1. Note: All highlighted text and TransCelerate branding should be replaced or removed. This is a sample slide deck to share with your patient advisors in advance to your discussion(s) as appropriate.
Patient-Protocol Engagement Toolkit (P-PET) Patient Advisory Board (PAB) Pre-Read Material
<Enter Date>

2. Table of Contents What is a Clinical Trial?
Who is the team that will meet with us?: An overview of <sponsor>
What we will do on <Enter date>? 3 6 9

3. What is a Clinical Trial?

4. Clinical Trials 101
Source:
Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease.
Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.
Optional: to learn more about clinical trials, view this short video: =6B5S3-nTdD4

5. Clinical Trials 101 – Types and Phases of Trials
Interventional Trial: tests the safety and effectiveness of an active drug, therapy, or treatment
Observational Trial: monitors the health of a group of individuals over time
See if treatment is safe for humans
First time testing in a small group
Determines tolerable dose levels
Is the treatment safe?
(1)
Further evaluate safety/side effects
Given to a wider group of patients
Test one or more dose levels for effectiveness
Does the treatment work?
(2)
Monitor safety/side effects
Looks at effectiveness compared with standard of care or placebo
Note: Placebo (i.e., inactive treatment or “sugar pill”) is used in place of “standard of care”, when no treatment exists
Is it better than what’s already available?
(3)
(4)
Look at safety over time
Involves up to thousands of participants
Continue to look at aspects of the treatment after Health Authority approval
Help researchers learn more about a treatment.
Additional information about clinical trials can be found here:
FDA.gov Drug Development Process:
Glossary of Terms from FDA.gov:
EMA Drug Development Process: 

6. Who Is the Team that Will Meet with Us
Who Is the Team that Will Meet with Us?: An Overview of <enter sponsor details>

7. Optional: Learn more about TransCelerate’s Patient Initiatives
TransCelerate is a Global, Not-For-Profit Entity Created to Foster and Promote Collaboration
TransCelerate’s vision is to improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.
One TransCelerate initiative is focused on improving the Patient Experience in Clinical Stuides
Optional: Learn more about TransCelerate’s Patient Initiatives
This slide is an overview of the TransCelerate Patient Experience Initiative. Replace this slide with sponsor specific introductory material.

8. The TransCelerate Patient Experience Team is Focused on Improving Patients’ Experiences With Clinical Research
VISION
To improve engagement and partnership between biopharmaceutical companies and patients to create better experiences for clinical study participants, caregivers, and families
Develop better understanding of how…
Study Design
Scientific Objectives
Procedures & Assessments
Schedule of Activities
Biopharmaceutical Companies, Sites, Study Doctors
Translates into…
Reduced Patient Burden
Perception of Value
Patient Empowerment
Willingness to Participate
This slide is an overview of the TransCelerate Patient Experience Initiative. Replace this slide with sponsor specific introductory material.
Diverse Patient Populations

9. What We Will Do on <Enter Date>?

10. Our Discussions on <enter date> Will Help <enter discussion objective>
An Example of How the P-PET Might Work: +
This is Jan. She is a researcher helping to design a clinical study for a biopharmaceutical company.
This is Amy. She is a patient who has experienced the condition being researched
Jan in collaboration with a patient engagement moderator/facilitator will use the P-PET to get feedback about the protocol from Amy.
Jan will use the feedback to help improve the design and conduct of the study.
This slide is a sample. Replace this slide with sponsor specific needs.

11. On <enter date of discussion> We Will…
As a “Patient Advisor your role is to meet with the team and provide feedback on the clinical trial.
The feedback you provide, will be used by the team to:
Understand how the <enter study details> could be improved
Assess how the feedback supports our discussions
Improve the <enter study details>

12. Here is a Quick Summary of The Sample Trial:
The goal is to find out if a study drug can help people with moderate to severe systemic lupus erythematosus (SLE)
Looking at 2 different doses of a study drug compared to placebo
The study drug and placebo are given intravenously every week for the first 4 weeks of each of four 12-week cycles (for a total of 48 weeks); study visits are monthly
Participants will be men and women at least 18 years old with moderate to severe SLE
Patients can still use corticosteroids and some antimalarials and immunosuppressants during the study
Patients could reduce oral corticosteroid use after the first 4 weeks of the study, with the study doctor’s supervision
This is a Phase 3 sample trial
This slide is a sample. Replace this slide with sponsor study specific details.

13. How We Will Share Details About The Trial And Obtain Your Feedback.
For each part of the trial, we will talk about: 1 2 3
DEFINITION
Description of that part of the trial
and why it is important
SAMPLE
The information for your review. What is planned for that part of the trial and what can – and can’t – be changed and why.
DISCUSSION
Questions for you.
For example: How do you think this part of the trial might affect study participants’
experiences?
This slide is a sample. Replace this slide with sponsor study specific details.

14. Tentative Agenda For <Enter Date>
<Enter Location>
Discussion Topic
Morning Session*
Welcome & Introductions
Review of pre-read material
Learn about the <Enter Study Name or other details>
Lunch Break (<Enter Time>)
Afternoon Session*
<Enter discussion topic – patient friendly language>
Summary of what we all heard and what the team plans to do next
*Breaks will be scheduled throughout the day <Ensure to plan and communicate break times in advance>

15. Thank you!
Visit us, for more information: Watch our “About Us” Video Sign up for our Newsletter, Accelerate to Innovate
This slide is a sample. Replace this slide with sponsor specific closing material.
TransCelerate
BioPharma Inc.
@TransCelerate