The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline on points that clinical trial sponsors should consider on the implications of the coronavirus disease (Covid-19) on methodological aspects of ongoing trials.
While noting that ?it is not possible to give general applicable advice on how the different aspects related to the pandemic should be handled, as implications on clinical trials are expected to be manifold,? the EMA?s Biostatistics Working Party calls on sponsors ?to pre-plan how systematic deviations resulting from the measures and individual decisions related to the Covid-19 pandemic are captured,? as well as to record such deviations and the related reasons for them.
The guidance comes as last week the EMA released initial guidance on conducting trials during the pandemic, in tandem with the FDA. Since then, Eli Lilly said it will delay most new study starts and pause enrollment in most ongoing studies. And Bristol Myers Squibb said that for both ongoing and new studies, no new sites will be activated until 13 April ? a date that could be extended. BMS also temporarily suspended screening, enrollment and apheresis in its cellular therapy clinical trials.
In light of such pauses, the EMA guideline notes that sponsors should collect a ?sufficient amount of information on pandemic-related measures and whether trial patients or trial conduct were affected, as well as on the subpopulations of exposed/non-exposed, and infected/non-infected patients will be necessary to study the impact on the treatment effect. Sponsors should collect this information to the extent feasible, and in a pragmatic manner.?
In some cases, the guideline says an independent Data Monitoring Committee may be necessary, particularly to help sponsors re-start usual trial operations, adjust the trial sample size and/or to deal with any potential sources of bias.
Most importantly, patient safety is paramount and at the heart of every decision taken, regardless of any potential consequences for an ongoing trial. Beyond this, it is an ethical mandate to proceed with a trial that has been started as long as there is an opportunity that the efforts taken by patients and physicians can benefit drug development and patient care,? the guideline adds.
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RAPS: First published in Regulatory Focus? by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.