The State of Clinical Outsourcing: Do Outsourcing Partnerships Promote or Impede Progress toward Clinical Trial Optimization?
- 1. The State of Clinical Outsourcing: Do Outsourcing Partnerships Promote or Impede Progress toward Clinical Trial Optimization? Data from the 2014 Avoca Industry Survey Denise Calaprice-Whitty, Ph.D. Senior Consultant The Avoca Group @TheAvocaGroup
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All other trademarks are the property of their respective owners. 2 3. 3 Panel Members Denise Calaprice-Whitty, Ph.D. (Moderator) Senior Consultant, The Avoca Group Rhonda Henry Vice President of Alliance Management and Strategic Sales, PPDI Elspeth Carnan, Ph.D. Executive Director, Center of Operational Efficiency, Innovation, and Process Improvement, Global Development Ops, Amgen Kathleen Ford Senior Vice President, Head of Global Clinical Operations, Merck 4. 4 2014 Avoca Industry Survey The Big Question: How are intelligent, data-driven approaches* being used in clinical development today? What factors promote their use, and what factors inhibit it (with a focus on outsourcing)? 5. 5 Survey Definition * Intelligent, data-driven approach: One that makes use of operational (e.g. performance) and/or clinical data along with appropriate analytical techniques, in order to optimize aspects of clinical development (protocol design, Investigator selection, patient recruitment approaches, resource allocation, e.g. risk-based monitoring), etc. 6. 6 Background: 2014 Avoca Industry Survey Why now? Big Data concepts have become part of our daily experience, with successful and highly visible use in other industries In our industry, unprecedented availability and aggregation of digital information Even further promoted by high rates of outsourcing Continued time, cost, and quality pressures on clinical development Clear areas of opportunity 7. 7 Areas of opportunity, examples: Overall protocol design Procedural or eligibility aspects of protocols Selection of sites, regions, providers, or patient recruitment approaches Project management/oversight As with any change, however, companies must recognize and effectively manage the forces that impact uptake and success. Background: 2014 Avoca Industry Survey 8. 8 Specific research questions addressed: Frequency of use of intelligent approaches in different key areas Rate of advancement over the last 2 years Forces contributing (positively or negatively) to advancement General Impact of outsourcing partnerships and outsourcing models Early engagement of partners in protocol and development planning Experience with technology, training, and other implementation and change management solutions Background: 2014 Avoca Industry Survey 9. 9 2014 Avoca Industry Survey: Respondents Sponsors: 127 Respondents Approximately 45% in top 20 in terms of revenue 67% Pharma 28% Biotech 3% Device 2% Combination/Other Clinical Service Providers: 105 Respondents 64% in top 20 in terms of revenue 67% CROs 33% Other/Niche 10. 10 Results: Application of Approaches How frequently are intelligent approaches applied? How much advancement has been made in the last 2 years? 11. 11 % of Respondents Reporting that Most of their Clinical Trials Use Intelligent Approaches (activities performed by the respondents company) 0% 20% 40% 60% Provider selection Cost benchmarking/ management Region selection Specific protocol procedures or eligibility criteria Site selection Project management/ oversight Overall protocol designs Data collection tools Patient/volunteer recruitment Monitoring (e.g. risk-based) Sponsors (N=87) 0% 20% 40% 60% Site selection Region selection Project management/ oversight Cost benchmarking/ management Data collection tools Provider selection Specific protocol procedures or eligibility criteria Patient/volunteer recruitment Monitoring (e.g. risk-based) Overall protocol designs Providers (N=62) 12. 12 % of Respondents Reporting at least Moderate Advances in the Use of Intelligent Approaches over the Last 2 years (activities performed by the respondents company) 0% 20% 40% 60% 80% Provider selection Site selection Project management/ oversight Overall protocol designs Specific protocol procedures or eligibility criteria Cost benchmarking/ management Region selection Data collection tools Monitoring Patient/volunteer recruitment Sponsors (N=84) 0% 20% 40% 60% 80% Region selection Site selection Data collection tools Monitoring Provider selection Specific protocol procedures or eligibility criteria Project management/ oversight Cost benchmarking/ management Overall protocol designs Patient/volunteer recruitment Providers (N=65) 13. 13 % of Respondents Reporting Great Advances in the Use of Intelligent Approaches over the Last 2 years (activities performed by the respondents company) 0% 10% 20% 30% 40% Provider selection Overall protocol designs Data collection tools Monitoring Project management/ oversight Cost benchmarking/ management Patient/volunteer recruitment Specific protocol procedures or eligibility criteria Site selection Region selection Sponsors (N=84) 0% 10% 20% 30% 40% Site selection Monitoring Data collection tools Patient/volunteer recruitment Region selection Overall protocol designs Provider selection Project management/ oversight Specific protocol procedures or eligibility criteria Cost benchmarking/ management Providers (N=65) 14. 14 Results: Impact of Outsourcing on Application To what extent does the use of intelligent approaches depend (positively or negatively) on outsourcing? Why and in what ways? 15. 15 Sponsors: To what extent do your company's clinical service providers either contribute to, or detract from, your company's use of "intelligent clinical development approaches? 19% 14% 21% 22% 7% 15% 4% 7% 3% 7% 50% 43% 37% 35% 37% 29% 36% 31% 26% 21% 26% 27% 35% 32% 36% 36% 41% 50% 40% 52% 46% 39% 3% 6% 7% 6% 13% 15% 11% 20% 20% 26% 26% 4% 6% 9% 0% 20% 40% 60% 80% 100% Site selection Region selection Monitoring (e.g. risk-based monitoring) Patient/volunteer recruitment Project management/oversight Data collection tools Other operational processes Provider selection Specific protocol procedures or eligibility criteria Overall protocol designs (e.g. adaptive) Cost benchmarking/management Essential contribution Significant contribution Little contribution No contribution Negative contribution N 70 69 73 72 67 68 56 55 66 57 57 16. 16 Provider Contributions Availability of data Availability of models and experience Understanding of regulatory perspective Technology Resource availability 17. 17 Levels of Satisfaction with the Application of Intelligent" Approaches (rating scale 1=very dissatisfied to 5=very satisfied) Sponsor ratings Difference Service provider self ratings In-house teams Service providers N= 65 54 54 Cost benchmarking/management 3.3 2.5 0.8 3.2 Provider selection 3.4 2.9 0.5 3.4 Overall protocol designs (e.g. adaptive) 3.4 2.9 0.5 3.8 Specific protocol procedures or eligibility criteria 3.4 3.0 0.4 3.7 Project management/oversight 3.4 3.0 0.4 3.4 Site selection 3.3 3.1 0.2 3.9 Region selection 3.4 3.3 0.1 3.7 Patient/volunteer recruitment 3.2 3.1 0.1 3.6 Data collection tools (e.g. designs associated with lowest query rates) 3.4 3.3 0.1 3.7 Other operational processes 3.2 3.1 0.1 3.4 Monitoring (e.g. risk-based monitoring) 3.1 3.1 0 3.5 18. 18 Sponsors: For outsourced clinical trials, how often do you engage CROs early in the clinical trial execution process in order to leverage their experience? 19% 43% 31% 5% 2% Always Most of the time Sometimes Seldom Never N=86 19. 19 Sponsors: Collaboration with CROs on Protocol Design 7% 16% 29%24% 24% Always Most of the time Sometimes Seldom Never 17% 54% 23% 5% 1% Greatly Somewhat Little None Reduces protocol quality For outsourced clinical trials, how often do you collaborate with your CROs on protocol design? To what extent do you feel that collaboration with CROs on protocol design improves quality? N=83 N=76 20. 20 Results: Impact of Outsourcing on Application Does the outsourcing model make a difference? 21. 21 Impacts of Full-Service vs. Functional Strong opinions in both directions! Full-service outsourcing: Promotes approaches that require data to be shared, or tasks to be coordinated, across functional areas (e.g. fully integrated intelligent technologies) Promotes greater sense of ownership among CROs, hence promoting use of more optimized approaches But can impede optimization since much is limited by weakest provider areas Functional outsourcing: Promotes excellence and efficiency in single tasks 22. 22 Impacts of Strategic Alliances Positive impacts: Aggregation of data for partnership studies Access to data as part of Agreement Greater investment in aligned systems, metrics, processes Cost benefits allow more resources to be directed toward innovation Dedicated resources: positive impact on resource availability Increases trust, hence willingness to innovate More cooperation in early stages of programs opportunity to discuss and plan Partners under increased pressure to show value, so come up with more creative approaches 23. 23 Impacts of Strategic Alliances Negative impacts: Lack of competition removes incentive to innovate get comfortable Fewer benefits of cross-vendor expertise constrains alliance par