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:

1. Assuring safety of clinical trial participants

2. Maintaining compliance with Good Clinical Practice (GCP)

3. Minimizing risks to trial integrity during the COVID-19 pandemic

Although this guidance does not apply to all usability studies, it does apply to clinical usability studies and usability assessments conducted as part of clinical trials.

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

FDA recognizes that these difficulties may result in protocol deviations or the need to issue a protocol amendment.

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:

1. Contingency measures implemented to manage study conduct during disruption of the study as a result of COVID-19 control measures.

2. A listing of all participants affected by the COVID-19 related study disruption by unique subject identification number and by investigational site, and a description of how the individual’s participation was altered.

3. 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 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.