Medical Writing Patient-reported outcomes Protecting the rights of clinical trial patients through disclosure: The significance of plain language

Volume 27, Issue 4 - Patient-reported outcomes

Protecting the rights of clinical trial patients through disclosure: The significance of plain language

Abstract

Taking a step back to understand the history of clinical trial regulation triggers a broader perspective on the work we do or the work we will do. As regulatory medical writers, our role is often limited to the more technical
submission-level component of either a trial design or a trial outcome. With the advent of plain language summaries (also known as patient lay summaries), we have a unique opportunity to inform the clinical trial patient population directly, and in turn the wider public audience.

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References

  1. Walsh TM, Volsko TA. Readability assessment of internet-based consumer health information. Respir Care. 2008;53:1310–5. Available from: http://
  2. Singh N. Writing lay summaries: what medical writers need to know. Med Writ. 2018;27(2):49–54. Available from: http://
  3. Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Perspect Clin Res. 2010;1:6–10. Available from: http://
  4. Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med. 1997;337:1436–40. Available from: http://
  5. Resnik DB. Research ethics timeline (1932-present). Available from: Available from: https://www.niehs.nih.gov/research/ resources/bioethics/timeline/index.cfm.
  6. Greene JA, Podolsky SH. Reform, regulation, and pharmaceuticals – The Kefauver-Harris Amendments at 50. N Engl J Med. 2012;367:1481–3. Available from: http://
  7. Centers for Disease Control and Prevention. What is health literacy? Available from: Available from: https://www.cdc.gov/healthliteracy/learn/.
  8. Goldstein T. The plain-language movement is gaining. The New York Times. 21 August 1977. Available from: http://
  9. US National Library of Medicine. Clinicaltrials.gov. History, policies, and laws. Available from: Available from: https://clinicaltrials gov/ct2/about-site/history.
  10. Sundin M. Plain English and Swedish klarsprak, a comparison between plain language movements, style guides and practice. Available from: Available from: http://www.textfixarna.se/wp-content/ uploads/2013/01/plain_english.pdf).
  11. The Center for Information and Study on Clinical Research Participation (CISCRP). Public and patient perceptions and insights study. 2017. Available from: Available from: https://www.ciscrp.org/services/researchservices/ public-and-patient-perceptionsinsights- study/.
  12. Fight the fog. European Commission. How to write clearly. Available from: Available from: http://www.au.af.mil/au/awc/awcgate/ eu/fight_the_fog_en.pdf.
  13. National Center for Health Marketing. Plain language thesaurus for health communications. Draft Version 3; October 2007. Available from: Available from: https://www.orau.gov/hsc/HealthComm Works/MessageMappingGuide/resources/ CDC%20Plain%20Language%20 Thesaurus%20for%20Health%20 Communication.pdf
  14. Centers for Disease Control and Prevention. Everyday words for public health communication. Available from: Available from: https://www.cdc.gov/other/pdf/ everydaywords-060216-final.pdf.
  15. Quick guide to health literacy. US Department of Health and Human Services. Available from: Available from: https://health.gov/communication/ literacy/quickguide/factsbasic.htm.

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Estimands – closing the gap between study design and analysis
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News from the EMA
Regulatory Matters & Regulatory Public Disclosure
Medical Communications
Medical Devices
Journal Watch
In the Bookstores
Good Writing Practice
Getting Your Foot In The Door
My First Medical Writing
Out on Our Own

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