This document provides an overview of plain language summaries (PLS) and a company's PLS program. It defines a PLS as a scientifically accurate, non-promotional translation of clinical trial results into easy-to-understand language. The document discusses the importance of sharing results with trial participants and investigators based on feedback from studies. It also reviews regulatory requirements for posting PLS, such as the EU Clinical Trials Regulation requiring posting within 1 year of study completion. Finally, it states that the company's PLS program information will be inserted to describe how it will implement PLS within timelines and any pilot studies.

1. <Date> <Location>
Plain Language Summary Roadshow
(Educational Material)

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Agenda
• Vision
• Overview of Plain Language Summary
• Plain Language Summary Program

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Vision
<Insert Company Vision>

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Overview of Lay Patient Summary
• “Translates” the technical results of clinical trials into easy-to-
understand language
• Scientifically accurate and non-promotional
• IALS Level 2-3 / US-equivalent 6th – 8th grade level
• Main elements:
1. “Thank You” to participants and recognition of their participation
in the study
2. An overview of the clinical trial based on information contained in
clinical study protocol.
3. A discussion of study results directly reflecting technical findings in
the clinical study report
Plain Language Summary

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Overview of Lay Patient Summary
Potential Content of a Lay Summary
• Thank you to the study participants
• If maintaining consistency with clinical study report & Annex V of the EU
Clinical Trial Regulation
• Clinical trial identification
• Name/contact of sponsor
• General information about the trial
• Population of subjects
• Investigational medicinal products used
• Description of Adverse reactions and their frequency
• Overall results of the clinical trials
• Comments on the outcome of the clinical trial
• Indication if follow-up trials are foreseen
• Indication where additional information can be found
If company has an example of Plain Language Summary, a picture of this could be included as an example for the Investigators

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Overview of Lay Patient Summary
Importance of Sharing Results
Patient Perspective:
• 95% of trial participants have positive experiences overall, but many feel let down at the end
of the study.1
o “You give them your last couple of blood draws and that’s it. You’re done with it.
Everything stops. You get cut off.”2
o “You are extremely well informed, but once you come off the trial there is not one letter.
Nothing...”3
Investigator and Site Staff Perspective:
• 49/50 support overall approach in qualitative evaluations, noting ethical responsibility and
patient interest.7
1. CISCRP. 2013. Perceptions and Insights Study.
2. CISCRP. 2012. Patient Experience Interviews.
3. Ramers-Verhoeven et al., 2014, as cited in IOM report
4. Shalowitz, D. and Miller, F. 2008. PLoS Medicine. 5:714-720.
5. Kost, R., et al. 2013. N Engl J Med. 369:2179-2181.
6. Sood et al. 2009. Mayo Clinic Proceedings. 84(3):243-247.
7. Getz K, et al. 2012. Expert Review of Clinical Pharmacology. 5: 149-56.

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Regulatory Landscape
United States European Union
• FDA Amendments Act (2007) allows HHS to
require “non-technical, understandable language
for patients” on ClinicalTrials.gov. Implementation
date uncertain.
• 2014 draft informed consent guidance:
“Investigators and sponsors can describe other
plans in the consent document for informing
subjects of the outcomes of the clinical
investigation.”
• SACHRP: “Agencies should take steps to promote
the return of general results to subjects, due to the
value of providing general results to subjects.”
• 2014 Clinical Trials Regulation: “Within one year
from the end of a clinical trial… the sponsor shall
submit to the EU database a summary of the
results… It shall be accompanied by a summary
written in a manner that is understandable to
laypersons.”
• Applies to all Phase I – IV interventional trials.
Posting required within 1 year of study completion
(6 months for pediatric trials).
• Guidance in active development for 2018
implementation.

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Lay Summary Program
• Insert information about how the program will be implemented within the
company (timelines, etc.…)
• If there are pilot studies insert that information and the decision why they were
selected.
• If there is a working group within the company working on this could include a
slide of who is who
Overview of Program