How Plain Language Summaries Created Under EU CTR Can Help Shape NIH Policy

By Kimbra Edwards, Senior Director, Health Communication Services, CISCRP, and Malgorzata Sztolsztener, Director, Patient Communication, AstraZeneca

Only 18% of people have “a lot” of trust in pharmaceutical companies, according to a recent CISCRP global survey of 12,887 individuals. While trust among government research organizations is notably higher (43%), there is still room for improvement, especially within the U.S. as only 32% of U.S. survey respondents reported having a lot of trust in their government research organizations, such as the NIH.¹ By contrast, 61% of European survey respondents reported having a lot of trust in their government research organizations.

Building this trust is essential for the clinical research industry, and one way to do that is with plain language summaries. Sharing the results of a research study to participants in plain language demonstrates respect, gratitude, and transparency, and ultimately helps build trust among researchers and patients and the public.

Where The EU, UK, And U.S. Stand With PLS

As of January 2022, the European Union Clinical Trials Regulation (EU CTR 536/2014) requires sponsors to submit a plain language summary of trial results (PLS) to the clinical trial information system (CTIS) within 12 months of trial completion (six months for pediatric trials). The PLS must include the trial’s purpose, participant population, overall results, adverse reactions (possibly related adverse events), and overall conclusions presented in language appropriate for a general audience.² While the EU is a clear trailblazer in the PLS space, the UK has also implemented a somewhat similar PLS policy as of April 2026.

The Good Lay Summary Practice (GLSP) guidance provides recommendations and best practices for creating, translating, and disseminating patient-friendly PLS to meet EU CTR requirements.³ developed through a multi-stakeholder collaboration and adopted by the Clinical Trial Expert Group (a working group of the European Commission representing Ethics Committees and National Competent Authorities), the GLSP is a key reference for implementation of the EU CTR PLS requirements and a widely recognized industry standard. It’s especially valuable because the EU CTR provides only broad requirements for PLS, leaving limited detailed direction on exactly how to create and what to include in a successful PLS.

In March 2026, the NIH announced a two-part policy development process that would require the return of PLS to participants in all NIH-funded clinical research. Part 1, occurring Spring 2026 to early 2027, focuses on developing requirements for sharing summary-level study results in clear, understandable language, while Part 2 will address the return of individual participant-level results. Importantly, with this policy the NIH is addressing participants’ desire for plain language aggregate trial results and individual results. CISCRP’s 2025 Perceptions & Insights Study shows that respondents are most interested (81%) in receiving their individual study results after participation in a clinical research study, followed closely (78%) by a summary of the study results¹. These findings have remained consistent over the past ten years.

Long-Time Efforts Coming To Fruition With NIH PLS Policy

It is encouraging to see the NIH begin development of this PLS policy, reflecting a growing global recognition of the importance of transparency, participant engagement, and accessible communication of clinical research results. A draft policy for Part 1, released for public comment on August 27, 2026, contains high-level requirements alongside a request for information for supplemental guidance on participant preferences/experiences, best practices for researchers, and implementation needs. We are optimistic that the NIH will look to existing policies and guidelines, such as the GLSP, as well as stakeholders with extensive PLS experience, to both inform and strengthen their policy and guidance.

AstraZeneca and CISCRP have spent over a decade collaborating on PLS, establishing effective and compliant processes that support regulatory compliance. The NIH policy scope is likely to extend across a broader range of research settings than the EU CTR, including observational studies, registries, biobanks, long-term cohorts, and secondary use of data or biospecimens. This creates an important policy-design challenge: how to establish consistent principles for returning summary-level results while allowing implementation approaches to vary depending on the research model. With this broader context in mind, many of the foundational principles, operational considerations, and communication best practices developed through EU CTR experience remain transferable and can support NIH policy development as well as those who will be newly tasked with creating PLS. Below, we outline some of the key lessons learned to support NIH policy development as well as those who will be newly tasked with creating PLS.

Insights To Support NIH Policy Requirement ambiguity creates implementation challenges

The EU CTR established an important framework, but some requirements lack sufficient specificity to support consistent implementation. In particular, the regulation provides limited guidance on how to present overall results and safety findings, resulting in differing approaches across sponsors.

The EU CTR requires sponsors to provide the “overall results of the clinical trial”, and states that this should include, at a minimum, the results of the primary endpoints and potentially patient-relevant secondary endpoints. The GLSP notes that because there is no universal definition of “patient-relevant” endpoint, sponsors may want to consider limiting the PLS results section to only include primary endpoints. This straightforward approach taken by many research sponsors minimizes the risk of cherry-picking secondary endpoints and producing a potentially promotional PLS. Another approach sponsors have adopted is to create a portfolio-wide policy that keeps secondary endpoint inclusion consistent across all PLS, regardless of the outcome of the endpoint. For example, PLS can include secondary endpoints only if they are PROs or overall survival, as these are likely highly patient-relevant. With enough planning, sponsors could also decide which secondary endpoints to include in the PLS after the protocol is finalized and before the study is conducted. Ideally, patients would provide input help identify the most meaningful secondary endpoints.

With regards to safety findings, the EU CTR requires sponsors to include a “description of adverse reactions and their frequency,” where adverse reactions are defined as an adverse event in which there is a “reasonable possibility of establishing a causal relationship between the event and the investigational medicinal product based on an analysis of available evidence” (EU CTR Annex III 2.1.3). The EU CTR provides little direction on what this should entail in practice, particularly for studies with complex designs, multiple treatment arms, or certain indications with complex safety profiles. For example, it does not specify whether sponsors should report all adverse reactions, leaving sponsors to adopt varying approaches to balance completeness and readability while still ensuring the information remains meaningful. The GLSP does recommend use of a “reasonable and clearly communicated cut-off when needed” and that this cut-off is likely to vary depending on a variety of factors. In practice, many sponsors align cut-offs with those used in the clinical study report.

NIH guidance should also address the need to communicate negative, inconclusive, conflicting, or early-terminated study results, as these scenarios are especially vulnerable to inconsistent interpretation and may require careful explanation to remain transparent without overstating conclusions. Sponsors should create PLSs irrespective of study outcome, consistent with the EU CTR approach and the broader spirit of transparency in clinical research. This is particularly important because participants should understand not only positive findings, but also when a study did not answer the research question, was stopped early, or produced results that require cautious interpretation.

Without clear implementation guidance, sponsors are left to develop their own internal standards, leading to variability in PLS content and presentation. This variability creates a risk that the results of some trials may misleadingly appear more favorable than others, potentially influencing the readers’ perception of safety and efficacy. To promote greater consistency while still allowing for necessary flexibility, the NIH should consider including guidelines that outline minimum content expectations and provide practical examples for common study scenarios.

Protecting participant privacy requires a thoughtful approach

Protecting participant privacy is a fundamental consideration when creating PLS. While transparency is an obvious goal of PLS, they should balance meaningful disclosure with safeguarded participant confidentiality. The EU CTR provides limited guidance on how to strike this balance, leaving sponsors to make case-by-case decisions when determining the appropriate level of detail to include, particularly for smaller studies that enroll fewer participants or those for rare diseases.

Like the EU CTR, the GLSP emphasizes that PLS should only present aggregate data and avoid including any information that could identify an individual participant. However, it provides limited practical guidance for how to handle specific scenarios where participant confidentiality may still be at risk despite only presenting aggregate data. In the absence of more specific guidance, sponsors have been responsible for determining how best to balance participant privacy and data transparency while also ensuring compliance with applicable legal data protection requirements. In such scenarios, some sponsors have elected to omit participant demographic information (age, race/ethnicity, or location) as well as detailed efficacy or safety results, instead providing only a high-level statement.

Variability in how sponsors approach protecting participant privacy creates risks at both ends of the spectrum: providing too much detail may increase the potential for participant re-identification and undermine participant trust, while providing too little information may reduce usefulness of the summary and give the impression that important results are being withheld. It would be beneficial for the NIH to provide clear expectations, practical guidance, and specific examples for common scenarios in which privacy concerns require careful consideration.

Plain language does not guarantee understandability

Developing a PLS that is both accurate and meaningful requires more than just writing technical language into plain language. Complex concepts such as uncertainty, statistical significance, and risk often must be addressed in PLS in a manner that is understandable and accurate without appearing misleading or condescending. Ineffective communication may lead to the spread of misinformation and loss of patient and public trust.

Effective PLS development should consider both content and design. Even well-written plain language text may be difficult to understand if it is presented in a dense or overly technical format. Visual design elements, such as tables, simple graphics, call-out boxes, summaries of key messages, and clear section headings, can support comprehension by helping readers process numerical data, safety information, uncertainty, and complex scientific concepts.

There are several great resources currently available to aid PLS writers, such as the GLSP and the MRCT plain language clinical research glossary.⁴ The NIH should make recommendations aligned with these resources or at least provide a comprehensive list of existing resources. While readability formulas, such as SMOG and Flesch-Kincaid can be helpful tools for an initial assessment, they do not guarantee actual PLS understandability. PLS drafts should be reviewed by representatives of the target readership, such as patients, caregivers, and members of the public. Successfully gathering and implementing this feedback leads to a much more accessible and meaningful PLS. Ideally, the upcoming NIH PLS policy will encourage such user testing and provide recommendations on how to best collect and utilize the feedback.

Establishing strong processes is essential

Developing and distributing high-quality PLS in a timely fashion requires well-defined and executed processes. Under the EU CTR, the PLS must be available within strict timelines following study completion. While not held to the same strict timelines, appropriate translations must also be provided in a reasonable timeframe. These requirements help ensure that PLS reach participants quickly and in their primary language. The NIH PLS policy will hopefully include similar timeline and translation requirements. The GLSP provides valuable insights regarding PLS planning, including timing of key process steps, cost implications, and dissemination strategies. The GLSP serves as an excellent starting point for sponsors to create specific processes that align with their own internal workflows.

The PLS should not just be an end-of-study activity but instead requires planning from the start of a study. Early planning should extend beyond content development to include dissemination strategies, such as how participants will be actively notified when a summary is available, where they can access it, and what options exist for participants who no longer have regular contact with the study site. Sponsors can incorporate this information in the informed consent process or communicate it through separate material, such as a thank you card. When working across multiple studies, sponsors often find it helpful to maintain a robust tracking system for study end dates and source document availability to ensure posting deadlines are met and PLS drafting can start as soon as possible. Additionally, defining and reporting key performance indicators, especially with regards to specific process steps, has proved helpful in identifying which steps work well and which may need fine tuning. Establishing designated study-specific PLS reviewers and approvers with appropriate subject matter expertise (i.e., statistics, legal, etc.) and equipping them with appropriate PLS review guidelines/training materials is also helpful to ensure appropriate resourcing and avoid delays. Finally, the use of AI to support PLS drafting has become increasingly popular. AI can reduce timelines and resourcing burden but must be used thoughtfully. A multi-stakeholder working group discussed AI for the creation of PLS in the June 2025 issue of Medical Writing.⁵

The NIH should also clarify expectations for IRB or Human Research Protection Program review of plain language summaries and return-of-results plans. Under the EU CTR, ethics committee review is not generally expected for summaries submitted after the end-of-trial notification. For NIH-funded research, it would be helpful to distinguish between review of the overall return-of-results plan, which may appropriately be considered during protocol and consent review, and review of every final summary document, which may not be necessary when the summary follows the approved plan and does not raise additional participant privacy or safety concerns.

As the NIH develops its PLS policy, it should consider not only when and how PLS are shared but also the operational realities of creating them. Establishing realistic timelines and providing implementation guidelines aligned with established resources and best practices would help organizations develop PLS efficiently and effectively.

The Opportunity Ahead For NIH — And For Participants

The NIH’s forthcoming PLS policy represents an important milestone in advancing transparency and recognizing participants as valuable partners in research. By leveraging the lessons learned through years of PLS development under the EU CTR, as well as existing resources such as the GLSP and the expertise of organizations experienced in patient communications, the NIH has an exciting opportunity to establish a framework that not only meets the needs of patients but also supports consistent, efficient implementation across the diverse ecosystem of NIH-funded clinical research.

References:

1. Center for Information and Study on Clinical Research Participation (CISCRP). (2025, November). Perceptions and Insights Study Data Dashboard. CISCRP. “ciscrp.org/professional-services/perceptions-and-insights-studies/data-dashboards”
2. European Commission. Regulation (EU) No 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. https://ec.europa.eu/health/sites/default/files/files/ eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
3. European Commission. Good Lay Summary Practice. https://health.ec.europa.eu/ system/files/2021-10/glsp_en_0.pdf
4. Multi-Regional Clinical Trial (MRCT) Center. Clinical Research Glossary. https:// mrctcenter.org/health-literacy/tools/overview/glossary/
5. Edwards (2025), on behalf of a multi-stakeholder working group. Considerations for the use of artificial intelligence in the creation of lay summaries of clinical trial results. Medical Writing, 34(2), 74-81. https://doi.org/10.56012/vmag9372

About The Authors:

Kim Edwards, Ph.D., is the senior director of health communication services at CISCRP, where she oversees the creation of easy-to-understand trial resources for patients, participants, and the public. Kim earned her BS in neuroscience from Trinity College and her Ph.D. in developmental and brain sciences from the University of Massachusetts Boston.

Malgorzata Sztolsztener, Ph.D., is the director of patient communication at AstraZeneca, leading global strategy and operations for plain-language communications required under clinical trial regulations. Her work focuses on translating complex data into clear, accessible information for trial participants while ensuring regulatory compliance. Malgorzata earned her Ph.D. in biochemistry from the Nencki Institute of Experimental Biology.