Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

This guidance covers actions that sponsors of ongoing clinical trials affected by the coronavirus disease (COVID-19) pandemic should take to help ensure the integrity of their studies and interpretation of study results while safeguarding the safety of trial participants as a first priority. These include:

  • documenting deviations from the study protocol due to COVID-19 and explaining the reasons;
  • conducting a risk assessment of the impact of COVID-19 on the trial, if needed by an independent party, and on blinded data;
  • engaging early with regulatory authorities (e.g. through scientific advice) to agree any changes to study protocols or statistical analysis plans.

This complements the good clinical practice guidance on how sponsors should adjust the management of clinical trials and participants during the COVID-19 pandemic. 

EMA's Biostatistics Working Party encourages affected clinical trial sponsors to seek scientific advice on these matters. EMA’s Scientific Advice Working Party will review requests for scientific advice within 40 days and may consult the Biostatistics Working Party.

In line with this guidance, EMA will be flexible and pragmatic during the assessment of affected clinical trial data submitted to the Agency as part of marketing authorisation applications.

The guidance underwent a four-week public consultation between 25 March and 25 April 2020.

Please note that further updates are possible and likely given the rapidly evolving nature of the pandemic.

Keywords: COVID-19, ongoing clinical trials, protocol deviations, data collection, trial integrity, interpretability, DMC, scientific Advice

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