Company insight Clinical trial transparency
Lisa Chamberlain James, senior partner at Trilogy Writing & Consulting, and Julie Holtzople, president at Holtzople Consulting, write about the shift towards clarity and collaboration in a changing regulatory landscape.
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n the evolving world of clinical research, transparency has emerged as not merely a regulatory requirement but a critical ethical and scientific imperative. Transparency is being redefined – not just as a compliance checkbox, but as a value- driven commitment to public trust, data utility and meaningful engagement.
What is clinical trial transparency? At its core, clinical trial transparency means making trial information accessible to all stakeholders: regulators, researchers, sponsors and the public. It spans the registration of trials, reporting of outcomes, sharing of data and publication of summaries – including those written in plain language. Fundamentally, transparency is making clinical trial information available to all the stakeholders who need it or could use it or possibly want it in the format that is useful to them.
This philosophy aims to reduce duplication, improve data reuse and uphold the integrity of scientific communication. But doing it well is far from simple.
Leveraging AI in the transparency toolbox
The landscape has seen advancements through the integration of AI. AI tools are being developed that can assist in the anonymisation of data sets and clinical study reports (CSRs) for safe sharing on regulatory and data sharing portals. AI is proving valuable in managing the vast variability in document formatting and structured data terminology – like the many ways to refer to a patient ID. Another promising area is the use of generative AI for drafting plain language summaries (PLSs) of clinical trial results and protocol synopses. However, while AI can deliver first drafts efficiently, it’s essential to keep human experts ‘in the loop’ to ensure accuracy of complex
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clinical data, correct reading tone for the intended audience and to make sure that there are no hallucinations.
Responsible innovation: best practices
A recent paper titled ‘Considerations for the use of artificial intelligence in the creation of lay summaries of clinical trial results’ published in volume 34: Issue 2 of the EMWA Medical Writing journal lays out best practices for responsible AI use in writing PLSs. This paper highlights the need for critical evaluation and strategic oversight from human experts to ensure quality and compliance.
doesn’t yet carry a legal imperative, making it less commercially attractive for vendors. However, as EHDS moves forward, its impact could be transformative, encouraging more sponsors to prioritise value and utility over tick-box compliance.
Strategic advice for sponsors and medical writers
For those new to transparency initiatives, there are seasoned experts and established practices worth following. The focus should be not only on meeting legal obligations but also on delivering genuine value to stakeholders – whether
“At its core, clinical trial transparency means making trial information accessible to all stakeholders: regulators, researchers, sponsors and the public.”
The approach is straightforward: AI should assist, not replace, expert judgment. Whether it’s summarising protocols for
CT.gov or aligning with regulatory expectations, AI-driven tools should work under expert supervision.
Regulatory shifts: from compliance to opportunity While regulatory frameworks – like EMA’s Policy 70, also called Clinical Data Publications and
clinicaltrials.gov requirements – have guided transparency efforts for years, the future holds broader initiatives. The European Health Data Space (EHDS), currently in planning and implementation phases, is set to mandate controlled structured data sharing across Europe. This represents a major shift from optional good practice to legal requirement.
It is worth noting that structured data sharing is often overlooked because it
through readable summaries, reusable data or ethical openness.
Sponsors are urged to ask not just ‘what must we do?’ but ‘what can we do better?’ Transparency done well isn’t just good science – it’s good stewardship.
The road ahead
As clinical trial transparency becomes embedded in scientific culture, the role of medical writers, sponsors and regulators will only grow more nuanced. With AI tools evolving and regulation tightening, the field is entering a phase where collaboration, clarity and strategic thinking are more crucial than ever. Transparency is no longer a challenge to manage – it’s an opportunity to lead. ●
References available on request.
https://trilogywriting.com
https://holtzopleconsulting.com
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