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Topic: Lay Summaries

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Episode 23: Speaking of Buzzwords in Medical Writing, What About AI? – Part II
Welcome back to TriloTalk! As promised, we are continuing the conversation about buzzwords in medical writing. In this episode, our guests Lisa and Art explore the topic of medical writing...
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Communicating With Patients: Why It Matters and How to Do It Better
Welcome to the Medical Writing Supplement of International Clinical Trials. We are delighted to present this edition, where we explore the landscape of communication with patients and the general public....
Journal: Medical Writing Supplement of International Clinical Trials, ICT
Date: February 2024
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Episode 19: Elevating the voice of patients: the role of medical writers in making a difference
In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, and Magnolia Correa, Marketing Communications Manager at Trilogy Writing & Consulting, delve into their shared passion for...
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Episode 12: PIF and PIF Tick. What are these and why are they important?
In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting talks to Dan Wills, Quality Mark Manager at Patient Information Forum (PIF) about the PIF TICK accreditation and its...
Date: September 2022
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Writing Lay Summaries
January 22, 2020 | London, UK Trilogy hosted a discussion on writing Lay Summaries and their experience on how to overcome the unique challenges found when writing these types of...
TriloTakes
TriloTake on Lay Summaries
Listen to Lisa Chamberlain James, Senior Partner at Trilogy, talk about her take on Lay Summaries – what are the opportunities and what are the challenges?
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Writing Lay Summaries
November 05, 2020 | Virtual Trilogy hosted a discussion on writing Lay Summaries and their experience on how to overcome the unique challenges found when writing these types of documents.
Lay Summaries
Episode 5: Lay Summaries
Writing for a non-specialist audience represents challenges beyond writing in a simpler language. Writing a fit-for-purpose document for the general public involves lay language, lay presentation, and lay science. Join...
Date: January 2022
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Plain Language Summaries of Publications – what has COVID-19 taught us?
The COVID-19 pandemic has significantly impacted the whole world and the public has had to struggle with understanding scientific data on a daily basis. The impact of scientific misunderstanding became painfully apparent with the decline in vaccine uptake and so the need for clear, understandable scientific information has never been more vital.
Author: Lisa Chamberlain James and Rachel Beeby
Journal: Journal for Clinical Studies
Date: October 2021
JCS-Summer-2021
Communicating with Patients. Who and How?
Despite the fact that patient-friendly versions of many regulatory documents are now mandated by the regulations, the most frequently encountered reaction to communicating patient information is apathy.
Author: Lisa Chamberlain James
Journal: Journal for Clinical Studies
Date: June 2021
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Do We Need to Involve Patients in Clinical Study Report Lay Summaries?
Translating complex clinical regulatory documents into versions that are understandable to patients and the general public was never going to be an easy task, but it is a very necessary, important, and now legally mandated one. This article argues that the advent of the clinical trial results lay summary requirement has highlighted the need for patient involvement in clinical trials at the very earliest stages.
Author: Lisa Chamberlain James and Barry Drees
Journal: Regulatory Rapporteur
Date: Vol. 17, Issue 9, September 2020
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Writing for Patients: When and How
In a drive for more patient-centric healthcare practices, medical writers are increasingly required to present medical and health information in an easy-to-understand, ‘plain language’ format. The move towards patient engagement and patient involvement in healthcare decisions (‘shared care’) has triggered a raft of new guidances from regulatory authorities.
Author: Lisa Chamberlain James, Deborah Collyar, Allen Todd, Catina O'Leary
Journal: Medical Writing Special Edition No. 2
Date: February 2020
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Lay Summaries and Writing for Patients
The most recent changes to regulatory legislation in terms of information for patients – the introduction of the lay summary of the risk management plan (RMP) and the lay summary of clinical trial results (CTRs) – have caused great discussion and concern in an industry very willing to provide information to patients, but more used to producing complex scientific information for regulatory authorities (RAs).
Author: Lisa Chamberlain James and Trishna Bharadia
Journal: Clinical Trials Insight
Date: Winter 2019
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The Lay Summary – Remember the Reader
In 2014, as part of its Clinical Trial Transparency initiative, the EMA mandated a requirement (CTR EU No 536/2014) for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (plain language) no later than one year after the end of the trial in the EU. These CTR lay summaries will be made available in a new EU database; it was planned for 2018, but it is likely that it will not now be implemented before 2020.
Author: Lisa Chamberlain James and Barry Drees
Journal: Outsourcing in Clinical Trials Handbook 2020
Date: 2020
emwa-2019
Lay Summaries and Writing for Patients: Where Are We Now and Where Are We Going?
We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers and the pharmaceutical industry as a whole in trying to comply with recent European requirements for the creation of lay summaries of key regulatory submission documents.
Author: Lisa Chamberlain James and Trishna Bharadia
Journal: Medical Writing, the journal of EMWA
Date: Vol. 28 No. 3, September 2019
Journal for Clinical Studies FC
The Lay Summary - Remember the Reader
As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (patients and others not in the pharmaceutical industry). The regulation (CTR EU No 536/2014) obliges the company to produce this summary of results for the lay audience one year after the end of the trial in the EU.
Author: Lisa Chamberlain James and Barry Drees
Journal: Journal for Clinical Studies
Date: Dec 2017, Vol. 9, No. 6
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Risk Management Plans and Summary for the Lay Reader
July 12, 2016 | Frankfurt, Germany Trilogy hosted a discussion on every-day challenges involved in meeting the guideline on good pharmacovigilance practices (GVP), the challenge of writing and managing Risk...
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Mind the Gap
Why the move for more and better patient information is gathering momentum.
Author: Lisa Chamberlain James
Journal: European Pharmaceutical Contractor, EPC
Date: March 2013
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Communicating with Patients - Common Sense or a "Black Art"?
Good patient information maximises the benefits and intended use of a medicine.
Author: Lisa Chamberlain James
Journal: Journal for Patient Compliance
Date: Vol.2, No.3, 2012