Medical Writing Public Disclosure Lay titles for clinical trials: A balancing act

Volume 27, Issue 2 - Public Disclosure

Lay titles for clinical trials: A balancing act

Abstract

With increasing transparency demands andthe new legal requirements for providingclinical trial information to lay readers, clinicaltrials need to be given titles that patients canunderstand and recognise. Trial titles informthe readers what the trial is about, whatsubstances are studied, and who the targetpopulation is. Devising a lay title is challengingas it needs to be understandable to lay readers,fully identify the trial, meet registryrequirements, and also be translatable intodifferent languages. Lay titles also need to fitdifferent types of documents, e.g. trialprotocols, trial advertisements, informedconsent forms, and lay summaries. As the laytitle is one of the first pieces of informationthat is displayed, good lay titles help patientssearching clinical trial registries for trialparticipation. For sponsors, informative andunderstandable lay titles increase the chancesof attracting the target patient populations forclinical trials.

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References

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President’s Message
EMWA News
The Regulatory Public Disclosure Special Interest Group
Clinical trial disclosure and transparency
Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on ClinicalTrials.gov and EudraCT
Writing lay summaries: What medical writers need to know
Lay titles for clinical trials: A balancing act
Why clinical study reports really matter
CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure
Preparing clinical study reports for external sharing
Harmonising format and style requirements for scientific and medical publications
News from the EMA
Winners of the Geoff Hall Scholarship Essay Competition
Creative medical writing: An oxymoron?
Creative medical writing - An oxymoron?
An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
Upcoming issues ofMedical Writing

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