Plain Language Summary Roadshow Educational Material Agenda Vision Overview of Plain Language Summary Plain Language Summary Program Vision ltInsert Company Visiongt Overview of Lay Patient Summary ID: 653362
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Slide1
<Date> <Location>
Plain Language Summary Roadshow
(Educational Material)Slide2
Agenda
Vision
Overview
of
Plain Language Summary
Plain Language Summary ProgramSlide3
Vision
<Insert Company Vision>Slide4
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 6
th
– 8
th
grade level Main elements:“Thank You” to participants and recognition of their participation in the studyAn overview of the clinical trial based on information contained in clinical study protocol.A discussion of study results directly reflecting technical findings in the clinical study report
Plain Language SummarySlide5
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 Slide6
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
“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
“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.
Slide7
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
.Slide8
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