GCP in 2025: A Transparency Revolution

What the GCP Guidance updates mean for disclosure, plain language, and participant trust

By Francine Lane

The adoption of updates to the updated Good Clinical Practice guideline, ICH E6(R3), from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), represents the most significant expansion of transparency requirements in clinical research in years. The update elevates transparency from a regulatory checkbox to a core ethical principle — placing participant communication and public disclosure at the heart of modern trial conduct.

Key impacts for clinical trial sponsors:

1. Transparency as a GCP principle: Disclosure of results is now a fundamental ethical requirement — not just a regional compliance obligation. This includes most Phase I trials that may have previously been excluded from regulatory requirements.
2. Plain-language mandate: Participants who receive results should have them in accessible, nontechnical language.
3. Treatment disclosure pathway: Sponsors must establish clear processes for informing participants and investigators about treatment assignments after unblinding.
4. Scalable disclosure and dissemination: Meeting global requirements will require updated processes and technologies to manage language versions, track communications, and ensure broad accessibility.

Organizations already committed to transparency may be well-positioned. But for others, ICH E6(R3) creates an urgent need to enhance disclosure policies, strengthen internal capabilities, and invest in systems that support efficient, compliant, and participant-centered communication.

Transparency elevated to a core principle

For the first time in GCP history, transparency is explicitly established as a fundamental principle. Principle 9.6 of the ICH E6(R3) states:

“The transparency of clinical trials includes timely registration on publicly accessible and recognised databases and the public posting of clinical trial results. Communicating trial results to participants should be considered. Such communication should be objective and non-promotional.”

This represents a major shift in expectations. Transparency is no longer limited to select registries or summary postings. Sponsors must think holistically about how they share trial results with both the public and participants:

• Posting trial results publicly is now a baseline requirement for studies conducted under GCP, including Phase I or early phase trials.
• Publication strategies must be documented in the protocol or in a separate agreement.
• Participant-focused communication is no longer optional — it’s an expected practice.

For organizations, this creates a need for tighter integration among clinical operations, disclosure, medical writing, regulatory, and patient engagement teams.

Plain language summaries as a global expectation

ICH E6(R3) introduces new specificity about the language and format of participant communications. Section 3.17.2(c) requires sponsors to provide investigators with trial results, and specifies that results summaries for participants must be:

“… non-technical, understandable to a layperson, and non-promotional.”

Section 2.9.3 adds that investigators should:

“… inform the participant about the trial results and treatment received … with due respect to the participant’s preference to be informed.”

This reinforces plain language summaries (PLS) as a global expectation. To meet this, sponsors will need to:

• Build or access specialized writing capabilities to create accessible and accurate content.
• Review summaries for both scientific fidelity and readability, adapting review workflows as needed.
• Consider cultural and linguistic context, including local health literacy, when creating and translating summaries.

Disclosure and dissemination: the operational challenge

While the ethical case for transparency is clear, implementation is not without challenges. Disseminating summaries and managing global disclosure processes introduce new complexity:

• Volume and complexity: Sponsors may be managing dozens of summaries per year, in multiple languages, across regions with varying expectations.
• Translation and localization: Language access is essential but costly and time-consuming without the right systems.
• Participant access: Participants may need to be reached months or even years after study completion — requiring reliable systems to track who received what, when, and in which format.
• Auditability and compliance: Disclosure and participant communication must be both verifiable and aligned with documented policies.

Technology will be an important enabler. Scalable platforms that support disclosure tracking, plain-language content management, and participant communication can help reduce operational burden while improving equity and access. These systems should also account for future regulatory harmonization and evolving expectations from ethics committees, regulators, and the public.

Implementation priorities for sponsors

To meet ICH E6(R3) expectations — and to lead in ethical trial conduct — organizations should prioritize:

• Policy modernization: Update internal disclosure and transparency policies in line with ICH E6(R3).
• Capability building: Train or hire experts in plain-language communication and disclosure strategy.
• Cross-functional collaboration: Ensure alignment across clinical operations, regulatory, disclosure, and patient engagement teams.
• Technology evaluation: Assess whether existing systems can support modern disclosure and dissemination requirements — or whether purpose-built tools are needed.
• Process integration: Embed summary development, review, and dissemination into study closeout workflows.

Building trust through transparency

ICH E6(R3) signals a shift in how the clinical research community is expected to treat transparency — not just as a box to check, but as a core value. Participants are no longer seen as data sources alone. They are contributors who deserve to understand the outcomes of the studies they make possible.

This presents a real opportunity. Organizations that invest in meaningful disclosure — supported by sound policies, clear communication, and thoughtful infrastructure — will not only meet compliance expectations, but also demonstrate leadership in integrity, respect, and participant engagement.