Observational studies must be reformed before the next pandemic - Nature Medicine

Conducting observational studies across settings via a network unified in protocol and data standards would provide high-quality evidence to policymakers and prevent the controversy associated with multiple low-quality studies providing conflicting information.

Reformed observational studies should, when published, be accompanied by appropriate explanatory text to guide their interpretation, such as the"Key Findings” section provided by some journals at the beginning of articles to provide context. Including an equally prominent, plain-language interpretation of the statistical claims and limitations of observational studies could mitigate the risk of intentional or unintentional misinterpretation.

The informed consent process for observational studies is frequently less robust than that for interventional studies, creating a barrier to understanding the true meaning and extent of data sharing. Even if participants are not ultimately harmed by this practice, a lack of informed discussion before data collection can undermine public trust in health research.

Finally, lowering barriers to implementation through free access to training materials, open standards and data to facilitate research would provide an incentive to form an observational study user community. Designing new standards for observational studies and training researchers to adopt them as a part of routine scientific inquiry would also develop capacity for producing high-quality results during the next crisis.

At the regulatory level, standardizing ethical and scientific review of master protocols and data standards within and between countries would allow simultaneous collection of high-quality observational data for public health response and research use, rather than the conduct of research using data and samples collected solely for response purposes without the use of rigorous epidemiologic methods.

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