Clarity isn’t just a regulatory requirement. It’s the foundation for trust, efficiency, and better outcomes in clinical trials.
Compliance may be the catalyst.
But connection is the outcome.
The FDA’s 2020 guidance on patient engagement encourages use of plain language communication, especially when involving patients in early-phase protocol design.
And as plain language protocol synopses (PLPS) become a formal requirement under regulations like the EU Clinical Trials Regulation (CTR 536/2014), it’s easy to view them as just another box to tick.
That would be a missed opportunity.
PLPS are not just about compliance. It’s about creating understanding in an environment that desperately needs it. It’s about bringing clarity to a process that is too often clouded by jargon and internal lingo. And above all, it’s about connecting people to trials, to decisions, and to outcomes that matter.
Why Plain Language Matters
Clinical trials have never been more complex.
Multi-arm studies, decentralized designs, global participant cohorts, and hybrid regulatory frameworks have become the norm. And that’s a good thing as clinical research grows and is increasingly diversified and globalized.
Yet the documents we ask patients, and even some site staff, to engage with often remain unclear. According to a 2023 Health Literacy study, 88% of US adults have substandard rates of health literacy.
That’s not a problem of education. It’s a failure of communication.
Clarity is not about dumbing down content.
It is about translating complexity into something that can be trusted, explained, and acted upon.
In this context, a well-written PLPS becomes a strategic tool, not just for patients, but also for ethics committees, trial teams, and CROs navigating approvals and alignment.
PLPS: More Than a Regulatory Obligation
The CTR 536/2014, for example, mandates a PLPS as part of the clinical trial application, requiring a two-page, non-technical summary of the protocol aimed at lay audiences.
But even beyond regulations, many IRBs increasingly request lay summaries or plain language protocol explanations, especially for inclusion in informed consent processes.
What’s more:
PLPS improves ethics committee review by providing immediate clarity.
It helps recruitment teams communicate value and context.
It reduces back-and-forth with sites seeking clarity on trial design.
It fosters internal alignment among sponsors, CROs, and operations teams.
In short, a good PLPS doesn’t just comply; it amplifies your communication across stakeholders.
What Makes a PLPS Effective?
A check-the-box document? That’s not enough.
A truly effective PLPS does four things:
Takes an audience-first approach.
It’s not written for regulators. It’s written for patients, families, and site staff.Balances clarity with accuracy.
The science remains, but the jargon doesn’t.Uses layout and formatting wisely.
Short paragraphs, clear subheadings, plain language vocabulary, and whitespace.Supports localization and inclusion.
Multiple languages, cultural nuances, and reading-level accessibility matter; especially in global trials.
“We should measure PLPS not by length, but by clarity and usefulness.”
Where Clinials Comes In
At Clinials, we’ve been helping clinical teams, communication leads, and patient recruitment groups produce compliant, clear, and multilingual PLPS documents with speed and accuracy.
Our platform supports:
Built-in readability logic and plain language guidance.
Multilingual and region-specific versions.
Rapid output formats for both ethics and patient-facing use.
Structured templates to avoid the dreaded blank page.
Use case snapshot:
One staff at a site network, in the USA, managing trial materials for the network, used Clinials to generate a PLPS, operational summary, patient information sheet and recruitment materials in under 10 minutes. Something that used to take over two days and require multiple rounds of rewriting.
Because clarity shouldn’t come at the cost of time.
Connection is a Competitive Advantage
In the current, global, clinical trial landscape where timelines are tight (and getting tighter), recruitment is harder, and patient trust is harder still, clarity isn’t a soft skill, it’s a survival trait.
Plain language documentation, and medical simplification, isn’t just about getting approval. It’s about helping people understand what they’re signing up for.
That’s what builds trust. That’s what reduces dropout. That’s what gets trials over the line.
Ready to make plain language your competitive edge?
Let Clinials help your team turn complexity into simplicity.
And turn regulatory necessity into real-world clarity with speed, structure, and confidence.
