FDA Guidance: Q+A on Clinical Trial Operations Amidst COVID-19

New Information on site accessibility, informed consent, technology and more

Since issuing their initial guidance in mid-March on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, the FDA has provided additional clarity in the form of an Appendix answering recent inquiries they’ve received from the life science industry.  The FDA plans to continually iterate this guidance and addressing new questions as they arise (see page 10).

We recently published a synopsis of the guidance, and in this new article, I focus on three additional areas, vital to successful clinical study completion and to  keep participants, study staff and investigators safe during the COVID–19 pandemic.

The Q&A addresses these items:

• Ability, desire and safety of study participants to continue to visit a study site location in person
• Possibility for securing informed consent from patients in isolation or quarantine due to COVID-19 infection control mandates
• Availability of technology used to support clinical studies

Study Participants & Continued Ability to Access a Study Site

As a result of COVID-19, the increased risk of traveling anywhere using public or commercial transportation and interacting with dozens or hundreds of individuals during the trip would make a healthy person think twice.  However, for a clinical trial participant who may be health-compromised, the dangers of such travel are pronounced.

An option which has been on the rise and lends itself to cases where investigational medication can be self-administrated involves delivering medications directly to study participants using a car service or rideshare app.

In this scenario, the new FDA guidance FAQ implores sponsors to consider the storage conditions and stability of a product during transport as well as being able to maintain control over the chain of custody of the investigational product.

Informed Consent in the Age of COVID-19

“FDA regulations generally require that the informed consent of a participant be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent (21 CFR 50.27(a)).”

In the time of this global pandemic, the FDA offers a number of flexible options to deal with circumstances that may prevent the ability to secure informed consent through traditional means, namely:

• use of electronic signature where feasible
• three-way call or video conference between an investigator/designee, the patient and an impartial witness. Additional participants may be included at the patient’s request
• in the event that a signed consent cannot be collected from the patient, a photograph of signed consent forms may be included in the record with attestation from the person who submitted the photograph about how it was obtained and that it contains the informed consent of said patient
• “If the patient is unable to provide informed consent and there is a legally authorized representative, investigators must obtain consent from the participant’s legally authorized representative in accordance with 21 CFR 50.27(a).”

Availability of Technology to Support Clinical Trials

Finally, and perhaps most apparently, technology is in every aspect of our lives, including the field of clinical study.  Beyond the CTMS, AE monitoring and electronic submissions systems, there are a host of technologies enabling study conduct.  Any outsourced or vendor-supplied software product or service will need to be top of mind for sponsors.  Availability and uptime of those critical applications and the vendors and service providers that operate and maintain them will require sponsor due diligence.  Contacting service providers to verify they are able to continue operations during the COVID-19 crisis and what if any, capabilities will be diminished or delayed will force sponsors to consider potential workarounds or manual processes.  The good news is that many modern technology providers are able offer high availability of their systems and services due to cloud and SaaS architecture of the solutions in question.

Humanity: Clinical Trials at their Core

When we sit back and think about the big picture, the most important element of any clinical study are the people – the patients, their families, healthcare employees and sponsors. Without each other, research would be impossible as would the full spectrum of innovation that helps to propel the future of medicine.

Thus, in this time of heightened health risk and awareness, please continue to focus on the safety, health and rights of study participants, investigators and study site staff above all.