Building trust through transparency: updates to the Journal of Comparative Effectiveness Research author guidelines for real-world evidence studies

There is no doubt that real-world evidence (RWE) is becoming a cornerstone of modern healthcare decision-making. From regulatory approvals to policy development and clinical practice, RWE studies are shaping critical choices about patient care. Yet as their influence grows, so too does scrutiny over the credibility and reproducibility of these studies, which historically have not been considered as robust as the perceived gold standard of randomized controlled clinical trials.

At the Journal of Comparative Effectiveness Research (JCER), we recognize that transparency is essential to meeting this challenge. That is why we have updated our author guidelines to encourage submissions reporting RWE studies to include a data transparency statement. This statement should summarize the availability of study protocols, preregistration details, data access procedures, analytical code, and reporting checklists – key elements recommended by Wang and Pottegård in their transparency framework for RWE.

Raising the bar for RWE studies

Publication in a peer-reviewed journal remains one of the strongest signals of study quality. Yet high-profile retractions of RWE studies during the COVID-19 pandemic served as a sobering reminder: peer review alone cannot always prevent the publication of inaccurate research. This is not unique to RWE studies, but the field’s reliance on heterogeneous, complex real-world data (RWD) amplifies these risks.

As Richard White has argued:

“It is now the responsibility of researchers (whether in academia or industry) and their collaborators… to follow these recommendations, and for journal editors and peer reviewers to mandate the required quality standards in publications of RWE studies.”

Wang and Pottegård echo this perspective, emphasizing the pivotal influence journals can have on research practices:

“Scientific journals play a central role. If they require more transparent reporting (e.g., by requiring authors to include such a transparency statement) it will over time make transparency part of study planning and conduct.”

In line with other journals in our field and with organizations such as the International Society for Pharmacoepidemiology (ISPE) and ISPOR – The Professional Society for Health Economics and Outcomes Research, we at JCER view this as a collective responsibility. By setting higher expectations for transparency in RWE publications, we aim to strengthen the scientific record and ensure evidence is robust and fit for decision-making.

A response to a changing landscape

This update also reflects a wider reality: public trust in research is under pressure and research integrity issues are an ongoing challenge. In a world where misinformation spreads rapidly – amplified by AI – simply doing rigorous work is no longer enough. We must demonstrate it, clearly and consistently.

Journals have always been guardians of ethical and transparent scholarly publishing. Championing these expectations for RWE studies is both a natural progression and an urgent necessity.

Transparency statements not only support peer reviewers and readers but also align with the broader movement towards open science. They can help normalize practices, like preregistration and code sharing, that strengthen confidence in RWE.

Looking forward

At JCER, we recognize that embedding transparency and reproducibility in routine research conduct is a shared journey. Researchers, industry collaborators, journal editors and peer reviewers all have a role to play in raising standards. Publishing practices are continually evolving, and our updated author guidelines are one step in that journey.

By encouraging clear, honest and consistent reporting, we hope to contribute to an RWE landscape where high-quality studies are the norm and where trust in RWD and its applications is not just maintained but reinforced.

We invite our authors and readers to join us in this effort to advance open, rigorous and decision-ready science. To submit to JCER, please review our Journal Information.