Chain Event: Intro - Sean Manion
- 1. Blockchain & Health Science Research Symposium Chain Event: Georgetown – 12 May 2018 Sean T Manion PhD CEO, Science Distributed Vice President, American College of Military Public Health
- 2. Blockchain: Distributed Science Value Proposition ▪ Better Science (for Scientists) ▪ Problem: Reproducibility Issues ▪ 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 ▪ Solution: Increased return on investment for research dollars spent; reduced data management costs through blockchain/smart contracts, amplified with machine learning/AI ▪ Faster Miracles (for Everyone) ▪ Problem: 17 years from bench to bedside ▪ Solution: Faster from bench to bedside: improved outcomes, accelerated research and higher quality data; improved tracking of individual researcher contribution will allow for expanded permissioned access of data; assisting with administrative applications for blockchain (e.g. IRB file process)
- 3. Enhancing Federal Research: Traumatic Brain Injury & Blockchain Technology By Sean Manion - March 3, 2018 http://www.fedhealthit.com/2018/03/enhancing-federal-research-traumatic-brain-injury-blockchain-technology-part-1-introduction/
- 4. https://www.fosteropenscience.eu/ Where Blockchain Can Be Applied to Research
- 5. My Background ▪ Academia (Neuroscience) ▪ 13 years ▪ Economics, Biochemistry (BS), Psychology, Psychiatry, Neuroscience (PhD) ▪ Temple University, Uniformed Services University of the Health Sciences, DoD, NIH ▪ Government Research Administration (Bureauscience) ▪ 8 years ▪ Deputy Chief of Staff, Research Activities Chief ▪ Defense & Veterans Brain Injury Center, w/ DoD, VA, ED, HHS (NIH, CDC, FDA) ▪ 17 sites, 60+ clinical studies, 100+ clinical researchers, 300+ publications ▪ Startup – Science Distributed (Platform for Scientists, Blockchain for Trust) ▪ < 1 year (feels like a lot more)
- 6. Traumatic Brain Injury (TBI): Problem Area • In 2013, about 2.8 million TBI-related emergency department (ED) visits, hospitalizations, and deaths occurred in the United States. • TBI contributed to the deaths of nearly 50,000 people. • TBI was a diagnosis in more than 282,000 hospitalizations and 2.5 million ED visits. These consisted of TBI alone or TBI in combination with other injuries. • In 2012, an estimated 329,290 children (age 19 or younger) were treated in U.S. EDs for sports and recreation-related injuries that included a diagnosis of concussion or TBI. • From 2001 to 2012, the rate of ED visits for sports and recreation-related injuries with a diagnosis of concussion or TBI, alone or in combination with other injuries, more than doubled among children (age 19 or younger). https://www.cdc.gov/traumaticbraininjury/get_the_facts.html
- 7. Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System ▪ FITBIR was developed to share data across the entire TBI research field ▪ Created in Jan 2013 by NIH, DoD ▪ 25 federal agencies partnered: NIH, DoD, and VA; along with One Mind ▪ Hosted by NIH (fitbir.nih.gov) ▪ Central repository for data ▪ Encourages data sharing, cross- study comparison, and meta- analysis
- 8. TBI: Federal Research ▪ NIH – 665 active studies; $307 Million (2018, NIH RePORTER) ▪ DoD - ~300 active studies (est.); ~$200 Million annually (est.*) * “Report to Congress: On Expenditures for Activities on Traumatic Brain Injury and Psychological Health, Including Posttraumatic Stress Disorder, for Calendar Year 2012” ▪ VA – 171 active studies (2018, NIH RePORTER) ▪ Fed TBI Research – 1,000+ studies; $500+ Million annually ▪ Studies in FITBIR (https://fitbir.nih.gov/content/submitted-data) ▪ 125 studies committed to contribute data ▪ 78 studies submitted some data ▪ 15 studies have made data available of more than 1000 federally funded TBI studies
- 9. https://www.fosteropenscience.eu/ Where Blockchain Can Be Applied to Research
- 10. FITBIR Challenges ▪ Researchers concerned with sharing data; “being scooped” ▪ Limitations with tracking individual researcher contribution ▪ Costly for research groups to format data ▪ Limitations of centralized data quality control ▪ Centralized access to data slow ▪ Identity of requestors ▪ Regulatory approval ▪ Limited number of Common Data Elements (CDE) ▪ CDEs took 5+years to standardize by federal CDE working group ▪ Additional data elements challenging to add/standardize ▪ Limitations of centralized staff to approve new CDEs
- 11. How Blockchain Can Help ▪ Expanded data contribution tracking for individual researchers ▪ Auditable record of use of data by other researchers ▪ Data formatting automated by smart contracts ▪ Identity of users verifiable; automated speeding access ▪ Confirmation of regulatory approvals automated ▪ Consensus for additional data elements to facilitate expanded data elements ▪ Consensus for new standards driven by protocol development with experts and facilitated by automation/smart contracts and assistance by AI analysis of available literature
- 12. General Challenges for Blockchain in Federal Research • Administrators are risk averse • Regulators are wary of the unknown • Acquisition standards matter • Researchers are complex • Science is a complex system • Layered incentives; $$ only one • Want input on protocols • Developers assume simple, clean data • Research data is messy, non-standardized • Research partially centralized/distributed • Central and single node intermediaries **Average federal scientist/ administrator perception on blockchain for research
- 13. Next Steps For Administrators: Engage health regulators; sandbox approach successful in the UK Educate key stakeholders on the technology and processes For Researchers: Create networks of early adopters Convene standards committees in key health areas For Developers: Use UX design methodology to develop pilot governance protocol Understand complexities of health and research data
- 14. Questions – Comments – Future Follow Up Blockchain Healthcare Situation Report (BC/HC SITREP) ▪ Free weekly newsletter; curated news & events w/ commentary ▪ Email stmanion@gmail.com w/ “BC/HC SITREP” in subject line Blockchain Health Science Research Symposium – Georgetown, 12 May 2018 ▪ Blockchain overview and use case for academic and government researchers ▪ Free, invite only, limited space, researchers prioritized ▪ Email stmanion@gmail.com and kibourque@loyola.edu w/ CV/resume Science Distributed Pilot Blockchain – in development ▪ Network, protocol, blockchain; in that order ▪ Email stmanion@gmail.com w/ statement of interest
- 16. Science will be Blockchained by 2025 Sean Manion - Published on January 16, 2017 (LinkedIn Pulse) https://www.linkedin.com/pulse/science-blockchained-2025-sean-manion
- 17. U.S. Investments in Medical and Health Research and Development (2015) ▪ Worldwide $2.5 trillion annually on scientific R&D (data.oecd.org) ▪ Total U.S. medical and health R&D was $158.7 billion. “U.S. Investments in Medical and Health Research and Development, 2013 – 2015,” Research America! ▪ !!!!! U.S. biomedical research that can’t be replicated - $28 Billion per year !!!!!! “Economics of reproducibility in Preclinical Research” Freedman et al, PLoS 13(6) e1002165, 2015 ▪ What amount of clinical research can’t be replicated?
- 18. U.S. Investments in Medical and Health Research and Development (2015) Breakdown by source: ▪ Industry invested more in R&D than any other sector, totaling $102.7 billion. ▪ Federal agencies invested a total of $35.9 billion, with the National Institutes of Health accounting for $29.6 billion. ▪ Research institutions, including universities and independent research institutes (IRIs), dedicated more than $12.5 billion to R&D. ▪ Foundations contributed $4.7 billion to U.S. medical and health R&D. ▪ Voluntary health associations, professional societies, and state and local governments invested nearly $3 billion in medical and health R&D.
- 19. Levels of Evidence for Clinical Practice