Open access to clinical trial results: a public health imperative?

Picture of Maurice Bagot D'arc

Maurice Bagot D'arc

ENT surgeon, head and neck surgeon, specialized in ENT oncology, legal compensation for bodily injury, and pharmaceutical marketing, with over 30 years of experience in Medical Affairs serving the healthcare industries and 15 years of surgical practice.

Open access to clinical trial results in France has been monitored since 2018 through the French Open Science Barometer. Initially focused on peer-reviewed publications, the barometer has expanded to include clinical research, assessing the transparency of clinical trial results and observational studies.

The 2025 edition of the barometer revealed a concerning trend: nearly one in two clinical trials conducted in France between 2013 and 2023 were never made publicly available. These results were absent from both regulatory registries (such as EudraCT or ClinicalTrials.gov) and from scientific journals. The situation is even more critical in the public sector, where 78% of trials completed in 2021 remained unpublished, compared to 30% in the private sector. This lack of publication is not simply an oversight.

It represents a violation of legal obligations, particularly under Regulation (EU) No. 536/2014, and undermines scientific transparency. Unpublished data weakens the quality of meta-analyses, increases publication bias, and creates gaps in the databases used to inform clinical and public health decisions.

Promoting open access to clinical trial results: more than a formality, a responsibility

Publishing clinical trial results—whether positive or negative—is a core element of biomedical research. It ensures that the knowledge generated is preserved, shared, and used to benefit the scientific community and ultimately, patients.

However, the path to publication remains complex for many sponsors, whether academic institutions or private companies:

  • Journal selection is difficult: impact, speed, and audience must all be balanced
  • Regulatory constraints: in the EU, results must be submitted within 12 months after trial completion via the CTIS system
  • Open access publication costs can be prohibitive for public institutions
  • Editorial processes are rigorous and can discourage early-career researchers

Scientific transparency as a strategic asset

Despite these challenges, some organizations are stepping up. BluePharm, a company specializing in clinical development support, is committed to helping trial sponsors maximize the value of their research.

Its approach is built around three pillars:

  • Editorial planning starting from the trial design phase
  • Regulatory compliance, in close collaboration with European health authorities
  • Targeted visibility, including support in selecting appropriate journals (open access, indexed, fast turnaround)

The goal is simple: avoid letting valuable results go unseen after years of research and patient involvement.

Good practices to adopt

To prevent your trial data from being forgotten, here are some simple, actionable recommendations:

  1. Register the clinical trial before recruitment starts (on ClinicalTrials.gov, EudraCT, etc.)
  2. Plan for publication early, with a clear editorial strategy
  3. Include and contextualize negative or inconclusive results
  4. Prioritize open access journals supported by public funding programs
  5. Share raw data according to the FAIR principles (Findable, Accessible, Interoperable, Reusable)

Conclusion

As open science becomes a standard expectation, publishing clinical trial results can no longer be seen as optional. It is a scientific, ethical, and legal obligation. Publishing is also key to building trust among researchers, institutions, and the public. France, despite its strong track record in clinical research, must improve the traceability and accessibility of trial data to stay globally competitive. That effort begins with rigorous, open publication.

further reading

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