How Journals and Sponsors Shape Open Access in Clinical Trial Publication

Introduction: Why Open Access is Now Non-Negotiable

Open access (OA) has moved from being an academic preference to a clinical trial mandate. Regulatory agencies, funding bodies, and public advocacy groups are demanding increased transparency and wider availability of trial data. At the center of this movement are journal publishers and study sponsors, whose open access policies shape how, when, and where clinical trial results are published and accessed.

This article dives into the policies enforced by top medical journals and sponsors, the legal and ethical mandates around data dissemination, and the strategic decisions pharma professionals must make to stay compliant with evolving expectations.

Types of Open Access Models Explained

Before exploring specific policies, it’s crucial to understand the main OA models that journals and sponsors support:

• Gold Open Access: Articles are immediately free upon publication. Often involves an Article Processing Charge (APC).
• Green Open Access: Authors self-archive a version (pre-print or post-print) in a public repository after an embargo period.
• Hybrid Access: Subscription journals offer optional open access for individual articles upon payment of APC.
• Bronze Access: Articles are free to read but lack a clear reuse license.

Most clinical trial sponsors favor Gold or Green models to ensure compliance with funder mandates and transparency guidelines.

Major Sponsor Requirements for Open Access

Pharmaceutical sponsors and public agencies have begun enforcing open access publication as a formal requirement. Below is a snapshot of leading mandates:

Open Access Mandates from Major Journals

Leading medical journals have differing OA policies that authors must navigate:

• The BMJ: Full Gold OA journal. Mandates CC-BY license for research articles.
• NEJM: Subscription-based with optional OA for selected articles (high APC).
• The Lancet: Hybrid model. OA allowed with Plan S-aligned license and payment.
• JAMA: Permits Green OA after embargo. Offers OA for funder-mandated papers.
• PLOS ONE: Gold OA journal. No subscription content. APC applies to all.

Authors publishing trial results must align journal selection with sponsor obligations and transparency goals.

Plan S and the Rise of Funder-Led Publishing Requirements

Plan S is a coalition of funders including the European Commission, Wellcome Trust, and others requiring that all research they fund be published in compliant OA journals or platforms. Requirements include:

• Immediate open access without embargo
• Use of Creative Commons Attribution License (CC BY)
• Deposition in approved repositories
• Transparency in APC pricing

For clinical trial teams working under these funders, failing to publish in a compliant venue may jeopardize future funding.

Case Example: NIH-Funded Oncology Trial

A multicenter oncology trial funded by the NIH completed in 2022. As per NIH’s Public Access Policy, the manuscript was submitted to a hybrid journal that did not offer immediate open access. The team faced the following challenges:

• Delayed deposit of the accepted manuscript in PubMed Central
• Need to revise the publishing agreement to enable Green OA
• Inclusion of proper grant acknowledgment and NIH grant number

Ultimately, compliance was achieved after coordination with the publisher and NIH Manuscript Submission system (NIHMS).

Embargo Periods: How Long Can Access Be Delayed?

Embargoes refer to the time between article publication and when it becomes freely accessible in a public repository. Funders and journals vary:

• NIH: 12 months maximum
• Wellcome: No embargo allowed
• EC Horizon: Immediate access required
• NEJM: 6 months common unless OA option selected

Trial sponsors must integrate embargo planning into their publication strategy to avoid non-compliance.

Journals vs Repositories: Parallel Dissemination Strategy

Most funders allow dual routes of dissemination:

1. Journal Publication: Peer-reviewed, formal publication
2. Repository Submission: Depositing accepted manuscript in platforms like PubMed Central, Europe PMC, or institutional repositories

For example, a trial published in JAMA may have its accepted version archived in Europe PMC under funder guidelines. Both routes contribute to visibility and access.

Publication SOPs for Sponsors

Pharma companies and CROs must maintain internal SOPs that align with global OA mandates. These SOPs often include:

• Pre-submission compliance checks
• Preferred journal list with OA compatibility
• Coordination with medical writers and authors
• Archiving requirements in corporate repositories
• Communication with funders on embargo negotiations

Failure to follow these SOPs can result in inspection findings under GPP3 (Good Publication Practice) guidelines.

Best Practices for Trial Teams

• Check funder OA mandates before selecting a journal
• Choose journals indexed in trial registries or connected to ORCID/iCite
• Budget for APCs in grant or sponsor funding plans
• Document all communications with publishers regarding access rights
• Use institutional OA advisors to resolve legal conflicts

Planning ahead minimizes the risk of non-compliance and improves the trial’s dissemination timeline.

Conclusion: Ensuring Access to Scientific Knowledge

Open access policies are no longer optional — they are legally and ethically mandated across the global clinical trial landscape. Journals and sponsors play pivotal roles in ensuring trial outcomes are not locked behind paywalls. By understanding the varying models, planning for APCs, and aligning with sponsor and funder expectations, clinical research teams can ensure that trial results reach the widest possible audience — fostering public trust, advancing science, and meeting transparency goals.