Understanding Open Access Policies in Clinical Trial Publishing

Introduction: The Rise of Open Access in Clinical Research

Open access (OA) publishing is transforming the way clinical trial results are shared with the global scientific community and the public. Traditionally, medical journals operated on subscription-based models, limiting the visibility of research. Today, funders, regulators, and journals are driving an unprecedented shift toward open access—making clinical trial data more accessible, transparent, and reusable.

Open access is not just about free reading. It involves rights for reuse, public archiving, and in many cases, funder compliance. In this article, we’ll explore the major open access models, policies of leading medical journals, and implications for trial sponsors and investigators aiming for transparent publication of their clinical data.

Types of Open Access: Gold, Green, and Hybrid

There are three core models of open access relevant to trial publications:

• Gold OA: Articles are made immediately available by the publisher under an open license (e.g., Creative Commons). Authors or sponsors usually pay an Article Processing Charge (APC).
• Green OA: Authors self-archive a preprint or postprint version in an institutional or subject repository (e.g., Europe PMC), typically after an embargo period.
• Hybrid OA: Subscription-based journals offer individual OA options for an APC while keeping other content behind paywalls.

Understanding these models helps researchers select suitable journals that align with sponsor or regulatory OA requirements, such as the European Union’s Horizon 2020/Europe mandate or NIH’s Public Access Policy.

OA Policies of Leading Medical Journals

Each major medical journal or publisher has its own open access policy. Here is a comparative overview of key players:

Before submission, authors should review individual journal policies, which are often detailed under “Instructions for Authors” or “Open Access” sections.

Funder and Institutional OA Requirements

Funding agencies increasingly mandate open access to published trial results. Notable examples include:

• NIH (USA): Requires deposition in PubMed Central within 12 months.
• Horizon Europe: Immediate gold OA with CC BY licensing required.
• Wellcome Trust: Supports full gold OA with APC coverage.
• Bill & Melinda Gates Foundation: Mandates immediate OA via PubMed Central or equivalent.
• WHO: Strongly encourages OA publication for all WHO-funded trials.

Non-compliance can affect future funding eligibility or trigger audits. Clinical teams should plan publication strategies in alignment with funder policies during trial planning stages.

Plan S and Its Impact on Trial Publishing

Plan S is an international OA initiative requiring all scholarly publications funded by cOAlition S members to be published in compliant open access journals or platforms. It affects trial sponsors in the EU, UKRI (UK), and some global health agencies.

Plan S compliance requires:

• Immediate availability (no embargo)
• Publishing under a CC BY license
• Disclosure of all fees (transparency in APCs)

Many major journals now offer Plan S-compliant routes, but authors must verify compliance before submission.

Managing APCs and Sponsor Budgeting

Article Processing Charges (APCs) can be significant—ranging from $1,500 to over $10,000 depending on the journal. Trial sponsors should:

• Include APCs in trial budgets from the outset
• Negotiate institutional discounts or use transformative agreements
• Prioritize journals with tiered pricing for LMIC authors if applicable

Some publishers (e.g., Springer Nature, Elsevier) have national-level deals that waive or reduce APCs for researchers in certain countries or institutions.

Transparency Beyond Access: Data and Protocols

Modern OA policies increasingly extend beyond the article to include:

• Trial Protocols: Published as supplementary material or in protocol journals (e.g., BMJ Open)
• Datasets: Linked to repositories like Dryad, Figshare, or institutional databases
• Analysis Code: Shared via GitHub or repositories with DOIs

This reinforces reproducibility and is encouraged under ICMJE and SPIRIT guidelines. Some journals require a Data Availability Statement or Data Sharing Statement per ICMJE.

Choosing the Right Journal: Key Considerations

Before submission, evaluate journals using the following criteria:

• OA policy and licensing terms
• Indexing in PubMed, DOAJ, Scopus, etc.
• Impact Factor and readership relevance
• Funder compliance (Plan S, NIH, Gates)
• Costs and APC waivers

Resources like the Journal Checker Tool help match journals with funder mandates and OA routes.

Conclusion: Open Access is Now a Regulatory and Ethical Norm

The shift to open access in clinical trial publishing is not just a publishing trend—it’s a compliance imperative. Sponsors and investigators must now navigate funder rules, licensing standards, APC costs, and journal requirements to ensure that trial results reach the public without barriers.

By planning early, selecting journals strategically, and aligning with global transparency norms, research teams can meet ethical obligations, enhance visibility, and ensure continued eligibility for funding and regulatory goodwill.