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Enhancing Patient Experience in Clinical Studies

Engage in discussions to improve patient experiences in clinical studies. Learn about study details and provide valuable feedback. Join us on <Enter Date> at <Enter Location>.

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Enhancing Patient Experience in Clinical Studies

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  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. <Enter Study Details>Patient Advisory Board (PAB) <Enter Date> <enter sponsor information> <enter location>

  2. Welcome! Initiative Team Patient Advisory Board (PAB) Participants • Enter names Sponsor Team • Enter names Vendor Team • Enter names

  3. (Icebreaker Activity)Please Share Your Experiences • Over the next 2 minutes, write down words and/or draw pictures on your worksheet that describe your experiences with (add disease). • Select a few words or pictures from your worksheet and please describe them to the group.

  4. What We’d Like To Talk About Today This slide is a sample. Replace this slide with sponsor specific agenda.

  5. What We’d Like To Talk About Today This slide is a sample. Replace this slide with sponsor specific agenda.

  6. What Is TransCelerate and Who Is the Patient Experience Team? This slide is a sample. Replace this slide with sponsor specific details.

  7. 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 Studies Optional: Learn more about TransCelerate’s Patient Initiatives https://youtu.be/_7NTeQsPXEQ 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 • To improve engagement and partnership between biopharmaceutical companies and patients to create better experiences for clinical study participants, caregivers, and families VISION Develop better understanding of how… Schedule of Activities Procedures& Assessments Study Design ScientificObjectives Biopharmaceutical Companies, Sites, Study Doctors Translates into… Reduced Patient Burden Perception of Value Willingness toParticipate PatientEmpowerment This slide is an overview of the TransCelerate Patient Experience Initiative. Replace this slide with sponsor specific introductory material. Diverse Patient Populations

  9. What Do We Want to Do Today?

  10. Today We Want To… Learn about Clinical Studies and the <enter sponsor team details – e.g., study team or Patient Experience team…> Learn about the “sample”<enter study details> clinical study Talk with each other and the team and share thoughts and ideas about the study

  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. 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.

  13. How We Will Share Details About The Trial and Obtain Your Feedback For each part of the trial, we will talk about: 3 1 2 DISCUSSION Questions for you. For example: How do you think this part of the trial might affect study participants’ experiences? 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. • As we talk, please feel to write down any notes in your worksheet • All your comments will be kept confidential This slide is a sample. Replace this slide with sponsor study specific details.

  14. Throughout The Day… • Write down your questions and comments This slide is a sample of how to keep the audience engaged throughout the day. Replace this slide with sponsor study specific asks/activities.

  15. What Is a Clinical Trial?

  16. Clinical Trials 101 • 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: https://www.youtube.com/watch?v=6B5S3-nTdD4 Source: http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf

  17. 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 (4) (2) (1) (3) • See if treatment is safe for humans • First time testing in a small group • Determines tolerable dose levels Is the treatment safe? • Further evaluate safety/side effects • Given to a wider group of patients • Test one or more dose levels for effectiveness Does the treatment work? • 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? • 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: https://www.fda.gov/ForPatients/Approvals/Drugs/default.htm • Glossary of Terms from FDA.gov: https://www.fda.gov/ForPatients/ucm410359.htm • EMA Drug Development Process:http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000489.jsp

  18. Break 15 minutes

  19. What Is the <enter study details>Clinical Study?

  20. Today We Will Discuss AClinical Studyin <enter the disease> • <Provide description of study and approximate timeline when patient input is being requested?

  21. Here Is A Quick Summary Of The Sample Study: • The goal is to find out if a study drug can help people with enter the disease • Enter key elements of the study in few bullets This is a Phase 3 sample study

  22. What Is the Sample Study Measuring and How?: Study Objectives and Endpoints

  23. Study Objectives and Endpoints DEFINITION 1 Objectives: What the study is testing • “Primary” Objective = • The most important objective. • Others are “Secondary” and “Exploratory.” Endpoints: How the study will measure what it is testing • An endpoint is something that is measured to check if an objective was met This slide is a sample. Replace this slide with sponsor specific definition.

  24. Primary Objective and Endpoints Sample 2 • Endpoints: • How the study will measure what it is testing • Objectives: • What the study is testing Primary: • To confirm the clinical efficacy of XXXX Primary: Enter below in few bullets primary objective in a comprehensive language for patients This slide is a sample. Replace this slide with sponsor study specific details.

  25. Secondary Objectives and Endpoints Sample 2 Endpoints: How the study will measure what it is testing Objectives: What the study is testing Secondary: • To assess the clinical efficacy of XXX Secondary: Enter below in few bullets secondary objective in a comprehensive language for patients Enter below in few bullets secondary objective in a comprehensive language for patients • To assess the safety ofXXX • To assess XXX Enter below in few bullets secondary objective in a comprehensive language for patients This slide is a sample. Replace this slide with sponsor study specific details.

  26. Exploratory Objectives and Endpoints Sample 2 Endpoints: How the study will measure what it is testing Objectives: What the study is testing Exploratory: • To assess XXXX Exploratory: Enter below in few bullets exploratory objective in a comprehensive language for patients This slide is a sample. Replace this slide with sponsor study specific details.

  27. Exploratory Objectives and Endpoints: Patient Reported Outcomes (i.e. Health Questionnaires) • Sample 1: add here the Questionnaires /scales used • Sample 2: add here the Questionnaires /scales used • Sample 3: add here the Questionnaires /scales used • … This slide is a sample. Replace this slide with sponsor study specific examples/asks.

  28. What Do You Think About The Sample Patient-Reported Outcomes (PROs)? 5 Over the next 5 to 10 minutes, please read through the PROs in the worksheet. Independent exercise: • For each PRO, write down a number 1-5 to indicate how important these items are to you 1 = least important 3 = neutral 5 = most important • Mark () the 3 “best” PROs that ask about things you care about most Please share your thoughts with the group. This slide is a sample. Replace this slide with sponsor specific activity details/asks.

  29. Study Objectives and Endpoints DISCUSSION 3 • What do you think about the sample PROs? What did you mark as the 3 “best” PROs that ask about things you care about most? • Thinking about your experiences with lupus, what are your wellness goals? Do these generally match what the study is assessing? • The primary (most important) objective of the study is based on the BILAG and SLEDAI. If you were considering a new treatment, how much would you care about seeing these study results? • Are there other symptoms or other things about your condition that are more important to you? This slide is a sample. Replace this slide with sponsor specific questions.

  30. What Is the Sample Study Measuring and How?: Study Design

  31. Study Design DEFINITION 1 • The study design is how the study is set up to test the primary objective • This study is testing XXXX compared to XXX. • This study is randomized and double-blind/Open label : add simple definition • Randomized means that like a flip of a coin the medication will be assigned to you • Double-blind means neither you nor your study doctor will know what medication you are taking • XXXpatients will be randomized in the study • Each patient will be in the study for up to XXX weeks This slide is a sample. Replace this slide with sponsor specific definition.

  32. Study Design Sample 2 Double-blind Treatment Period (XX weeks) Safety Follow-up (XX weeks after last dose) Open-Label Extension Screening Period (1-14 days) Consent: A patient considers if they want to participate in a study. If so, they sign the informed consent form. This starts the patient’s participation in the study. Randomization: After the patient qualifies for the study, the patient is assigned to a treatment group by chance (like picking a number out of a hat or flipping a coin) XXX XX mg Every Week (XXX patients) Safety Follow-up and Open-Label Extension: Study activities to check in with the patient to find out if they have had any side effects or others events happen Screening: Study activities to see if a patient qualifies for the study • XXX • XX mg • Every Week • (XXX patients) • XXX • XX mg • Every Week • (XXX patients) *Open Label – the patient and sponsor are aware of the treatment group This slide is a sample. Replace this slide with sponsor study specific details.

  33. Study Design Sample 2 Double-blind Treatment Period (XX weeks) Safety Follow-up (XX weeks after last dose) Open-Label Extension Safety Follow-up and Open-Label Extension • Participants can still use corticosteroids and some antimalarials and immunosuppressants during the study • Participants could reduce oral corticosteroid use after the first 4 weeks of the study, with the study doctor’s supervision • Study drug and XXX are given oral/intravenously ?, frequency,study visits are add frequency Screening Period (1-14 days) Screening XXX XXX mg, or XXXX Consent Randomization This slide is a sample. Replace this slide with sponsor study specific details.

  34. Study Design DISCUSSION 3 • What aspects of the study design might make you not want to join the study? • What aspects of the study design might make you want to not stay in the study? • What do you think about a 33% chance to be assigned to placebo? • How do you feel on XXXX • If you could change one aspect of the overall study design, what would it be? This slide is a sample. Replace this slide with sponsor specific questions.

  35. What Is the Sample Study Measuring and How?: Study Treatments

  36. Study Treatments DEFINITION 1 • Study treatments are the drugs that are given in the study • A study treatment can be: • The test drug – It is being studied and is not yet approved by a health authority for the condition • A placebo – An inactive substance that looks like the other study treatments but has no effect on the condition, like a “sugar pill” • The study participants take the study treatment over a certain period of time (treatment period) This slide is a sample. Replace this slide with sponsor specific questions.

  37. Study Treatments Sample 2 • Study treatment is given byXXX • Each infusion takes XX minutes • Frequency • Study drug duration for the entire study duration • * If study medication will be given in conjunction with standard of care this should be depicted in your visual aid XXXX - XXXmg OR + Randomization XXXX XX mg Placebo OR This slide is a sample. Replace this slide with sponsor study specific details. Placebo

  38. Infusions Are Every Week For XX Weeks Over XX Week Treatment Cycles: Sample 2 XX total infusions over ~1 year This slide is a sample. Replace this slide with sponsor study specific details.

  39. Study Treatments DISCUSSION 3 • What aspects of the study treatments might cause people to not want to join the study, stay in the study, or receive all treatments as scheduled? • How do you feel about intravenous infusions and the # of infusions? • How do you feel about the length of time the infusion will take? • What do you think about the possibility of lowering the dose of XXXduring the study? • If you could change one aspect of the study treatments, what would it be and why? This slide is a sample. Replace this slide with sponsor specific questions.

  40. Lunch Break 60 minutes

  41. Who Can be Included in the Sample Study?: Eligibility Criteria

  42. Eligibility Criteria DEFINITION 1 • Eligibility criteria are “rules” about the types of people who can enter a study. The same rules are applied to everyone and are based on factors like age, medical & psychological conditions, and medications taken. • “Inclusion criteria" = OK to enter study • “Exclusioncriteria” = Not OK to enter study • It’s important to let many different types of people into a study so that we can better know how the drug will work for them. However, the rules are needed for a study so that people don’t get into the study who: • Are likely to be harmed by the study drug or are unlikely to be helped by the study drug • Have other conditions or symptoms or are taking treatments that would make it hard to know how the study drug is working This slide is a sample. Replace this slide with sponsor specific definitions.

  43. Eligibility Criteria Sample 2 • Inclusion Criteria: • XXX • XXX • Exclusion Criteria: • XXX • XXX This slide is a sample. Replace this slide with sponsor study specific details (approx. 5 to 6 bullets per criteria).

  44. Excluded Medications (Medications That Cannot Be Taken During the Study) Sample 2 “Medication” is listed as the generic name (brand name) Class XX “Washout Period” is the time before the first study treatment infusion that the medication cannot be used Class XX Others This slide is a sample. Replace this slide with sponsor study specific details.

  45. Eligibility Criteria DISCUSSION 3 What do you think about the inclusion and exclusion criteria for this study? • Do you think these criteria overall would stop too many people from joining the study? • Which criteria would make most people not be able to join the study? • If you could change one part of the criteria, what would it be? This slide is a sample. Replace this slide with sponsor specific questions.

  46. What Will Study Participants Experience?

  47. The Study – Who, What, Where, When, How, How Long? DEFINITION 1 Who? The patient participates in the study according to a study calendar, known as a Schedule of Activities (SOA) What? The SOA lays out what will happen in the study Where? The SOA tells what will happen during a study visit (usually at a study site) When? The SOA lays out when each thing will happen How? The SOA tells how something will be measured How Long? The SOA tells how long the whole study could take This slide is a sample. Replace this slide with sponsor specific details.

  48. Schedule of Activities Sample 2 This slide is a sample. Replace this slide with sponsor study specific details.

  49. Study Visits DISCUSSION 3 The study would last for about a year and include 27 visits. Do you have any concerns or comments on this? What support might you need (such as transportation to the site, childcare arrangements, adult care arrangements, other)? Would it make a difference if any of the parts of the visits could be done instead by: • having a healthcare professional visit you at home? • visiting a local pharmacy? • computer or phone? This slide is a sample. Replace this slide with sponsor specific questions.

  50. Break 10 minutes

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