Medical Writing Public Disclosure Lay titles for clinical trials: A balancing act
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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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  7. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014.
  8. National Institutes of Health, Department of Health and Human Services. Clinical Trials Registration and Results Information Submission; Final Rule (2016, Sept 21). 81 FR 64981; 42 CFR Part 11.
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