This white paper offers practical strategies on how sponsors can handle compliance in light of the recent ICH E6(R3) update.
By Francine Lane
With the adoption of the International Council for Harmonisation guideline, ICH E6(R3), in January 2025, plain language summaries have moved from nice-to-have to regulatory expectation. For the first time, Good Clinical Practice GCP) guidelines explicitly require sponsors to provide trial results to participants “in language that is non-technical, understandable to a layperson, and non-promotional" when summary results are shared with participants. Yet despite this clear mandate, many organizations are struggling with practical implementation challenges that go far beyond simply writing better summaries.
If your organization is grappling with how to scale plain language disclosure across your portfolio while managing legal concerns, site engagement issues, and cross-departmental coordination, you're not alone. Here's what we're hearing from sponsors and practical strategies to move forward.
The Challenge Landscape: What Sponsors Are Really Facing
Legal and regulatory hesitation
Despite no regulation explicitly prohibiting public posting of plain language summaries, legal teams remain cautious. The most common concern? "We're not required to do this, so why take the risk?" This hesitation often stems from uncertainty about promotional guidelines and liability considerations rather than actual regulatory barriers.
The reality check: You're already posting results on ClinicalTrials.gov and other registries. Plain language summaries simply translate that same information into accessible language using the same factual content but presented in terms patients and caregivers can understand. This represents translation risk, not new disclosure risk.
Informed consent complications
Academic sponsors and smaller biotechs frequently worry about sharing results when plain language summaries were not explicitly mentioned in original informed consent forms. This creates a perceived barrier to posting summaries for completed studies.
The practical solution: For legacy studies, passive posting of summaries (making them publicly available where patients can find them) is generally acceptable. Platforms that allow early study posting enable sites to share study links during enrollment, allowing participants to subscribe to notifications when results become available — addressing both consent transparency and participant engagement.
For future studies, include specific language in informed consent forms about plain language summary availability and how participants can access results. Sample language might include: “When study results become available, we will make a plain language summary accessible to you that explains the findings in nontechnical terms. You can find information about accessing these results at [study-specific link or general platform reference].”
Site engagement reality
Perhaps the biggest implementation challenge isn't regulatory — it's operational. Clinical sites consistently deprioritize transparency activities. As one sponsor shared, "We care about transparency, but in the reality of the big picture, sites don't. It's really hard to make that change."
This creates a fundamental disconnect between sponsor intentions and patient access to information. Even when sponsors develop excellent plain language summaries, they often never reach the participants they're intended to serve. However, platforms that allow early study posting with participant notification sign-up can shift this burden from sites to participants themselves, enabling direct engagement from study enrollment through results publication.
Cross-departmental communication gaps
Even when legal and consent hurdles are addressed, internal misalignment can stall progress. The new GCP compliance requirements may be falling through organizational cracks. Clinical operations teams focused on GCP compliance may assume disclosure teams are handling results sharing, while disclosure teams may not be aware of the new requirements. This communication gap means some organizations aren't leveraging the strong regulatory foundation that now supports transparency initiatives, missing opportunities to build compelling internal business cases.
