FDA updates guidance on clinical trials amid COVID-19
Posted 13 May 2020 | By Michael Mezher
FDA updates guidance on clinical trials amid COVID-19
The US Food and Drug Administration (FDA) this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address new questions, including the use of alternate laboratory or imaging centers, video conferencing and postmarketing requirements.
The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take when considering administering investigational products at home instead of at clinical trial sites. (RELATED: FDA unveils guidance for trials impacted by COVID-19, Regulatory Focus 18 March 2020; Clinical trials during COVID-19: Updates from FDA, MHRA and TGA, Regulatory Focus 1 April 2020; FDA, EU authorities update guidance on clinical trials during COVID-19, Regulatory Focus 28 April 2020).
Updates
For protocol deviations and amendments to ongoing trials, FDA now says that deviations should be included in final study reports and can be included in annual reports. The agency also explains that for device studies conducted under an investigational device exemption, the requirements to get FDA approval before making changes to an investigational plan “do not apply to changes made to protect the life or physical well-being of a subject in an emergency, including study-wide changes, but such deviations must be working days.”
In another change from earlier versions of the guidance, FDA says it expects sponsors to perform a risk assessment when considering alternative arrangements for administering investigational products via infusion, such as at a patient’s home. FDA says the risk assessment should consider “the nature of the investigational product and the potential risk to both the trial participants and the health care providers responsible for administering the product at the alternative site.” Sponsors are then instructed to contact the appropriate review division at the agency to discuss their plans.
New questions
The updated guidance includes three new questions and answers, bringing the total number to 20, that address the use of alternate laboratory or imaging centers, remote participant visits via video conferencing and postmarketing requirements for drugs, biologics and medical devices.
FDA says that, “Sponsors should evaluate whether it is feasible to use alternative laboratories or imaging centers,” for protocol assessments as participants may not be able to visit the sites specified in the protocol due to disruptions caused by the COVID-19 pandemic. The agency says that alternative sites are generally acceptable for safety-focused assessments if they routinely conduct similar tests or assessments.
In other cases, such as when the results of the tests or assessments form the basis for primary or secondary efficacy endpoints and certain safety endpoints or for characterizing the eligible study population, FDA says further discussion with the relevant review division is warranted.
The guidance also provides some considerations for sponsors looking to use video conferencing in lieu of participant site visits. Specifically, FDA says that investigators and study personnel should be trained on using telemedicine, and that there should be procedures put in place to protect participant privacy and to confirm the investigators’ and participants’ identities.
FDA also explains that it considers real-time video interactions to be “a live exchange of information between the personnel and trial participants,” and not as electronic records subject to 21 CFR part 11.
Additionally, FDA explains that the guidance applies to postmarketing clinical trials, including postmarketing requirements for drugs and biologics, and says that many of the considerations also apply to postmarket device studies.
FDA says that applicants with postmarketing requirements for drugs and biologics should notify it as soon as possible if they run into delays due to COVID-19 that would impact their ability to meet certain milestones for their studies and propose “feasible revised milestones for interim, trial completion, and/or final report submission.”
Similarly, FDA says that device makers with approved postmarket study protocols or postmarket surveillance plans should inform the agency if they experience any COVID-19 -related delays.
Posted 13 May 2020 | By Michael Mezher
FDA updates guidance on clinical trials amid COVID-19
The US Food and Drug Administration (FDA) this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address new questions, including the use of alternate laboratory or imaging centers, video conferencing and postmarketing requirements.
The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take when considering administering investigational products at home instead of at clinical trial sites. (RELATED: FDA unveils guidance for trials impacted by COVID-19, Regulatory Focus 18 March 2020; Clinical trials during COVID-19: Updates from FDA, MHRA and TGA, Regulatory Focus 1 April 2020; FDA, EU authorities update guidance on clinical trials during COVID-19, Regulatory Focus 28 April 2020).
Updates
For protocol deviations and amendments to ongoing trials, FDA now says that deviations should be included in final study reports and can be included in annual reports. The agency also explains that for device studies conducted under an investigational device exemption, the requirements to get FDA approval before making changes to an investigational plan “do not apply to changes made to protect the life or physical well-being of a subject in an emergency, including study-wide changes, but such deviations must be working days.”
In another change from earlier versions of the guidance, FDA says it expects sponsors to perform a risk assessment when considering alternative arrangements for administering investigational products via infusion, such as at a patient’s home. FDA says the risk assessment should consider “the nature of the investigational product and the potential risk to both the trial participants and the health care providers responsible for administering the product at the alternative site.” Sponsors are then instructed to contact the appropriate review division at the agency to discuss their plans.
New questions
The updated guidance includes three new questions and answers, bringing the total number to 20, that address the use of alternate laboratory or imaging centers, remote participant visits via video conferencing and postmarketing requirements for drugs, biologics and medical devices.
FDA says that, “Sponsors should evaluate whether it is feasible to use alternative laboratories or imaging centers,” for protocol assessments as participants may not be able to visit the sites specified in the protocol due to disruptions caused by the COVID-19 pandemic. The agency says that alternative sites are generally acceptable for safety-focused assessments if they routinely conduct similar tests or assessments.
In other cases, such as when the results of the tests or assessments form the basis for primary or secondary efficacy endpoints and certain safety endpoints or for characterizing the eligible study population, FDA says further discussion with the relevant review division is warranted.
The guidance also provides some considerations for sponsors looking to use video conferencing in lieu of participant site visits. Specifically, FDA says that investigators and study personnel should be trained on using telemedicine, and that there should be procedures put in place to protect participant privacy and to confirm the investigators’ and participants’ identities.
FDA also explains that it considers real-time video interactions to be “a live exchange of information between the personnel and trial participants,” and not as electronic records subject to 21 CFR part 11.
Additionally, FDA explains that the guidance applies to postmarketing clinical trials, including postmarketing requirements for drugs and biologics, and says that many of the considerations also apply to postmarket device studies.
FDA says that applicants with postmarketing requirements for drugs and biologics should notify it as soon as possible if they run into delays due to COVID-19 that would impact their ability to meet certain milestones for their studies and propose “feasible revised milestones for interim, trial completion, and/or final report submission.”
Similarly, FDA says that device makers with approved postmarket study protocols or postmarket surveillance plans should inform the agency if they experience any COVID-19 -related delays.
