The State of Clinical Outsourcing

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The State of Clinical Outsourcing
Managing Risk in Outsourced Clinical Trials

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The State of Clinical Outsourcing

  1. 1. The State of Clinical Outsourcing Managing Risk in Outsourced Clinical Trials Interactive Discussion Based on Data from Avoca’s 2013 Industry Research !
  2. 2. 2 Panel Members Denise Calaprice-Whitty (Forum Chair) Senior Consultant, The Avoca Group Andy Lee Senior VP, Deputy Head of CSO Platform, Genzyme, a Sanofi Company Mitchell Katz Executive Director, Medical Research Operations, Purdue Pharma L.P. Alistair Macdonald Chief Operating Officer, INC Research
  3. 3. 3 Today’s Discussion Presentation of Data Highlights from Avoca 2013 Industry Survey, and Interactive Discussion Avoca 2013 Industry Survey Topic: Management of Risk in Outsourced Clinical Trials •  Part One: Risk Sharing Models •  Part Two: Risk Assessment •  Part Three: Risk Management
  4. 4. 4 2013 Avoca Research: Questions Explored •  Risk-sharing models: What kinds of models are most often used? Under what circumstances? What are the magnitudes of the incentives/ penalties? Have they been successful? In what ways? What have been the downsides? •  Risk assessments: How often are these conducted, and by whom? Are they just qualitative, or also quantitative? On what types of risks do they focus? Do stakeholders generally agree about risks? Have these approaches been successful? In what ways? •  Risk-based management approaches: To what tasks have such approaches been applied? Have they been successful? In what ways? What have been the downsides? How has this work been viewed by regulators?
  5. 5. 5 2013 Avoca Research Respondents 237 Respondents •  Sponsors: 113 Respondents from 70 companies –  Approximately half in top 20 in terms of revenue •  66% Pharma •  26% Biotech •  5% Device •  3% Combination/Other •  Clinical Service Providers: 124 Respondents from 66 companies –  60% in top 20 in terms of revenue •  86% CROs •  11% Niche •  3% Laboratories
  6. 6. 6 Part One: Risk Sharing
  7. 7. 7 Types of Risk-sharing Between Sponsors and Providers •  Provider bonuses for achieving milestones or targets •  Provider penalties for missing milestones or targets •  Guarantees of continued work/revenue stream in exchange for provider commitments •  Provider stake in outcome of study (e.g., company stock)
  8. 8. 8 Prevalence of Risk Sharing: Sponsors 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% Strategicpartnerships/ alliances(N=28) Preferredprovider relationships(N=43) Trasactional relationships(N=37) Bonuses Penalties Guarantees of continued work/revenue Provider stake in outcome For each of the types of outsourcing relationships listed, which of the risk-sharing models listed has your company used?
  9. 9. 9 N=33 Magnitude of Bonuses and Penalties 3%3% 27% 61% 6% >20% of contract value 11-20% of contract value 6-10% of contract value 2-5% of contract value <2% of contract value Sponsor Data: When bonuses are used, what is generally the magnitude of the maximum possible bonus? 3%3% 26% 61% 7% >20% of contract value 11-20% of contract value 6-10% of contract value 2-5% of contract value <2% of contract value Sponsor Data: When penalties are used, what is generally the magnitude of the maximum possible penalty? N=31
  10. 10. 10 Experience with Risk-sharing by Sponsors 54% 35% 14% 41% 56% 41% 6% 9% 45% 0% 20% 40% 60% 80% 100% Guarantee of continued work/revenue stream in exchange for provider commitments Provider bonuses for achievement of milestones/targets Provider penalties for failure to achieve milestones/targets Primarily positive A mix of positive and negative Primarily negative N 54 57 58 To date, my experience with each of the below risk-sharing outsourcing models has been…
  11. 11. 11 Experience with Risk-sharing by CROs 58% 46% 24% 40% 48% 47% 2% 7% 29% 0% 20% 40% 60% 80% 100% Guarantee of continued work/revenue stream in exchange for provider commitments Provider bonuses for achievement of milestones/targets Provider penalties for failure to achieve milestones/targets Primarily positive A mix of positive and negative Primarily negative N 61 51 53 To date, my experience with each of the below risk-sharing outsourcing models has been…
  12. 12. 12 Sponsor Data: All Respondents Overall, how satisfied are you with the work that has been done for you by Clinical Service Providers (including but not limited to CROs)? 5% 50% 60% 71% 100% 50% 30% 24% 10% 0% 20% 40% 60% 80% 100% >10% of contract value 6-10% of contract value 2-5% of contract value <2% of contract value Very satisfied Generally satisfied Neither satisfied nor dissatisfied Generally dissatisfied Very dissatisfied N 2 10 21 2 Magnitude of the maximum possible penalty
  13. 13. 13 Comments on Experiences •  “These relationships require absolute clarity in roles and responsibilities and up-front planning assumptions that we have not always had, which has caused difficulties along the way.” •  “The inclusion of provider bonuses and penalties has had a detrimental affect on study team morale. OK when the target has been reached outright, but lots of 'extra' negotiating when a negative outcome.”
  14. 14. 14 Comments on Experiences •  “In my opinion a CRO doesn't perform better only because they have a bonus or a penalty. The bonus is a way to show them appreciation at the end but never a motivational factor. Aligning with the CRO at the beginning on deliverables and sharing risks and pitfalls before signing the contract will increase the trust level and consequently the commitment.”
  15. 15. 15 Comments on Experiences •  “CRO must have complete decision-making authority on the operational aspects of trial execution (minimal handoffs/ decisions by sponsor). CRO must be compensated for a thorough feasibility assessment and allowed to select the suppliers they believe will deliver (without sponsor imposing non-producing investigators in the mix). Also, sponsor company must be willing to provide both the penalty as well as the reward. In my experience, penalties were never applied because there were always mitigating factors (sponsor impacted operational success due to slow response or non-response to needs or due to sponsor mandate of key requirements- such as SOPs, KOLs, etc.).”
  16. 16. 16 Part Two: Risk Assessment
  17. 17. 17 39% 19% 26% 13% 3% N=31 Prevalence of Systematic, Formal Risk Assessments in Outsourced Trials 38% 18% 16% 14% 14% For >75% of outsourced clinical trials For 51% - 75% of outsourced clinical trials For 25% - 50% of outsourced clinical trials For 1% - 24% of outsourced clinical trials Never N=50 Sponsors CROs Most sponsors and clinical service providers reported that a systematic risk assessment process was used for the majority of their clinical trials.
  18. 18. 18 Sponsor Use of Systematic Risk Assessment Processes: Is there a difference based on size of company? 50% 32% 13% 21% 19% 15% 13% 15% 6% 18% 0% 20% 40% 60% 80% 100% Yes No For >75% of clinical trials For 51% - 75% of clinical trials For 25% - 50% of clinical trials For 1% - 24% of clinical trials Never N 16 34 Top 20?
  19. 19. 19 N=63 CRO Involvement in Systematic Risk Assessment 32% 47% 16% 5% Sponsor Data: For outsourced clinical trials, to what extent is the CRO generally involved in the systematic risk assessment? Provider Data: To what extent is your company generally involved in the systematic risk assessment? 48% 39% 5% 8% N=66
  20. 20. 20 What Risks are Assessed? 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Patientenrollmentrisks Vendorperformance risks Dataqualityrisks Othertimelinerisks Sitecompliancerisks Costrisks Clinicaltrialsubject safetyrisks Drug/devicesupply- relatedrisks Riskstorightsof clinicaltrialsubjects/ ethics Other Sponsor (N=70) Provider (N=75) When a systematic risk assessment is performed for projects conducted by your company, which of the following risks are typically formally assessed?
  21. 21. 21 N=68 Risk Assessment: Qualitative or Quantitative? 43% 9% 41% 7% Primarily qualitative Primarily quantitative Approximately equal mix across trials It depends Is the risk assessment process primarily qualitative (e.g. risks identified and discussed), or quantitative (e.g. probabilities and consequences of specific risks estimated quantitatively)? 32% 15% 53% Primarily qualitative Primarily quantitative Approximately equal mix across trials N=66 Sponsors CROs
  22. 22. 22 Part Three: Risk Management
  23. 23. 23 How often does your risk assessment process lead to the introduction or refinement of proactive measures designed to reduce risk?
  24. 24. 24 Reducing Risk: Sponsor Data 51% 50% 34% 34% 31% 29% 29% 28% 28% 24% 12% 15% 31% 28% 19% 20% 31% 21% 12% 22% 26% 25% 27% 34% 40% 39% 36% 32% 47% 41% 12% 10% 8% 4% 10% 11% 4% 19% 12% 13% 0% 20% 40% 60% 80% 100% Review plan for performance data Capture of performance data (i.e. not clinical trial data) Changes in numbers of sites selected Training additions/enhancements Personnel additions/enhancements Protocol amendments Procedural additions/enhancements Changes in locations of sites selected Decisions regarding CROs/other vendors used Addition or removal of specific sites For >50% of clinical trials For 25% - 50% of clinical trials For 1%-24% of clinical trials Never N 43 48 49 50 42 44 45 47 49 46 How often does your risk assessment process lead to the introduction or refinement of each of the following proactive measures designed to reduce risk?
  25. 25. 25 Reducing Risk: Provider Data How often does your risk assessment process lead to the introduction or refinement of each of the following proactive measures designed to reduce risk? 47% 45% 38% 34% 31% 23% 21% 18% 16% 14% 22% 19% 32% 36% 35% 33% 27% 33% 19% 13% 26% 30% 30% 23% 33% 35% 48% 43% 56% 50% 4% 6% 7% 2% 9% 5% 8% 9% 24% 0% 20% 40% 60% 80% 100% Review plan for performance data Capture of performance data (i.e. not clinical trial data) Procedural additions/enhancements Changes in numbers of sites selected Training additions/enhancements Changes in locations of sites selected Addition or removal of specific sites Personnel additions/enhancements Protocol amendments Decisions regarding CROs/other vendors used For >50% of clinical trials For 25% - 50% of clinical trials For 1%-24% of clinical trials Never N 46 47 44 44 46 43 44 40 43 38
  26. 26. 26 N=50 Use of Risk-related Information to Determine Oversight of CROs 24% 22% 20% 14% 20% For >75% of clinical trials For 51% - 75% of clinical trials For 25% - 50% of clinical trials For 1% - 24% of clinical trials Never Sponsor Data
  27. 27. 27 Satisfaction with CROs 9% 73% 56% 9% 41% 9% 4% 0% 20% 40% 60% 80% 100% For >50% For <50% Very satisfied Generally satisfied Neither satisfied nor dissatisfied Generally dissatisfied Very dissatisfied How often do your teams use risk-related information to determine the level and/or type of sponsor oversight that you will employ for your CRO partners? N 23 27 by Use of Risk-related Information to Determine Oversight
  28. 28. 28 Satisfaction with Risk Assessment and Management Performance Scale of 1 to 5; 1=Very dissatisfied, 5=Very satisfied
  29. 29. 29 Opportunities to Enhance Understanding 38% 13% 9% 23% 54% 36% 31% 23% 45% 8% 10% 9% 0% 20% 40% 60% 80% 100% Executive Management Middle Management Project Management Very strong understanding Good understanding Fair understanding Poor understanding N 13 39 11 How would you rate your understanding of best practices in risk assessment and management in clinical trials? (Sponsor Data) While executives generally reported a strong understanding, operational teams may benefit from more training.
  30. 30. 30 Are risk-based approaches leading to greater efficiency and higher quality? 14% 32% 38% 34% 23% 6% 25% 28% 0% 20% 40% 60% 80% 100% more efficient use of resources for your company and/or your CRO partner? increased quality? Yes Sometimes No Don't know/too soon to tell N 65 65 In general, have your risk assessment and management approaches resulted in…
  31. 31. 31 Thank you! www.theavocagroup.com

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