improving health through collaboration, organizational culture, and openness … · 2019-05-21 ·...

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

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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

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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)?

Greg Biggersgreg@gregbiggers.com

@bigs

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Greg Biggersgreg@genomera.com@bigs

Appendix

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 Biggersgreg@genomera.com

@bigs

Testimony to U.S. Presidential Bioethics Commission:

http://j.mp/PresBioethics

(Traditional) Clinical Trials

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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

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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.