Topic: Lay Summaries
Podcasts
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 patient communication. They explore this topic from their different perspectives and discuss how medical writers contribute to enhancing health outcomes by crafting clear and impartial documents intended for the general public.
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 importance – specifically, what it means for organizations to have this certification mark and what it means for people in their search for high-quality health information.
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 Dr. Lisa Chamberlain James and Dr. Barry Drees as they discuss their knowledge and experiences in writing Lay Summaries.
Publications
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
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
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
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
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
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
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
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
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
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