Brief study summaries

Brief study summaries give prospective participants an accessible overview of a trial so they can decide whether to seek more information.

Purpose and content

ClinicalTrials.gov requires a Brief Summary giving a high-level account of the study for potential participants. ^{1, 2, 3} It appears below the brief title, with the full, often complicated trial title and expandable information further down the record. ^{1, 4}

The summary includes main eligibility criteria, study purpose, treatment, route of administration, dose and frequency, study duration, and possibly the number of visits and assessments. ^{1, 5} This information helps patients decide whether to learn more and discuss the study with their doctors. ⁵ Summaries also appear on sponsor and multi-sponsor websites, and ClinicalTrials.gov provides a template and general lay-language guidance. ^{5, 6}

Neutral information and unanswered questions

Prospective participants may want to know whether a new medicine is safe, what will happen if they take it or whether it is better than another medicine, but a brief summary or recruitment video cannot answer those questions. ⁴ Information must focus on the trial being described, should not include results of other trials, and should remain neutral and non-promotional. ⁷

Plain-language guidance

On 26 September 2022, ClinicalTrials.gov added the NIH Plain Language Checklist for Lay Brief Summaries to its support materials to help investigators write summaries understandable to the public. ^{8, 9, 3} The checklist supports both the required Brief Title and Brief Summary fields. ^{8, 3} Its addition reinforced the role of plain language in registry entries. ¹⁰

Brief summaries should explain the trial’s goal and intended indication in lay language, yet a 2022 practitioner described many as specialist writing rather than patient information. ⁸ Before the checklist, the registry had supplied little guidance on summary content; the practitioner regarded the addition as a substantial improvement while noting that it covered familiar plain-language principles. ⁸ He argued that professional writers with plain-language expertise were better placed than many study managers or investigators to create useful summaries consistently across disease areas in large organisations, opening an area of work for those writers. ⁸

Brief summary videos

Some sponsors supplement text summaries with videos about upcoming trials; Boehringer Ingelheim calls these brief summary videos. ^{5, 4} A sponsor’s rationale was that text could be overwhelming and less engaging, while videos could be more appealing and support recruitment. ⁶

Production effort and time, including ethics approval in each country, led that sponsor to favour trials with long recruitment periods rather than, for example, only two months. ¹¹ Its BRIGHTLINE-1 video appeared on a dedicated trial website and could also be shared through hospital websites or other channels; another was being prepared for BRIGHTLINE-3 in a similar indication in 2024. ¹¹ Local-language translations and subtitles supported access in participating countries. ^{11, 12}

A trial-video example

The BRIGHTLINE-1 example concerned advanced dedifferentiated liposarcoma, with eligibility explained as age eighteen or older and no other cancer medicines. ^{11, 13} The narration introduced the condition and symptoms before explaining the protein targeted by the investigational medicine. ^{14, 13} It described the comparison between the investigational MDM2 inhibitor BI 907828 and the chemotherapy doxorubicin. ¹⁵ Random assignment was explained as allocation by chance to tablets or an infusion into a vein every three weeks. ¹⁵ The video said that participants not benefiting from doxorubicin might switch to BI 907828 after doctors checked their eligibility, while acknowledging that switching might not be possible. ¹⁵ It described regular health and unwanted-effect checks, tumour size and spread assessments, and a tumour tissue sample for testing. ^{15, 16}