The European Medicines Agency (EMA) published a new draft guideline for clinical trials inviting sponsors to evaluate the implications of COVID-19 on methodological aspects of ongoing trials.

This guidance covers actions that sponsors of ongoing clinical trials affected by the coronavirus disease 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.

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.

  • Sponsors should collect a sufficient amount of information on pandemic-related measures and whether trial patients or trial conduct were affected
  • The sponsor should also evaluate information 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, an independent Data Monitoring Committee may be necessary, particularly to help sponsors re-start the usual trial operations, adjust the trial sample size and/or to deal with any potential sources of bias.
  • Patient safety is paramount and at the heart of every decision taken, regardless of any potential consequences for an ongoing trial.
  • 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

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 authorization applications.

The guidance is under a four-week public consultation until 25 April 2020.

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

Meditrial can help – Contact us for immediate support

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials: