Steps to Overcome Information Overlaod in Clincial Research
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Clinical research is becoming more complex, costly, and inefficient due to a lack of standardized information sharing between sponsors, CROs, and sites. This document outlines opportunities to create a more modern clinical network through unified technology strategies, common data standards and definitions, and measuring success based on the extent of electronic information exchange over time. Key priorities include streamlining information exchange methods, integrating disparate applications, and tracking industry progress in domains like sending, receiving, finding, and integrating clinical trial information across organizations.
Steps to Overcome Information Overlaod in Clincial Research
- 1. Steps to Overcome Information Overload in Clinical Research
- 2. 2Copyright © Veeva Systems 2019 Jason Methia vice president, site strategy jason.methia@veeva.com 617-645-0230 https://www.linkedin.com/in/jasonmethia Veeva Systems
- 3. 3Copyright © Veeva Systems 2019 Lessons Learned from EHR Challenge shifting from digitizing to sharing 2009 EHR stimulus passed (12% EHR adoption) 2015 96% EHR adoption Medicare Access and CHIP Reauthorization Act (MACRA) 2019 Apple allows any health systems to register directly2016 21st Century Cures Act Cancer Moonshot 2020
- 4. 4Copyright © Veeva Systems 2019 Growing Focus on Rare Diseases Complex Trial Designs Stratified Patient Populations New Realities, New Pressures Increased Cost and Complexity of Running Trials for All Stakeholders
- 5. 5Copyright © Veeva Systems 2019 Clinical Trials Take Longer Than 10 Years Ago A Typical Phase III Protocol (means) 2001–2005 2011–2017 % increase Total Cycle Time from Site Identification to FPI 25.6 weeks 29.1 weeks 14% Time from Patient Visit to Data Entry 6.9 days 8.1 days 17% Last Patient Last Visit (LPLV) to Database Lock 33.4 days 36.1 days 8% Source: Tufts CSDD
- 6. 6Copyright © Veeva Systems 2019 The Industry Has Become Less Efficient Across R&D 79% 81% 84% 88% 1980 1990 2000 2010 Percentage of All Drugs Entering Clinical Testing that FAIL to Receive Approval Capitalized Cost of Drug Development $1,044B $2,558B 2003 2018 • 26% Direct Costs • 18% Time-based • 56% Cost of Failure Source: Tufts CSDD Source: EvaluatePharma; William Blair & Wells Fargo Securities
- 7. 7Copyright © Veeva Systems 2019 We’re Relying More on Partners $38.3 $60.4 $71.6 $68.6 $10.4 $24.3 $43.1 $59.7 $5.9 $9.5 $12.7 $13.7 0 20 40 60 80 100 120 140 160 2000 2005 2010 2015 Internal Staff and Infrastructure CRO Services Investigative Site Services Share of R&D Spending Source: Tufts Center for the Study of Drug Development
- 8. 8Copyright © Veeva Systems 2019 Clinical Trial Information Sharing @ @ Sponsor @ CRO 1 @ CRO 3 @ CRO 2 @ @ Site(s) @ @ @
- 9. 9Copyright © Veeva Systems 2019 Sponsors Use Multiple Tools to Exchange Information with CROs Email, portals, file share most common What methods does your organization used to exchange trial data and documents with study partners? Select all that apply. (Q6) Percentage of total sponsor respondents, N=346
- 10. 10Copyright © Veeva Systems 2019 91% 84% 75% 74% 62% 60% 52% 39% 37% 25% 23% 10% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Sites Smothered in Tech What technology is provided by sponsors? Source: CenterWatch 2016; (n=252 sites) 68% 18% 9% 5% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Somewhat well Not very well Very well Not well at all Sponsor provided tech meets your needs? Low Value Top down tech deployment strategies not meeting needs of sites
- 11. 11Copyright © Veeva Systems 2019 Methods Used To Exchange Information with Sites High use of paper shipments and email What methods does your organization used to exchange trial data and documents with study partners? Select all that apply. (Q6) Percentage of total respondents, N=461
- 12. 12Copyright © Veeva Systems 2019 Challenges with Information Exchange Biggest issues exchanging information with study partners What are the biggest challenges, if any, your organization faces in utilizing the methods of information exchange identified in Q6? Select all that apply. (Q7) Percentage of total respondents, N=461
- 13. 13Copyright © Veeva Systems 2019 Inefficient Information Exchange Drives Challenges in Clinical Research Increased Product Development Costs Lengthier Clinical Trial Cycle Times
- 14. 14 Copyright © Veeva Systems 2019 Modernizing clinical trials is an agency wide priority… Efforts to streamline medical product development can be frustrated by legacy business models that discourage collaboration and data sharing, and the adoption of disruptive technologies that make clinical research more effective. • - Statement by Former FDA Commissioner Scott Gottlieb, M.D.
- 15. 15Copyright © Veeva Systems 2019 Opportunities to Create a Modern Clinical Network From digitizing to sharing Platforms vs. point solutions Connected data Standard DefinitionsTechnology Strategies Success Criteria Domains of information exchange Measure extent to which objective is met Common language Clarity Consistency
- 17. 17Copyright © Veeva Systems 2019 Unified Connected High-Level Elements of a Technology Strategy Purpose-Built
- 18. 18Copyright © Veeva Systems 2019 Steady Adoption of eClinical Applications Does your organization utilize applications developed by third-party vendors in managing clinical studies? If yes, please indicate which are currently in use. (Q.3) Percent of total respondents, N=461 EDC, eTMF, RTSM, CTMS most common
- 19. 19Copyright © Veeva Systems 2019 Unified Clinical Environment Improves Study Execution To the degree your organization needs to better integrate/unify the clinical applications identified in question 3 (e.g., CTMS, EDC, eTMF, etc.), what are the most important drivers? Select all that apply. (Q.5) Percent of total respondents, N=461 Top drivers for unified clinical operations
- 20. 20Copyright © Veeva Systems 2019 Challenges with Information Exchange Biggest issues exchanging information with study partners What are the biggest challenges, if any, your organization faces in utilizing the methods of information exchange identified in Q6? Select all that apply. (Q7) Percentage of total respondents, N=461
- 21. Standards
- 22. 22Copyright © Veeva Systems 2019 A Typical Phase 3 Trial Can Generate… Assumes one study spanning 4 years and 200 sites Does not include site source documents and signed informed consent forms 1,000 parcel shipments 96,000 documents 240,000 pages
- 23. 23Copyright © Veeva Systems 2019 TMF Redundancy and Impact on CRO Productivity 10 Hours to inventory, reconcile upon receipt and merge with other parts 40 Hours to develop and document each document and data exchange agreement across the various project plans Averages for illustration of impact Assumes all studies require some level of transformation ~550 active TMFs at any time 120+ New studies and TMF transfers a year 1 Hour per week, per project to prepare reports, metrics and data 60 Hours to prepare TMF, restructure, rename, export and QC 40,600 Hours Per Year
- 24. 24Copyright © Veeva Systems 2019 DIA TMF Reference Model and Impact on TMF Exchange TMF Exchange Mechanism TMF RM Version 1.0 released, establishing what documents are required in TMF TMF Process Guidance Investigator Expansion Nov 2011 Jun 2018 Jun 2010 Dec 2012 Initial TMF Standard Standard expanded to incorporate documentation generated at the investigator site Working groups formed to create guidance for TMF management best practices Transport protocol which facilitates exchange of eTMF between sponsor and CRO
- 25. 25Copyright © Veeva Systems 2019 Importance of Standard Definitions and Vocabulary Operational Data Sponsor CRO Data Source First Patient in (FPI) First patient randomized into the study First patient was dosed CTMS Last Patient in (LPI) Date last patient completed the study Date last patient completed the study CDMS To achieve clarity sponsors, CROs and sites must agree on data fields
- 26. 26Copyright © Veeva Systems 2019 Opportunities that Standards Can Create •Common Rules •Faster Data Collection •Seamless Information Sharing •Quicker Aggregation •Accurate Analysis
- 27. Success Criteria
- 28. 28Copyright © Veeva Systems 2019 Using Success Criteria to Measure Progress to Goal From digitizing clinical trial information to sharing clinical trial information Sending Receiving Finding Integrating Domains of Information Exchange Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
- 29. 29Copyright © Veeva Systems 2019 Potential Domains of Clinical Trial Information Exchange Domain Measure of Clinical Trial Information Exchange SENDING Clinical trial information is sent via secure electronic mechanism with no special effort RECEIVING Clinical trial information is received via secure electronic mechanism with no special effort FINDING Ability to query clinical trial information from outside institutions INTEGRATED Clinical trial information is integrated from sources outside of your company without the need for manual entry
- 30. 30Copyright © Veeva Systems 2019 Opportunity to Track Industry Information Exchange Over Time Sites, Sponsors and CROs, sending, receiving, finding and integrating clinical trial information 2019
- 31. 31Copyright © Veeva Systems 2019 All Report Need To Simplify Information Exchange Top drivers to streamline information exchange with study partners To the extent your organization needs to streamline/simplify information exchange with study partners, what are the primary drivers? Select all that apply. (Q8) Total respondents, N=461
- 32. 32Copyright © Veeva Systems 2019 Summary of Key Points • Industry driven to modernize clinical research to speed study execution • Improving information exchange is becoming a top priority • Opportunity remains to develop and adopt information exchange standards and industry adoption success criteria
- 33. Thank you