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![Blockchain Value Proposition in Research
• Blockchain can be overkill and won’t solve human problems.
• OTOH: If we can do it with existing technology, why aren’t we?
• Blockchain changes the value proposition for tech in research:
• BetterScience(for Scientists)
• Problem: Reproducibility Issues;20% of U.S. health science research can’t be replicated/reproduced*
• Solution: Improved reproducibility through transparency and immutable audit trail for research data; better
quality data from standardization; improved materials; increased meta-analysis capabilities
• Cheaper Research(for Funders)
• Problem: Expensive; decreasing ROI;$30 billion in U.S. health science on non-replicable research*
• Solution: Increased return on investment for research dollars spent; reduced data management costs through
blockchain/smart contracts, amplified with machine learning/AI; cheaper administration
• Faster Miracles (for Everyone)
• Problem: 17 years from bench to bedside; 2-5 years on administrative processes (my estimate)**
• Solution: Faster time from idea to treatment; improved outcomes with accelerated research and higher quality
data; improved tracking of individual contribution allowing for expanded permissioned access of data to more
researchers; faster administrative processes (e.g. IRB, grant review)
* “Economics of reproducibility in Preclinical Research” Freedman et al, PLoS 13(6) e1002165, 2015
** “Enhancing Federal Research: Traumatic Brain Injury & Blockchain Technology - Part 1.5, The Why.” Manion, Feb 2018 https://www.linkedin.com/pulse/enhancing-federal-research-traumatic-brain-
injury-part-sean-manion-1/
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019
3
“Blockchain isn’t hot sauce,
you can’t just put that [stuff]
on everything” – Samson
Williams](https://image.slidesharecdn.com/manionsciencedistributedblockchainhealth-191216170419/75/Blockchain-for-Health-Research-HHS-PCOR-Manion-3-2048.jpg)
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- 1. Blockchain for HealthResearch Sean T Manion, PhD Science Distributed // Blockchain in Healthcare Global (IEEE International Standards & Trade Organization) HHS ASPE Patient Centered Outcomes Research –Trust Fund Webinar 16 December 2019 Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019 1
- 2. Blockchain/Distributed Ledger Technology(DLT) •Blockchain is a distributed ledger of data transactions, exchanges, or events. • Allows a distributed network to automatically maintain a single, virtually immutable record based on an agreed upon governance protocol for consensus. • Can be public, permissioned, or private. Consensus mechanisms will vary. • Tokenization of activity allows for incentivization • Blockchain is not Bitcoin! Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019 2 Example of a financial application of blockchain (By B140970324- Wikimedia Commons) More info: hyperledger.org/ (Hyperledgeris the blockchain arm of the Linux foundation)
- 3. Blockchain Value Propositionin Research • Blockchain can be overkill and won’t solve human problems. • OTOH: If we can do it with existing technology, why aren’t we? • Blockchain changes the value proposition for tech in research: • BetterScience(for Scientists) • Problem: Reproducibility Issues;20% of U.S. health science research can’t be replicated/reproduced* • Solution: Improved reproducibility through transparency and immutable audit trail for research data; better quality data from standardization; improved materials; increased meta-analysis capabilities • Cheaper Research(for Funders) • Problem: Expensive; decreasing ROI;$30 billion in U.S. health science on non-replicable research* • Solution: Increased return on investment for research dollars spent; reduced data management costs through blockchain/smart contracts, amplified with machine learning/AI; cheaper administration • Faster Miracles (for Everyone) • Problem: 17 years from bench to bedside; 2-5 years on administrative processes (my estimate)** • Solution: Faster time from idea to treatment; improved outcomes with accelerated research and higher quality data; improved tracking of individual contribution allowing for expanded permissioned access of data to more researchers; faster administrative processes (e.g. IRB, grant review) * “Economics of reproducibility in Preclinical Research” Freedman et al, PLoS 13(6) e1002165, 2015 ** “Enhancing Federal Research: Traumatic Brain Injury & Blockchain Technology - Part 1.5, The Why.” Manion, Feb 2018 https://www.linkedin.com/pulse/enhancing-federal-research-traumatic-brain- injury-part-sean-manion-1/ Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019 3 “Blockchain isn’t hot sauce, you can’t just put that [stuff] on everything” – Samson Williams
- 4. Blockchain Healthcare Ecosystem KeyUseCases Areas (Examples): • Admin, financial (GSA,Health & Human Services) • Provider identity/credentialing(Professional Credential Exchange; Synaptic Health Alliance) • Medicaldevice tracking(Spiritus Partners,Edinburgh Napier University, Scotland NHS) • Pharma supply chain (FDA: Good Shepherd Pharmacy/Remedichain+; MediLedger/Walmart) • Clinicaltrials (Boehringer Ingelheim, IBM;UCSF*) • *Prototypeof running clinical trials in an untrustworthy environmentusing blockchain. Wong et al. Nature Communications volume10, Article: 917 (2019) • Publishing (Ledger,Blockchainin HealthcareToday, Springer Nature) • ClinicalSupport Tools (Elsevier) • Electronichealth record(Amsys; Rymedi) Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019 4
- 5. FarmtoTable,BenchtoBedside: HealthResearchas DataSupplyChain from “Advancing HealthResearchwithBlockchain” (Manion) in HIMSS textbook Blockchain inHealthcare: Innovations thatEmpower Patients, ConnectProfessionals and ImproveCare Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019 Seed •Crop •Strain •Soil Farm •Plant •Grow •Harvest Processing •Cleaning •Preparation •Packaging Distribution •To consumeror retail •Nextstage processing Table •Restaurant •Retail/Home cooking Idea •Hypothesis •Design •Funding Bench •Research execution •Data Collection •Basic to Clinical Analysis •Hypothesis testing •Statistics •Interpretation Dissemination •Conference presentation •Peer-review publication Bedside •Knowledge translation •Clinical practice guidelines Repeats several times Food Supply Chain • Linear progression • Timeline:< 30 days* • Key variables:type, quantity,quality, variables(e.g. temp) Health ResearchData Supply Chain • Parallel progression • Timeline:2-5yrs (x multiplerepeats) • Key Variables:design, methodology, patient demographics research contribution,statistical approach,outcomes 5
- 6. What are the pre-publication presentations? Whatis the quality or confidence level? How is feedback captured? Gray lit? What are the comments? Are there objective criteria? Crowd-sourced peer review? 7. Publish & Present Are analyses tied to original hypotheses? Are analyses outlined in protocol? Justification of new analyses? Record of attempted analyses? Statistical power? Lit basis of interpretation? Quality of refs? Replicable? Retractions? 6. Analyze & Interpret What are the data standards? Will it be mergeable with other studies? What are the quality assurance steps? Is PHI secure? Is there existing data that can be used? How accessible is the data? What is the ROI for the data? 5. Collect Data Can parts of this process be automated? Will that be faster and more reliable for researchers and regulator? Can multiple IRBs be aligned? Can parts of IRB review be crowdsourced? Can audits be easier? 4. Regulatory Approval Where are funds? Does my plan match programmatic need? Have I applied here before? Why am I filling in all this information again? How is the money being tracked? 3. Get Funding What methods are available? What variations have been developed? Are skilled collaborators available? Where? Are other resources (i.e. space, equipment) available? 2. Plan research What hypotheses have already been tested? By whom? When? What happened? What was the approach? What was the result? Current status? 1. Form Hypotheses Blockchain Questions in Research • Where canthings be improvedineacharea? • Can blockchain/DLTfacilitateand/or incentivize? • What is the cost/benefitof implementation? • If it can be achievedw/oblockchain/DLT, why isn’t it? Questions to consider acrossthe steps in research: Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019 6
- 7. Blockchain, Cloud, &AI/ML Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019 7 Photographyby Lucy Hewett AI/ML Blockchain Cloud
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- 9. Blockchain for DataManagement Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019 9
- 10. The Way Forward fromBlockchain for Medical Research: Accelerating Trust in Healthcare Manion & Bizouati-Kennedy (April 2020, CRC Press) Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Jan 2019 10 Key Areas of Impact Recommendations Sharing ideas/hypotheses Cross-agency,public-private, subject matter working groups Accelerated proposal review University and researchgroup engagement Funding innovations IEEE/NIST standards Protocol development Strategic Planning Enhanced data sharing Administrative pilots Methods and analyses tracking Regulatory engagement Pre-review of interpretations Network research pilots Crowdsourced peer-review Enterprise deployment Fractionalized publishing Distributed Autonomous Organization
- 11. More information • IEEEStandards Association – Standards for Blockchainin Health and Life Sciencesw Research Subgroup: https://standards.ieee.org/project/2418_6.html • Frontiers’Blockchainfor Science – Peer-reviewedscientific journal: https://www.frontiersin.org/journals/blockchain/sections/blockchain-for-science# • HIMSS BlockchainTask Force Library: https://www.himss.org/blockchain-healthcare • HIMSS Textbook – Blockchainin Healthcare: Empower Patients and Improve Care (2019,CRC Press): https://www.crcpress.com/Blockchain-in-Healthcare- Innovations-that-Empower-Patients-Connect-Professionals/Dhillon-Bass-Hooper-Metcalf- Cahana/p/book/9780367031084 • New Book – Blockchainfor Medical Research: Accelerating Trust in Healthcare Manion & Bizouati-Kennedy(April 2020,CRC Press): https://www.crcpress.com/Blockchain-for-Medical-Research-Accelerating-Trust-in-Healthcare/Manion- Bizouati-Kennedy/p/book/9780367347468 Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019