From Patient to Participant:

The Evolving Role of

Consumers in Research

Natasha F. Bonhomme

Genetic Alliance Network

• Disease Advocacy Orgs

• General Support Orgs

• Universities • Government

• Companies • Labs

• Hospitals

• Health Centers • Professional Societies

• Think tanks/policy groups

Network of Resources

Maturing Patient Advocacy • 1950s-1960s – Medical Models

‣ Voluntary Health Agencies

• 1970s – Nascent Patient Movement – Missing Services

‣ Self-organized Disease Specific Organizations

• 1980s – Maturing Patient Movement – IS & IT Technology ‣ New Alliances and New Strategies Emerge

• 1990s – Powerful Momentum “Patient Power” – Websites & Email ‣ Institutionalized Advocacy Coalitions ‣ Patient Organized Networked Research Organizations ‣ Effecting Broad Change of Public Policy

• 2000s – Successful Models “Research Advocacy” – BioBanks ‣ Active Engagement in the Research Enterprise ‣ Breaking Conventional Boundaries of the Medical Model ‣ Demand for Quality, Services, Choice, & Personalized Delivery ‣ Patient Rights Public Policy – Changing the Status-Quo

• 2010s – Networks in the Commons – Translation & Delivery

What Do Groups Do in Research?

• Set research initiatives

• Raise funds for investigators – Becoming investigators

• Sponsor projects – Academic and Biotech

• IRB

• Collect data (registries and biobanks)

• Recruit

• Communicate out messages

• Disseminate findings

What do personal data collection tools look like in 2015?

iPhone App

iPhone App

Wireless Scale

Twitter Facebook

What does it mean?

• Self aggregation

• Label =/= experience

• Data and experience even more intertwine

• Can’t have the specimen without the other

“Stuff”

Educate Communicate

Because people seek out what they want to know…

In other industries:

• Co-design

• Consumer testing

• Consumer preference

analysis

• Responsiveness

• Self-reported clinical data

“Enables individuals to set their own

sharing, privacy and data access

preferences, in a granular and dynamic

manner.”

• Community-based guides

• “White label” version

(“Open Consent”)

(similar to Portable Legal Consent)

(similar to HIPAA/Common Rule)

(“Dynamic Consent” model)

(Effectively an Opt-out)

Platform for Engaging Everyone Responsibly (PEER)

... Adjust dynamic and granular settings as values and priorities change over time

PEER Deployed • PCORnet PPRN

– 11 Disease Advocacy Organizations

• Robert Wood Johnson Foundation Project

– 30 Communities/collectives (employers, churches, gyms)

• Campaigns

– Free the Data: https://www.free-the-data.org

– Patient Focused Drug Development (Sickle cell, IBD, IPF)

– Patient Preference Study (CDHR – Obesity)

• Advocacy Initiated

– United Mitochondrial Disease Foundation

– Pancreatic Cancer Action Network

– …

• General Public

– Registries for All: https://www.reg4all.org

– TrialsFinder: https://www.trialsfinder.org

Mosaic: crowd-sourced research

• Bullet

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Advocacy owned and managed data repository and samples

Clinical Information Medical Records

DNA/RNA Self-reported Data

Cell Lines Tissue / Organs

30,000 samples + 20,000 clinical records

BioBank.org

Components of a network-based Learning

Health System*

1. Focus on outcome

2. Build community

3. Effective use of technology

4. Learning system

– System science, QI, qualitative

research, clinical research

*Collective creativity (Swarm Creativity; Peter Gloor) Lead User innovation (Democratizing Innovation; Eric von Hippel) New economic models (The Wealth of Networks; Yochai Benkler) Actor-oriented organizational architecture (Configuring value for competitive advantage; Charles Stabell and Oystein Fjelstad

Courtesy of Peter Margolis, ImproveCareNow PPRN, PCORnet

Biggest Ah-ha(s)!

• Not research “subjects” and are often not

just “patients”

• This is about relationships, not

transactions

• Relationships are messy

• This will be challenging AND fun

It’s about trust

(more so than privacy)

But privacy is a surrogate marker for trust

…it reflects a level of care and if these are not present, people

feel it …which undermines trust

Resources • Community Campus Partnership for Health:

https://ccph.memberclicks.net/

• PCORI Patient and Family Engagement Rubric: http://www.pcori.org/sites/default/files/PCORI-Patient-and-Family-Engagement-Rubric.pdf

• The Center for Information and Study on Clinical Research Participation: https://www.ciscrp.org/

• Research On Medical Practices (ROMP): https://rompethics.iths.org/

• Clinical Trials Transformation Inititiative: http://www.ctti-clinicaltrials.org/

• Community Engagement Studio: https://www.aamc.org/initiatives/rocc/363090/vanderbiltuniversityprojectdescription.html

Thanks!

20

Natasha F, Bonhomme, Sharon F. Terry, MA

nbonhomme@geneticalliance.org

peerplatform.org

geneticalliance.org/PEER

mosaic.ucsf.edu

@geneticalliance

• How do we create a culture of openness and sharing?

• Where can we take friction out of our systems (or lack thereof)?

• How do we animate the American public to get in the game?

• How do we know what is working and what is not?

• How to get complete data on individuals and respect their desire to participate?

• How to get oversight that is flexible enough to deal with these sorts of engagements/development?