study monitoring, and adverse event reporting
-
Changes in
investigators, site staff, and/or monitors as a result of travel restrictions,
quarantine measures, or the illness itself
Study Reporting
for Clinical Trials Impacted by COVID-19
FDA expects the clinical study report (or separate study-specific document) to document:
- Contingency
measures implemented to manage study conduct during disruption of the study as
a result of COVID-19 control measures.
-
A listing of all
participants affected by the COVID-19 related study disruption by unique
subject number identifier and by investigational site, and a description of how
the individual’s participation was altered.
- Analyses and corresponding discussions that address the impact of implemented contingency measures (e.g. trial participant discontinuation from investigational product and/or study, alternative procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the study.
For a complete list of considerations and requirements, you can access the full FDA final Guidance here.
Although it is not specifically covered in the recent Guidance, groups conducting a Clinical Usability Study also need to have policies and procedures in place to assure the safety of study personnel involved in the study (e.g. appropriate personal protective equipment worn during observation, other protective measures in place).
Considerations
for Non-Clinical Usability Studies
Any study involving human participants – including Non-Clinical Usability Studies – will need to be adapted to ensure the safety of study participants and study staff (e.g. moderators, observers, those who set up the room). This could mean canceling the study, if that is determined to be the safest course of action. Participants and staff should be alerted regarding any study cancellations or changes that may affect them.
Recommended changes include:
-
During recruitment, or before a scheduled participant
arrives, each participant will need to be asked additional questions to
determine if they are showing signs of COVID-19 and so should be disqualified.
Participants who are cleared during recruiting will also need to be reviewed
for signs of COVID-19 when they arrive to the study session. The participant should be dismissed if they
show these signs prior to the session or at any time during the session.
-
Similarly, if a study staff are exhibiting signs of
COVID-19, they should be prohibited from involvement in the study.
-
Additionally, adequate space between study staff and
the participant should be maintained where possible.
- Between participants, the study room as well as any waiting areas, must be disinfected. Adequate time must be allowed between sessions to disinfect all surfaces, including study articles and equipment.
Next steps
Are you planning a Non-Clinical Usability Study or a Clinical Usability Study? UserWise is available to help you through the process. Contact us today to set up a free 1 hour consult for your project and learn more about our usability engineering services and expertise. Also, check out the blog posts below with helpful resources for product development during the COVID-19 pandemic.
︎Denise Forkey & Ali Decker | March 19, 2020
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