The European Commission, European Medicines Agency (EMA) and the Head of Medicines Agencies on Friday released guidance for biopharma companies that may need to adjust their clinical trials during the COVID-19 pandemic.
Similar to guidance issued by the US Food and Drug Administration on Wednesday, the EMA’s 8-page guidance discusses how to deal with the extraordinary situations that the pandemic presents. It also includes specific advice on trials for COVID-19 treatments.
Specific measures that sponsors may want to consider, according to the guidance, include the conversion of physical patient visits into phone or video visits, a temporary halt of a trial at some or all trial sites, the suspension or slowing down of recruitment of new trial participants, the extension of the duration of the trial, and/or the postponement of trials or activation of sites that have not yet been initiated.
“When changes in ongoing trials are considered, the overall well-being and best interests of the participant should be also considered, for example in trials for patients with life-threatening or severely debilitating conditions, when participants require to stay on trial treatment. In cases, when trial halt, even if temporary only, can potentially compromise the overall well-being and best interest of trial participants, all measures need to be considered and taken to avoid this,” the guidance says.
For participants enrolled in ongoing trials who may be at risk for COVID-19 or who are in trials involving therapies which may increase such risk, the potential impact of COVID-19 “should be carefully considered when deciding to start or continue such trials,” EMA says.
On the issue of informed consent, the guidance notes that if a sponsor plans to initiate a trial aiming to test new treatments for COVID-19, “advice should be sought on alternative procedures to obtain informed consent, as it is likely that the physical consent cannot leave the isolation room, and therefore is not appropriate as trial documentation.”
As far as clinical trial site monitoring, if it remains feasible, the guidance says sponsors “should take into account national and local restrictions, the urgency (e.g. source data verification can often be postponed) and the availability of site staff, and should only be performed as agreed with investigator sites. The burden of the introduction of any alternative measures for the site staff and facilities should also be considered in order to strike an acceptable balance between appropriate oversight and the capacity of and possibilities at the site.”
When sponsors might need to deviate from a trial protocol, the guidance adds: “An increase in protocol deviations in relation to the COVID-19 situation will in itself not trigger the actions required by GCP § 5.20. They will however need to be assessed and reported in the clinical study report, following ICH E3.”
EMA also notes that this is just the first version of this guidance.
“Due to the urgency, this guidance is issued without prior public consultation. The sponsors should note that due to the rapidly evolving situation further updates to this guidance are possible and likely,” the guidance says.
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