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Regulatory Focus™ > News Articles > 2020 > 4 > FDA, EU authorities update guidance on clinical trials during COVID-19

FDA, EU authorities update guidance on clinical trials during COVID-19

Posted 28 April 2020 | By Michael Mezher 

FDA, EU authorities update guidance on clinical trials during COVID-19

The European Commission and European Medicines Agency (EMA) on Tuesday updated their guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, adding advice on distribution, data verification and communicating with authorities.
 
The updated guidance follows a recent similar update from the US Food and Drug Administration (FDA), which added seven new questions and answers to its document.
 
European Commission guidance
 
The update marks the third version of the guidance from the Commission, EMA and the Heads of Medicines Agencies and provides new recommendations on the distribution of investigational medicinal products (IMPs) and data verification under social distancing measures and resource limitations.
 
The guidance also clarifies how clinical trial sponsors should communicate urgent issues to regulatory authorities.
 
“The aim is to mitigate the disruption of clinical research in Europe and therefore the negative effects of the pandemic, without compromising on quality and safety,” the Commission said, noting that the guidance will be revoked once the crisis in Europe has passed.
 
The updated guidance explains that sponsors may consider changes in how IMPs are distributed to avoid treatment interruptions.
 
“Such measures raise various practical considerations, including whether the IMP is appropriate for administration and general storage at the trial participant’s home, how the stability of the product will be maintained during transit (especially for a cold chain product), how safe custody of products will be ensured and how IMP accountability and the evaluation of compliance to treatment (as defined in the protocol) will be managed,” the guidance states.
 
In a section covering changes to trial monitoring, the guidance explains that remote source data verification (SDV) will only be considered for clinical trials involving products to treat or prevent COVID-19 or in the final data cleaning steps for pivotal trials of products for serious or life-threatening conditions that lack sufficient treatment options.
 
Additionally, the guidance provides a set of examples of how to classify mitigating measures taken in clinical trials when communicating those changes to authorities.
 
FDA update
 
In seven new questions and answers, FDA provides guidance on obtaining informed consent during the pandemic; considerations for remote clinical outcome assessments; remote site monitoring; electronic common technical document (eCTD) waivers; and other issues.
 
FDA explains that when investigators do not have electronic informed consent capabilities, they may use other methods “if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject.” FDA says this could be achieved via fax or email, with consent interviews taking place by phone.
 
For sponsors considering remote performance outcome (PerfO) and interview-based clinician-reported outcome (ClinRO) assessments during the pandemic, FDA says considerations must be made to determine whether remote assessments are appropriate for the data they are meant to collect.
 
In cases where some assessments are done on-site and others remote, FDA says sponsors “should perform the remote assessments in a manner as similar as possible to the assessments being conducted on-site.”
 
As for site monitoring visits, FDA says its regulations “are not specific about how sponsors must conduct such monitoring and are therefore compatible with a range of approaches to monitoring,” and that some aspects of site monitoring visits may be done remotely.
 
FDA explains that sponsors may qualify for a short-term waiver from eCTD requirements if they are experiencing technical difficulties but should contact FDA’s electronic submission staff before requesting a waiver.
 
The guidance also provides considerations for situations where patients are unable to travel to a trial site to receive investigational products that need to be administered via infusion, providing recommendations for documenting changes in trial protocol and shipping investigational products to health care providers.
 
Additionally, FDA says that for studies that do not require randomization and involve commercially available treatments, “local sourcing of the product(s) would be acceptable” and that the agency would not consider this to be the same as a sponsor charging for an investigational drug under and investigational new drug application (IND). FDA also says that sponsors may reimburse patients for costs incurred in such cases.
 
European Commission, FDA

Tags: coronavirus, EU, US

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