March 2020: EMA Draft Guidance ‘Points to Consider on Implications of Covid-19 on Ongoing Clinical Trials’

The European Medicines Agency (EMA) on March 25th released for consultation a new draft guideline on Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical 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.

Last week the EMA released initial guidance on conducting trials during the pandemic, in tandem with the US FDA guidance along with other regulatory agencies on conducting clinical trials during the COVID-19 Pandemic.

In light of pauses by sponsors regarding on-going clinical trials, 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.

Comments on the draft guideline are due April 25th.

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