improving health through collaboration, organizational culture, and openness … · 2019-05-21 ·...
TRANSCRIPT
Participant-driven health studies and clinical trials
Improving health through collaboration, organizational culture, and openness
@bigsGreg Biggers
Participant-centric registry across all diseases
Ideas Questions
Pharma / MedTech Economics
NIH & Foundation Funding
Slow Drip of Discovery
Expensive Slow Studies
Expensive Slow Bottleneck
2
Consumer: My questions are not being answerd
Discovery & Efficiency Unleashed
Ideas Questions
Efficient, Rigorous, Scalable Studies
Grow Study Organizers
Grow Participants
Participant-Driven Studies for All of Health
Surgical OutcomeDiet & NutritionTherapy EffectivenessBiomarker DiscoveryFact-Check PharmaFitness
Perpetual Phase IV Trials GenomicsRare DiseaseChronic DiseaseSleepAging
Participant-driven health studies and clinical trials
Participant-centric registry across all diseases
Missing our most valuable resource:
PEOPLE and their DATA
Needles and Haystacks
8
9
But the Haystack is Made of Needles
• Privacy• Sharing• Governance• Dynamic Consent• ENGAGEMENT & CONTROL
Participant-Centric:
n = they !! Tradition
n = me !! Quantified Self
n = we !! Our Future
• Unwitting subject• Willing subject• Participant• Collaborator• Shareholder
Who is ‘scientist?’
Enlarging ‘Patient’ Roles
“In the 90s, patients were occasionally invited to the table. Today, we often control the table.”
• CONTROL (of data, tissue, intent, outcomes)
• Communities of TRUST (consent —> governance)
• ENGAGEMENT (bi-di communication, new roles)
• IMPACT (what is at stake?)
• SHAREHOLDERS (in risks & benefits)
• EXPRESS rights (not just protection)
What do individuals want (have)?
Common Data Elements
Disease Specific Data Elements
Gamified Survey
Engagement Education
Trust
Control 17
Individuals Entering the Health Information Highway
2 Sides of Needy CommunityConsumers demand:
• Answers• Speed• Engagement
Researchers need:
• Efficiency• Speed• Participants• Data
HealthData Sharing
+Social
ScientificEvidence
Participant-Driven Health Studies & Clinical Trials
For more:
Presidential Bioethics Commission Testimony on Participant-Driven Research:
http://j.mp/PresBioethics
• Study Design• Recruitment• Enrollment / Consent• Protocol Tracking• Data Collection
Device-reported dataLab-reported dataApp-reported dataUser-reported data
• Participant EngagementUser profilePersonal view of studies‘Return’ of resultsData ownership
• Re-enrollment
Online Clinical Studies Platform
“The best way to predict the future is to invent it”
– Alan Kay
“You never change things by fighting existing reality. To change something, build a new model that makes the existing model obsolete.”
– Buckminster Fuller
“The future is already here.It’s just not evenly distributed yet”
–William Gibson
HealthData
Sharing+Social
ScientificEvidence
Greg [email protected]
@bigs
Testimony to U.S. Presidential Bioethics Commission:
http://j.mp/PresBioethics
(Traditional) Clinical Trials
27
4,000 Experimental new drugs in development70,000Clinical research studies in progress$100BSpent in 2008 on clinical research (at 7% growth)$10,000 Recruiting cost / trial enrollee (avg)85% Human trials delayed by patient enrollment$2.5B Spent on patient recruitment (15% annual growth)
Dr. Cliff Mintz, Life Science Leader Magazine, Nov 2010
28
Rare Disease showing the way30M people in U.S.10% Global Population
7,000 rare diseases. Only 225 have treatments.
Asking for data-based approach in addition to online support groups
Sharing data, testing hypotheses are how they are finding breakthroughs
Proprietary & Confidential Material. DO NOT FORWARD. Copyright © 2012 Genomera, Inc.