Lay trial titles
A lay title identifies a clinical trial for patients and the public across registries and study documents. Its wording balances understandable information, registry requirements and the distinctions that let readers find the right trial.
What the lay title is for
A person looking for a trial that is recruiting may go to a clinical trial registry such as ClinicalTrials.gov, and one of the first things they see there is the lay title, sometimes called the brief title. Titles are the most read part of any trial registry entry, and a trial's title may directly influence whether patients, caregivers or healthcare professionals want to obtain more information about it. Because most registries answer a search with a list of trial titles, the title is the key element in identifying the trials that interest them.
Informing potential participants about trials supports recruitment and accelerates clinical development; the lay title is often the first contact between patient and trial. An informative and understandable lay title helps a sponsor attract the appropriate target population, through registry entries and through trial-specific advertisements online, in print or in other channels.
Beyond large registries such as ClinicalTrials.gov, trial information reaches patients through local and national trial finders and through databases of hospitals, charities and patient advocacy groups; most of those carry a lay title alongside the scientific one, some carry only the lay title, and many import their data, the lay title included, directly from ClinicalTrials.gov. The wording therefore affects how readily patients find the trial, and the lay title may be its most important public sentence. A poorly written lay title could mean that patients miss the opportunity to take part in a trial that could benefit them.
Written for the scientific community, a scientific title is usually too complex to give patients and the general public insightful information.
One title across the trial's documents
A trial should have one lay title across its documents because this is its main public identifier. The lay title serves different purposes across the trial documents.
| Timing | Document | Purpose of the lay title |
|---|---|---|
| Before the trial | Clinical trial protocol | Link scientific and participant-facing material |
| Before the trial | Informed consent form | Give an initial impression, identify the trial and provide key information |
| During the trial | Trial advertisement | Give an initial impression, identify the trial and provide key information |
| During the trial | Registry posting | Give an initial impression, identify the trial and enable retrieval |
| After the trial | Clinical trial report | Link scientific and participant-facing material |
| After the trial | Lay summary of results | Identify the trial |
Trial identification means identifying the participant-facing material for a particular trial; retrieval means finding it through a search term. The lay title is the link between the trial-related documents from registration to the provision of results. To help potential participants understand the purpose of a trial, it should also be used on informed consent forms or trial information leaflets. After the trial, a good lay title helps patients and their doctors find the results of the trials they took part in, or of other trials relevant to them, which is why it should also appear on the lay summary of the results.
One sponsor develops a lay title routinely for every clinical study from the full scientific title and the final study protocol, and uses it in other study documents, such as informed consent forms, and in the posting on ClinicalTrials.gov.
Registry requirements and uniqueness
Many registries require a version of the trial title that is understandable to the lay public in addition to the scientific title, and ClinicalTrials.gov requires every trial posted to have a brief title written in language intended for the lay public. Every registry contributing to the WHO International Clinical Trials Registry Platform must provide a scientific and a lay title for each trial — the public title in the platform's terms, the brief title in the US registry's — and in many registries the title displayed in response to a search is the lay title. The US registry's data element definitions describe the brief title as a short title of the clinical trial written in language intended for the lay public, which should include, where possible, information on the participants, the condition being evaluated and the interventions studied. The term brief title describes length without conveying the requirement for language intended for the lay public. ClinicalTrials.gov limits the brief title to 300 characters including spaces. In practice, registry reviewers have occasionally asked for the phase, the randomisation and the blinding to be left out, for abbreviations to be explained, for the title to be a single sentence, for no full stop at the end, and for a trial acronym to appear only at the end — expectations that did not arrive for every title, so they appear to depend on the individual reviewer.
Distinct lay titles help searchers tell similar trials apart, but lay titles mention fewer distinguishing features than scientific titles, making subtle differences difficult to convey, especially in early development where individual trials may differ very little. Single rising dose and multiple rising dose phase I trials, for example, are distinguished only by how often the substance is taken. To keep the lay titles of similar trials unique, adding the trial acronym is recommended where one exists, though acronyms might be cryptic, hard to read and so likely to confuse a lay reader.
Because of length and content restrictions, and the need to translate medical concepts into lay language, a lay title inevitably deviates from the scientific title. Translating complex medical or technical concepts into lay terms often increases the word count, which is one reason a lay title can give only limited detail about the trial, and specific details on design, procedures or population may be difficult to include within the requirements for length and lay language. As a result, some ethics committees might find that the title on the patient information or the informed consent form omits important information, or is not consistent with the scientific title. Sponsors need to balance registry requirements, readability, permitted and required detail, and fidelity to the scientific title and trial objective.
Content and terminology
A lay title should be understandable to the public, and a well-written one is not only easy to read but also informative, telling the reader the topic of the trial, the interventions being studied and who the trial is for. One example, a study to test whether taking a named medicine for eight weeks helps people with post-traumatic stress disorder, states in one sentence the purpose of the study and the patients it addresses. The title should be informative, as specific as possible, accurate and careful not to mislead about potential benefits. Conciseness meets formal limits and helps a title make an impression and be remembered; including the research design may inform but usually makes the title longer.
At minimum the lay title should give the name of the substance or intervention, the target population, and ideally the aim of the trial. For the substance the choice is between the international nonproprietary name, the lab code and the trade name: the trade name is likeliest to be recognised by patients, but trade names differ by country and region and can change over time, so the recommendation is the nonproprietary name, with the lab code where no nonproprietary name exists.
Describing the target population usually means naming a specific disease or subtype of a disease. Common disease names such as diabetes or asthma are often familiar to the public; rarer diseases and complicated medical names are unlikely to be understood widely, although patients with the diagnosis are likely to know them. To make the title meaningful for the wider public but specific enough for the target population, it can help to give both the wider concept of the disease and the medical name, as in patients with the skin disease palmoplantar pustulosis. Where length permits, adding sex, the required age range or required background medication can help the title address the relevant patients.
Describing the aim within the constraints of a lay title can be challenging. The lay title should focus on the primary objective even at the cost of information the scientific title carries, and it is useful to define standard phrases for specific scientific terms, pharmacokinetics becoming how the substance is taken up by the body, which also helps harmonise titles across trials. How often a word is used in everyday language might also be worth weighing. Abbreviations cut both ways: laypersons could find them helpful because they reduce the number of complicated technical words, and some, such as HIV, might be commoner than the long form, but registry reviewers may ask for abbreviations to be explained at first occurrence, which is technically the title itself.
Title format
A lay title can take a conventional title format or the form of a sentence. A sentence format might be easier to read because it can divide complex information over two short sentences and allow more detail, helping patients identify relevant trials and distinguish similar ones. However, registry reviewers do not always accept multiple sentences, and readers may not recognise sentences as titles: familiar titles are fragments that anticipate the content, recognised by position and structure. Two worked trials illustrate scientific, sentence-format and conventional lay titles.
| Trial | Format | Wording |
|---|---|---|
| 1 | Scientific title | Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising intravenous doses of Testdrug in healthy male subjects (single-blind, partially randomised, placebo-controlled design) |
| 1 | Sentence | This study in healthy men tests how different doses of Testdrug are taken up in the body and how well Testdrug is tolerated. |
| 1 | Title | A study to find a suitable dose of Testdrug in healthy men and to test how different doses of Testdrug are taken up in the body |
| 2 | Scientific title | A randomised, double-masked, double dummy, placebo and active controlled study to evaluate the efficacy, safety and tolerability of orally administered Testdrug for 52 weeks in patients with mild visual impairment due to center-involved diabetic macular edema (DME). ACRONYM1 |
| 2 | Sentence | This study tests how well Testdrug is tolerated and how effective it is. This is studied in patients with mild eye problems because of diabetic macular edema. ACRONYM1 |
| 2 | Title | Effects of Testdrug in patients with mild eye problems because of diabetic macular edema – ACRONYM1 |
The title should be in the present tense, because it will be used on documents at any time during the conduct of the trial. It should be in the active rather than the passive voice, which is clearer and easier to understand. Lay titles often need to be translated, some words and phrases are hard to translate into certain languages, and a word-for-word translation might in some cases give a misleading description of the trial; because the translator might not be familiar with the medical content, the language should be as clear as possible.
Who writes the lay title
A single function should ideally write lay titles to ensure consistency and quality. Medical writers are a recommended choice because they balance information, compliance and patient understanding, and develop consistent standards and messages across documents. A continuously updated repository of the sponsor's lay titles can help consistency; recording each trial's scientific title, phase and indication also helps develop standards and harmonise titles across designs and therapeutic areas.
Completeness and readability in practice
An assessment of a representative sample of US registry records from 2017 and 2018 found brief titles reaching only 52% of the maximum patient-focus score.
A study of the lay titles of industry-sponsored interventional phase II/III and phase III trials posted on the US registry in 2021, extracted in February 2022 for four search terms — bowel disease, dementia, chronic kidney disease and breast cancer — covered 74 titles. Each title was scored for the presence of four recommended elements, the intervention, the target population, the scientific aim and the condition. It was scored for technical terms, with Latin words such as versus, receptor names and mode-of-action detail counted as technical and the substance and disease names not. It was given an overall expert verdict of adequate or needing improvement, the latter for titles that lacked important information, were very complicated, used cryptic terminology, or had grammar problems such as unclear pronoun references or unclear sentence structure. Its length and its use of a trial acronym were also measured.
Only 28% of the titles included all four recommended elements, 47% had three and 23% two; only 27% were free of technical terms, 31% had one and 42% had two or more; and the experts judged only 49% adequate. The abundance of technical terms is not surprising, because they are shorthand for complex content and lay-friendly expressions are usually longer and do not always cover every aspect of the technical term, but technical expressions may drastically limit a title's understanding and usefulness, particularly for the general public. Deciding whether a term is technical can be hard, since some terms are well known to people living with a disease but not to the wider population, and the terms that recurred show how the line was drawn.
| Term | Frequency among the 74 titles | Counted as technical? | Rationale |
|---|---|---|---|
| Metastatic/metastasis | 26% | No | Likely to be known to people living with cancer |
| Safety and efficacy, or efficacy and safety | 26% | Yes | Non-informative terminology whose full meaning is unlikely to be known to non-specialists |
| Placebo | 14% | No | Widely known; potential participants need to know they may receive it |
| Moderate to severe, or a variation | 9% | Yes | Investigator grading may differ from patients' assessment, and its rationale is unclear to most patients |
| Versus | 8% | Yes | Latin term with confrontational connotations that do not fully reflect the intended comparison |
| Trial phase | 7% | Yes | Unlikely to be understood by non-specialists |
Title length
All the titles were within the 300-character limit, from 56 to 283 characters, with a median of 118 and a mean of 127; 89% had fewer than 200 characters and 41% fewer than 100. All four elements appeared in 41% of the titles of 100 characters or more but in only 10% of the shorter ones, and the experts judged 55% of the longer titles adequate against 40% of the shorter — though the shorter titles were more often free of technical terms, 37% against 20%. Plain-language guidelines recommend short sentences because they are easier to understand, but for lay titles the analysis suggests that an emphasis on brevity comes at the cost of the recommended elements.
Acronyms in the sample
Forty-three of the 74 titles (58%) contained an acronym, and 84% of these were correctly entered in the registry's acronym field; seven trials omitted that entry. Titles with acronyms were longer on average, contained fewer technical terms and more recommended elements, and were more often judged adequate; sponsors developing acronyms might also take greater care over other title attributes. Sponsors create acronyms to make communication about a trial easier and more memorable, and possibly as an element of branding, since some are reused for follow-up trials; an acronym also gives cohesion across communication channels such as publications, posters, flyers and regulatory documents like the consent form, the clinical trial report and the lay summary. Positive-sounding acronyms or those suggesting a favourable outcome can be manipulative and may unduly influence participation decisions. The trial acronyms in the sample illustrated several possible connotations.
- Positive outcomes: PRESERVE 2, STABILIZE-CKD, EASE SBS 3, CORRECTION, CONVERSION, ELEVAT UC 40 JAPAN and TRAILBLAZER-ALZ 4.
- Strength or other positive qualities: ENIGMA-SC, ZEUS, EPIK-B5, STARS extend, DESTINY-B12 and ARTEST.
- Women's names, potentially conveying caring, loving or healing: EMBER-3, SERENA-6, KATE3, Astefania and OVELIA; ovelia also means help in Greek.
- Familiar-sounding words with different spellings: ARTEST sounds like artist and EPIK-B5 like epic, which could confuse searches for a particular trial.
- Disease, organ or gene-mutation abbreviations: TROPION-Breast01, STABILIZE-CKD, FIND-CKD, HER2CLIMB05, TRAILBLAZER-ALZ 3 and TransportNPC; these may mean something to people with the disease or healthcare professionals without meaning anything to the general public.
Many acronyms lack a direct link to the disease or trial. To be truly helpful, an acronym should relate to the trial, be easy to pronounce and remember, and be neither misleading nor coercive.