EMA calls for transparency and collaboration to ensure high-quality observational research in the context of COVID-19

The EMA has called for transparency and collaboration in observational, real-world data studies conducted in the context of COVID-19, to ensure research is of high quality and impactful.

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The EMA has called for transparency and collaboration in observational, real-world data studies conducted in the context of COVID-19, to ensure research is of high quality and impactful.

Although traditional, randomized controlled clinical trials are essential for evaluating absolute effectiveness of an intervention, observational study results can complement data obtained from these trials and help fill certain knowledge gaps, especially when the conduct of a clinical trial may not be feasible.

In the context of COVID-19, observational studies can help provide supporting evidence on the safety and effectiveness of potential therapeutics and help further understanding of how exposure to certain medicines may impact the risk or severity of COVID-19 infection.


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Indeed, at a recent workshop co-organized by the EMA and Health Canada, under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators agreed on three priority areas for cooperation and collaboration on observational research during COVID-19, to help understand medicines’ use and the clinical effectiveness of potential treatment strategies for COVID-19, which cannot be addressed with clinical trials alone.

However, for the evidence generated from observational studies to be decision grade, the studies must be well designed and pertain to large patient populations; this requires transparency in protocol methods and collaboration to improve study sizes.

Therefore, the EMA has urged researchers to adhere to existing guidelines concerning the appropriate design and conduct of observation, real-world data studies – including the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance’s (ENCePP®) Guide on Methodological Standards in Pharmacoepidemiology – and for investigators to upload all protocols and reports of observational COVID-19 studies in The European Union electronic Register of Post-Authorisation Studies Register (EU PAS Register).

These actions are important for the generation of reliable, reproduceable evidence and for ensuring investigation transparency for scrutiny of design and results.

The EMA and ENCePP have also set up a COVID-19 response group, to help support collaboration and the conduct of high-quality observational research during COVID-19 and maximize the contribution of these studies to understanding of medicines’ use during this time.


Sources:

www.ema.europa.eu/en/news/ema-calls-high-quality-observational-research-context-covid-19; www.ema.europa.eu/en/news/global-regulators-commit-cooperate-observational-research-context-covid-19

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