This white paper offers practical strategies on how sponsors can handle compliance in light of the recent ICH E6(R3) update.
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.
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.
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].”
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.
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.
The new ICH E6(R3) compliance requirements, combined with the updated Declaration of Helsinki (2024 revision) ethical standards, provide compelling backing for plain language initiatives. Use this regulatory foundation to build your business case with senior management. The question has shifted from “Why should we do this?” to “How do we implement this requirement effectively?”
Neither sponsor websites nor regional registries fully solve the access problem: company sites are fragmented, and registries remain limited to specific geographies. The only global, sponsor-agnostic solution available today is TrialSummaries.com, which addresses key implementation barriers by:
Rather than implementing study-by-study, build systematic processes that work across your entire portfolio. This includes:
For senior leadership, the case for plain language summaries includes these five priorities:
Implementation success comes from addressing real operational challenges rather than just policy decisions. The most effective organizations start with pilot programs to test their processes, then build cross-departmental workflows that sustain transparency beyond individual studies.
Today, more than 23 sponsors are already participating in TrialSummaries.com, leveraging shared infrastructure to scale efficiently. These companies aren’t necessarily the largest or most resourced — they are the ones that have systematically addressed challenges and taken advantage of proven platforms to reduce duplication, manage risk, and reach patients globally.
Your organization likely has most of the pieces needed for success. The key is connecting them into sustainable, patient-centered processes that fit your operational realities.
Ready to explore how your organization can implement scalable plain language summary processes? We’d welcome the opportunity to share specific insights from successful implementations across 23+ sponsor organizations and how their approaches might address your operational challenges. Let’s continue the conversation about building transparency solutions that not only work for your organization but also honor the time and trust of the patients who participated in your research.
Francine Lane
Head of Transparency
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Head of Transparency
Citeline
Francine Lane is Head of Transparency at Citeline and former chair of the Drug Information Association (DIA) Clinical Trial Disclosure Community. Francine is responsible for helping TrialScope Disclose and TrialSummaries.com customers meet and exceed current disclosure expectations globally, giving them the tools they need to satisfy the requirements in this evolving industry. Francine also dedicates her time building relationships with external stakeholders — including sponsors, investigators, regulators, and transparency and patient advocates — to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet transparency expectation and requirements.
