Publishing Clinical Trial Results: A Regulatory Obstacle or Strategic Opportunity?

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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.

Publishing Clinical Trial Results is a pivotal step in the development of a drug or medical device. More than a scientific formality, it is a strategic move that amplifies research impact, supports regulatory pathways, and fulfils both ethical and transparency obligations. Whether from academic or industry sponsors, a well-planned publication strategy can make the difference between a lost opportunity and long-term visibility.

In this article, BluePharm, a trusted partner in regulatory and clinical development across Europe, outlines the key factors to consider when choosing a scientific journal to publish your trial data.

Publishing Clinical Trial Results: a strategic decision

Selecting the right journal should not be treated as a routine choice. It determines how your results are perceived, cited, and even used in regulatory assessments. A well-targeted publication enhances your credibility among peers, regulatory bodies, and payers.

In many cases, publication influences downstream processes such as marketing authorization (MA) or reimbursement decisions, making it a powerful lever in a product’s lifecycle.

1. Define your scope and audience

Before choosing a journal, it’s crucial to clarify the nature and objective of your trial:

  • What type of trial is it? (early-phase, pivotal, post-marketing)
  • What’s the main outcome? (efficacy, safety, biomarkers, QoL, etc.)
  • Who is the audience? (clinicians, researchers, regulators, investors, payers)

For instance, a Phase I safety study might suit a pharmacology journal, whereas a Phase III randomized controlled trial would better fit a high-impact, general medical journal like The Lancet or NEJM.

2. Impact factor matters—but isn’t everything

The Impact Factor remains a widely used metric, reflecting how often articles from a journal are cited. However, niche journals like Clinical Trials or Journal of Clinical Oncology may offer more targeted visibility within specialist communities.

Also consider other metrics: H5 index, indexing on PubMed Central, turnaround time, and discoverability via platforms like Google Scholar.

3. Open Access or subscription-based?

Open Access (OA) journals allow free and immediate access to published results. This aligns with EU Regulation 536/2014, which mandates greater transparency in clinical trial data. Journals like BMJ Open or PLOS ONE are increasingly favoured for their fast publication cycles and wide readership—although they may require article processing charges (APCs).

At BluePharm, we observe that Open Access often benefits sponsors aiming to attract investors, boost engagement with institutions, or highlight scientific value for early-stage innovations.

4. Editorial transparency and turnaround time

Not all journals follow equally rigorous editorial processes. Look into:

  • Rejection rates
  • Average time to decision
  • Peer review transparency

Tools like Scimago Journal Rank, JournalGuide, or Think.Check.Submit help you assess the reliability of a journal and avoid predatory publications—still too common in the biomedical space.

5. Align with EU regulatory requirements

Under EU Clinical Trial Regulation 536/2014, timely publication is not optional—it’s a legal and ethical obligation. All results must be submitted to the CTIS portal within 12 months of trial completion. Choosing a journal with a rapid review process—and one that accepts negative or inconclusive results—is essential for regulatory compliance.

6. Embrace transparency and data sharing

More journals now demand trial pre-registration (e.g., on ClinicalTrials.gov or EudraCT) and encourage raw data sharing. This aligns with ICH-GCP standards and reflects a broader shift toward openness in science. At BluePharm, we actively support such practices as part of responsible research dissemination.


    Conclusion

    Publishing a clinical trial is more than a checkbox—it’s a strategic pillar of medical innovation. It requires balancing scientific impact, visibility, compliance, and ethical accountability. Whether you’re an academic investigator or an industry sponsor, thoughtful planning can ensure your results get the attention—and regulatory weight—they deserve. BluePharm can support you in this important step of your development.

    Publishing Clinical Trial Results

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