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

2. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 1
Agenda
• Vision
• Overview of Plain Language Summary
• Plain Language Summary Program

3. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 2
Vision
<Insert Company Vision>

4. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 3
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

5. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 4
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

6. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 5
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.

7. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 6
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.

8. Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 7
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