The US Food and Drug Administration (FDA) last week updated its guidance from earlier this month on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.
The update comes as other regulatory authorities offer updates on managing new or ongoing clinical trials during the outbreak and as pharma companies have begun to halt or alter ongoing trials. Both European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have provided their own guidance on conducting clinical trials amid during the outbreak, with EMA also offering methodological considerations for impacted trials.
FDA Q&A
FDA’s updated guidance features a new appendix with ten questions and answers offering more specifics on how sponsors should manage clinical trials amid the pandemic based on questions the agency has received from sponsors so far. The remainder of the guidance is unchanged from the previous version.
In recent weeks, Pfizer, Eli Lilly, Bristol-Myers Squibb and Vertex have said they are halting new clinical trials as a result of COVID-19 and other drugmakers have announced impacts on some studies.
In the first item in the appendix, FDA explains the key factors sponsors should weigh when deciding to suspend, continue or initiate a new study during the pandemic.
FDA also offers insights on whether sponsors should continue to administer investigational products to participants if they appear to be benefiting from them.
“A sponsor deciding whether to continue administering or using such a product during the COVID-19 pandemic should carefully consider context-dependent issues, including whether a trial participant appears to be benefitting from treatment with the investigational product, whether there are reasonable alternative treatments, the seriousness of the disease or condition being treated, and the risks involved in switching to an alternative treatment if necessary,” FDA writes, noting that there may be situations in which it may be necessary to halt a drug’s administration during a trial.
FDA also expands on how to handle protocol deviations and amendments in relation to COVID-19 and how to submit formal amendments or supplements for trials conducted under an investigational new drug (IND) application or investigational device exemption (IDE).
To continue ongoing clinical trials, many sponsors may be looking at ways to conduct virtual patient visits in lieu of on-site visits. FDA says such changes to protocol “can be immediately implemented with subsequent review by the IRB [institutional review board] and notification to FDA.”
FDA says it recognizes that reporting deviations within the five working day timeframe for IDE studies may be challenging and says that “sponsors may consolidate implemented deviations … and should update FDA as soon as possible.”
The guidance also provides recommendations for handling home delivery of investigational products; considerations for switching from facility to home infusion; delays in on-site monitoring; and obtaining signed informed consent for patients who are in isolation due to COVID-19.
MHRA
On Tuesday, MHRA said it has written to sponsors conducting Phase I clinical trials to confirm they have conducted a risk assessment for the potential impact of COVID-19 on their studies.
“This action will help to ensure the safety of participants and the public, as well as avoid any adverse impacts on the capacity of [National Health Service] NHS front line services at this very challenging time,” MHRA writes, noting that the action does not apply to studies for potential treatments for COVID-19.
MHRA says it expects that some trials “may be temporarily halted or terminated,” while others may continue if “clearly justified.”
TGA
Australia’s Therapeutic Goods Administration (TGA) on Tuesday posted a clarification about when clinical studies may proceed in relation to its clinical trial notification (CTN) scheme and explained situations where sponsors do not need to notify the agency of variations to their studies due to COVID-19.
TGA explains that its acknowledgment of a CTN “is an administrative process and, for our purposes, is not required before the trial can begin.” TGA notes that some human research ethics committees (HRECs) require TGA acknowledgement of a CTN before allowing a study to proceed but says it will accept CTN forms “while the sponsor is obtaining any required approvals from the HREC and approval authorities.”
In Australia, HRECs are analogous to IRBs, while approving authorities are defined as “the institution or organisation at which the trial will be conducted.”
TGA says it anticipates some deviations from trial protocols due to COVID-19 quarantines and travel restrictions do not need to be provided to the agency. TGA also says sponsors do not need to notify it of changes to trial start/finish dates, product information, numbers of participants or the name of the trial approving authority if the changes are due to COVID-19.
To continue reading this article please go to RAPS .