Patient and Public Involvement(PPI) andPharmaceutical Development Through Open
Innovation Processes: Recent Activities
Kotone Matsuyama,Professor, Department of Health Policy and Management, Nippon MedicalSchoolCo-Authors;
Naoki Tsutsumi, Keiko Inoue, Noriko Iwaya, Kyoko Imamura

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Contents• Introduction~History of Patient Engagement• Patient and Public Involvement during the COVID-19 Pandemic• Changes in the Clinical Trial Environment During the COVID-19
Pandemic• Patient Engagement, working toward localization• Conclusion

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Ethical Innovation for Global Health Webinar

2Introduction: “Patient Public Engagement”• AIDS Coalition to Unleash Power (ACTUP) is aninternational, grassroots political group
working to end the AIDS pandemic. Thegroup works to improve the livesof people with AIDS through direct
action, medical research, treatment
and advocacy, and working to change
legislation and public policies.
• ACT UP was formed on March 12, 1987,
at the Lesbian and Gay Community
Services Center in New York City.
• Larry Kramer was asked to speak aspart of a rotating speaker series, andhis well-attended speech focused onaction to fight AIDS.
https://en.wikipedia.org/wiki/ACT_UP
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FDA activities…

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https://www.fda.gov/patients/evolution-patientengagement-fda

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Patient and Public Involvement during the COVID-19 Pandemic
Decentralized Clinical Trial
https://florencehc.com/blog-post/decentralized-clinical-trialswhat-the-future-holds/

Traditional Clinical Trial
Decentralized Clinical Trial

Virtual Clinical Trial
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6An example to collect PRO data of COVID-19 aftereffects
https://prtimes.jp/main/html/rd/p/000000043.000036622.html

Prof. Satoshi Kutsuna, Osaka university

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DeTap Trial

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Sarraju, A., Seninger, C., Parameswaran, V. et al. Pandemicproof recruitment and engagement in a fully decentralized trial
in atrial fibrillation patients (DeTAP). npj Digit. Med. 5, 80(2022). https://doi.org/10.1038/s41746-022-00622-9

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8DeTap trial Design

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9Limitation• Our study had certain limitations. The majority of our participants
were White and urban dwelling, and nearly 70% of our population
had bachelor’s degrees or higher levels of education, which limits
the generalizability of our findings. Future efforts should develop andvalidate decentralized protocols in more diverse populations toensure that the use of digital technologies does not exacerbate
existing health inequities. Adapting recruitment strategies to focus
on participant diversity as a key trial metric may help address thisgoal. OAC adherence was fully self-reported and was not validated
objectively by study investigators.

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EUPATI; European Patient Academy

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Clinical Trial Ambassador, using EUPATI training material(Austria, Japan)
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Orientation for representative ofPatient Organizations
27- 28 July 2022 – virtualHands-on Training • Introduction about project overview 2022
• Introduction about the training contents
Where to find Clinical
Trials information?

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Oct 2022 – virtual• Locking back the training and discussion
at initial training• Training and Demonstrations
 how to access clinical trialinformation• Discussing any specific future initiatives
 What you or your patientorganization can do based onwhat you learned

4Workshop Wrap up about theAmbassador roleNov 2022 – virtual• Review of initial training and hands-on
training• Discussion
 What you learned and practiced inthe Clinical Trial Ambassador
project What do they need in addition toplanned training?

2 Initial Training

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31 Aug 2022 – virtual• Looking back discussion about Ambassadors role in 2021
• Providing initial training Overview on drug development process, Clinical Trials• Discussing the needs of access to clinical trial information
 What information do you (or others in your patient organization) want about clinical
trials?
Ethical Innovation for Global Health Webinar• Input any specific initiatives for the future12Localization; JI4PE A~E course

JI4PE each educational course
Human Resource Development for
Patient Citizens (A), for Patient
Organization Leaders (B)Ethics Committee Member Training (E)is mainly for patients and patient
supporters.
Currently, people having patient
background are challenging course C(Pharmaceutical Medicine Training)2023/12/6

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Co-creation new therapies with Patient and Public
I received a very
detailed lectureon the mechanismof clinical trials
and related
knowledge. I hopethat more people
will have a goodunderstanding ofclinical trials.

I thought it was anunprecedented activity.
I am glad that the project
was an activity thatinvolved multiple
stakeholders and allowed
for interactive
discussions with patientsand companies!

We hope that thesuccess of our clinical
trial ambassadors will
increase the number ofparticipants in clinical
trials and bring better
drugs to the market
faster.
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I hope that byinforming people
who don't know
about the clinical
trial, I can dispel
their fears.

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Patient Engagement; What‘s next?
 It includes people across organizations who
have expertise in supporting the quality of lifeof patients and citizens.
 The purpose of the activities is to bemeaningful to all involved.
 It provides a venue and resources for mutual
learning, rather than simply making a request
or offering support to someone else involved.
 It seeks to understand, propose, and realize
together in order to achieve the desired
results for all involved.
 They plan so that many people can takeadvantage of the results.
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Special Present for you!
• Widmung, Myrthen, Schumann

You my soul, you my heart,
you my bliss, O you my pain,
you my world in which I live,my heaven, thou into which I float,
O thou my grave, into which
I eternally gave my sorrow!
You are rest, you are peace,thou art my heaven.
That you love me makes me worthy,Your gaze has transfigured me before me,
You lift me lovingly above myself,
my good spirit, my better self!

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Tomoaki Yokoyama,composer, pianist
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