Journal for Clinical Studies Volumne 13 edition 5

Plain Language Summaries of Publications – what has COVID-19 taught us?

Authors: Lisa Chamberlain James and Rachel Beeby

Journal for Clinical Studies. October 2021

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. Plain Language Summaries of Publications (PLSPs) could be an elegant and much-needed solution to this problem. This article will explore what these documents are, the approaches taken to date, and the challenges that still remain. The authors will aim to answer the question – what has COVID-19 taught us?

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JCS Summer 2021

Communicating with Patients. Who and How?

Author: Lisa Chamberlain James

Journal: Journal for Clinical Studies. June 2021

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. In this article, Dr. Lisa Chamberlain James explains why communicating with patients is key and how the new regulations will reshape the conversation about patient-friendly versions of regulatory documents.

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Regulatory Rapporteur - Article #67 Cover

Do We Need to Involve Patients in Clinical Study Report Lay Summaries?

Authors: Lisa Chamberlain James and Barry Drees

Journal: Regulatory Rapporteur. September 2020

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, not just during the trial itself, and that the involvement of the patient community can not only make the final lay summary much easier to produce but can also enrich the clinical development process and make the results much more fit for purpose for patients themselves.

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Trilogy Writing's Special Edition No. 2

Writing for Patients: When and How

Authors: Lisa Chamberlain James, Deborah Collyar, Allen Todd, Catina O’Leary

Journal: Medical Writing Special Edition No. 2. February 2020

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, accompanied by new regulations mandating that pharmaceutical companies engage with patients and the general public in a way that has been improbable up to now. While this has generally been supported and welcomed by both industry and patients, the initiative has brought with it considerable challenges.

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Lay Summaries and Writing for Patients

Author: Lisa Chamberlain James and Trishna Bharadia

Journal: Clinical Trials Insight. Winter 2019

Lisa Chamberlain James of Trilogy Writing & Consulting and Trishna Bharadia, patient engagement consultant, examine the trend for increasing and more transparent patient information, and ask how close we have come in the past few years to producing useful and meaningful information for patients.


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The Lay Summary – Remember the Reader

Authors: Lisa Chamberlain James and Barry Drees

Journal: Journal for Clinical Studies. Winter 2017

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).

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