National Health Council Chief Medical/Scientific Officers Conference

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Presentation transcript:

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

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 4.5-5 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)

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)

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”