Rethinking Plain Language in Clinical Trial Registrations

Sponsors should not abandon plain language but apply it strategically. Below we outline four recurring problem areas in trial registrations.

Clinical trial recruitment remains one of the industry’s most persistent challenges. Despite major investment in patient engagement and digital platforms, most trials still miss enrollment targets. The core problem is familiar: connecting the right patients to the right trials at the right time.

Plain language in trial registrations has been viewed as part of the solution. TransCelerate’s Clinical Research Access & Information Exchange (CRAIE) research, published in PLoS One. Since ClinicalTrials.gov is the backbone of the US registry ecosystem and the feed for many downstream applications, improving accessibility is critical.

But a recent patient–physician experience, shared at the TrialScope Extra user conference, underscored the risks of oversimplification. Emergency physician and patient advocate Dr. Bess Stillman described the challenges of navigating trial information for her husband with advanced cancer. Her message was clear: In certain fields, precision matters more than simplification.

When time is life

Stillman built a detailed record of her husband’s medical history and consulted numerous oncologists. Each produced different lists of potential trials from ClinicalTrials.gov with no overlap. Variations in keyword searches produced thousands of differing results, and a promising option was missed entirely because of how the condition was labeled.

“The lack of keyword standardization started to drive me a little bit crazy,” she explained. “Choosing the right study was the difference between maybe keeping Jake alive long enough to meet our daughter … and having him die.”

Even with her medical training, she struggled to interpret unstandardized terminology, incomplete eligibility criteria, and outdated registry data. Oversimplification, she concluded, created new risks rather than reducing barriers.

Where plain language falls short

This experience illustrates four recurring problem areas in trial registrations.

• Clarify eligibility criteria: Oversimplification and delayed updates can cause conflicting site answers.
• Disclose all significant criteria: Withholding medically relevant details wastes time and delays access when patients learn of ineligibility late.
• Standardize condition terminology: Even small wording differences can distort search results and cause trials to be overlooked.
• Update registry data promptly: The 30-day window may meet compliance but can be devastating for patients with a fast-progressing disease.

To address these risks, sponsors need to distinguish where precision is essential and where plain language adds value.

Strategic precision vs. plain language

The lesson is not to abandon plain language but to apply it strategically.

Where precision is essential:

• Detail eligibility criteria fully: Ensure they are standardized across sites.
• Use consistent condition classifications: Enable reliable searches with controlled terms.
• Cross-reference intervention names: Include synonyms and identifiers.
• Define prior therapy clearly: Specify what constitutes a line of therapy and how repeat treatments are classified.

Where plain language adds value (per CRAIE research):

• Write accessible brief titles: Use broader condition terms.
• Explain key facts in brief summaries: Include treatment duration, study purpose, and expectations in full sentences.
• Give high-level study descriptions: Outline procedures and commitments.

Implications for disclosure teams

For disclosure teams, the following actions can translate these principles into practice.

• Audit eligibility criteria: Confirm all medically significant details are disclosed.
• Accelerate updates: Supplement registry timelines with faster sponsor-driven updates when possible.
• Standardize terminology: Adopt controlled vocabularies for conditions and interventions.
• Balance transparency with strategy: Protect competitive details, but do not withhold medically relevant information.

Ultimately, the success of registration is measured not only by compliance but by how effectively it enables qualified patients to discover and pass screening. Today, only 0.2% of oncologists actively refer patients to clinical trials, with most citing unclear information as the primary barrier.

Moving forward

Plain language remains vital for patient engagement, particularly in results summaries and study descriptions. But precision in eligibility and condition data is just as critical — if not more so — for recruitment success.

Stillman’s husband ultimately gained additional months of life through a clinical trial —time that allowed him to prepare for the future of his family. For patients in similar circumstances, oversimplification doesn’t just create frustration; it can mean the difference between access and lost opportunity.

As disclosure practices evolve under ICH E6(R3) and global transparency reforms, the industry must recognize that patients are best served when plain language is applied thoughtfully, and when medical precision is preserved where it truly matters.