openclinica europe 2015 - keynote
TRANSCRIPT
we’re trying to change the nature of research.
undersized, underpowered, exclusionary,
wasteful.
http://www.zmescience.com/medicine/mind-and-brain/man-feel-invisible-24042015/
1.
the odds of successful conversion to wisdom go up as more people can see the
data.
accuracy of model jumped three orders of magnitude in nine days.
12
76% accurate.
people are starting to get medical data outside
the medical-research industrial complex
people are starting to get medical data outside the context of regulation
and bioethics.
2.
the Bridge project.
from 1800 to 100,000
689,003 people
written by a doctor edited by a lawyer re-edited by a committee
presented to a participant for zero-sum game
written by a doctor edited by a lawyer re-edited by a committee
presented to a participant for zero-sum game
comprehension language time format
regulatory liability
3.
informed consent in a mobile context?
1. series of interviews and requirements gathering
2. interaction design process and prototyping
3. consent development
courtesy of: David Fore
relatively low risk observational study
primary risk is to privacy
gait balance voice tapping
1. tiered information access by participants
2. “pictorial” dominant on first information tier
3. text dominant on second information tier
4. require perfect score on short assessment
initial metaphor
41
force the conversation every time:
what must a participant understand to provide informed consent?
43
mPower (Parkinsons Disease)
Share the Journey (Breast Cancer Survivor)
45
46
post-consent, pre-enrollment:
assessment (must get all 5 right)
archives and ongoing engagement
emailed to participant
also available in-app
changeable by participant
iconographic representations of key concepts in informed consent
open source methods
design layouts
workflows
web templates and assets
4.
next: close the loop to the patient.
76
“virtual tumor boards”
consent isn’t standalone. it connects to ethics and governance structures inside data use - and back.
