1. National Health Council Chief Medical/Scientific Officers Conference
Patient Voice in Trial Design:
Alzheimer’s Disease Simulation Project
National Health Council
Chief Medical/Scientific Officers Conference
September 19, 2017

2. Mock Clinical Trial Simulation Overview
Real physician, real study coordinator, real patents: unscripted/unrehearsed – walk through study visits
Conducted in hospitals in 3 countries (U.S. Netherlands, Spain)
12 patient-informant dyads completed and reported
Each simulation hours
4 patient-informant simulations completed in each market
24 people participated in total
Study site staff included in the simulations:
Study site coordinator (explain study visits)
Physician investigator (explain overall design and key components of study)
Psychologist (administer cognitive assessments)
Research Moderator (pre/post simulation interviews)

3. Clinical Trial Simulation Flow
Step 1 (Trial Naïve): General introduction to the Alzheimer’s trial and screening phase as presented by Study Physician
Step 1 (Previous Study Participants/Informants): Debrief
Step 2: Cognitive assessments administered by trained rater (Ph.D.)
Step 3: Study Physician returns to respond review treatment and follow-up phase
Step 4: Question and answer session with patient, informant and study physician and/or study coordinator (Ph.D.)
Step 5: Debrief interview with research moderator to elicit additional feedback about the trial (e.g., burden, confusion, study visits, overall interest)

4. Key Findings Considerable differences by site & country
Caregivers play an instrumental role in patient recruitment and retention
Involve IRBs/ECs and legal, compliance, regulatory, and privacy as early as possible
Procedural tests (CSF, MRI/PET) perceived as most difficult part of study
“Clustering” appointments (e.g., dermatologist, eye exam) appreciated to reduce time
Concerns/anxiety around testing positive for amyloid; relief being in trial/taking action
Psychological assessments caused concern and anxiety
Need for and importance of study staff rapport, particularly the neuropsychologist
Participants requested/appreciated detailed, laymen’s explanations about Alzheimer’s
Barriers to participation: placebo for 4.5 years; number of visits; number of tests
Monitoring perceived as form of intervention e.g., “doing something” in case study drug “wasn’t working”