The State of Clinical OutsourcingManaging Risk in Outsourced Clinical TrialsInteractive Discussion Based on Data fromAvoca...
2Panel MembersDenise Calaprice-Whitty (Forum Chair)Senior Consultant, The Avoca GroupAndy LeeSenior VP, Deputy Head of CSO...
3Today’s DiscussionPresentation of Data Highlights from Avoca 2013 IndustrySurvey, and Interactive DiscussionAvoca 2013 In...
42013 Avoca Research: Questions Explored•  Risk-sharing models: What kinds of models are most often used? Underwhat circum...
52013 Avoca Research Respondents237 Respondents•  Sponsors: 113 Respondents from 70 companies–  Approximately half in top ...
6Part One: Risk Sharing
7Types of Risk-sharing BetweenSponsors and Providers•  Provider bonuses for achieving milestones or targets•  Provider pen...
8Prevalence of Risk Sharing: Sponsors0%5%10%15%20%25%30%35%40%45%Strategicpartnerships/alliances(N=28)Preferredproviderrel...
9N=33Magnitude of Bonuses and Penalties3%3%27%61%6% >20% ofcontract value11-20% ofcontract value6-10% ofcontract value2-5%...
10Experience with Risk-sharing by Sponsors54%35%14%41%56%41%6%9%45%0% 20% 40% 60% 80% 100%Guarantee of continued work/reve...
11Experience with Risk-sharing by CROs58%46%24%40%48%47%2%7%29%0% 20% 40% 60% 80% 100%Guarantee of continued work/revenue ...
12Sponsor Data: All RespondentsOverall, how satisfied are you with the work that has been done for you by ClinicalService ...
13Comments on Experiences•  “These relationships require absolute clarity in roles andresponsibilities and up-front planni...
14Comments on Experiences•  “In my opinion a CRO doesnt perform better only becausethey have a bonus or a penalty. The bon...
15Comments on Experiences•  “CRO must have complete decision-making authority on theoperational aspects of trial execution...
16Part Two: Risk Assessment
1739%19%26%13%3%N=31Prevalence of Systematic, Formal RiskAssessments in Outsourced Trials38%18%16%14%14%For >75% ofoutsour...
18Sponsor Use of Systematic Risk Assessment Processes:Is there a difference based on size of company?50%32%13%21%19%15%13%...
19N=63CRO Involvement in Systematic Risk Assessment32%47%16%5%Sponsor Data:For outsourced clinical trials, to whatextent i...
20What Risks are Assessed?0%10%20%30%40%50%60%70%80%90%PatientenrollmentrisksVendorperformancerisksDataqualityrisksOtherti...
21N=68Risk Assessment:Qualitative or Quantitative?43%9%41%7% PrimarilyqualitativePrimarilyquantitativeApproximatelyequal m...
22Part Three: Risk Management
23How often does your risk assessmentprocess lead to the introduction orrefinement of proactive measures designedto reduce...
24Reducing Risk: Sponsor Data51%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%...
25Reducing Risk: Provider DataHow often does your risk assessment process lead to the introduction orrefinement of each of...
26N=50Use of Risk-related Information to DetermineOversight of CROs24%22%20%14%20%For >75% ofclinical trialsFor 51% - 75% ...
27Satisfaction with CROs9% 73%56%9%41%9%4%0% 20% 40% 60% 80% 100%For >50%For <50%Very satisfied Generally satisfiedNeither...
28Satisfaction with Risk Assessment andManagement PerformanceScale of 1 to 5; 1=Very dissatisfied, 5=Very satisfied
29Opportunities to Enhance Understanding38%13%9%23%54%36%31%23%45%8%10%9%0% 20% 40% 60% 80% 100%ExecutiveManagementMiddleM...
30Are risk-based approaches leading to greaterefficiency and higher quality?14%32%38%34%23%6%25%28%0% 20% 40% 60% 80% 100%...
31Thank you!www.theavocagroup.com
32Definitions Included in Avoca SurveyRisk is defined as "the combination of the probability of occurrence of harm and the...
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Managing Risk in Outsourced Clinical Trials

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The State of Clinical Outsourcing : Managing Risk in Outsourced Clinical Trials

Interactive Discussion Based on Data from Avoca’s 2013 Industry Research DIA Forum

June 24, 2013

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Managing Risk in Outsourced Clinical Trials

  1. 1. The State of Clinical OutsourcingManaging Risk in Outsourced Clinical TrialsInteractive Discussion Based on Data fromAvoca’s 2013 Industry ResearchDIA ForumJune 24, 2013
  2. 2. 2Panel MembersDenise Calaprice-Whitty (Forum Chair)Senior Consultant, The Avoca GroupAndy LeeSenior VP, Deputy Head of CSO Platform,Genzyme, a Sanofi CompanyMitchell KatzExecutive Director, Medical Research Operations,Purdue Pharma L.P.Alistair MacdonaldChief Operating Officer, INC Research
  3. 3. 3Today’s DiscussionPresentation of Data Highlights from Avoca 2013 IndustrySurvey, and Interactive DiscussionAvoca 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. 42013 Avoca Research: Questions Explored•  Risk-sharing models: What kinds of models are most often used? Underwhat circumstances? What are the magnitudes of the incentives/penalties? Have they been successful? In what ways? What have beenthe downsides?•  Risk assessments: How often are these conducted, and by whom? Arethey just qualitative, or also quantitative? On what types of risks do theyfocus? Do stakeholders generally agree about risks? Have theseapproaches been successful? In what ways?•  Risk-based management approaches: To what tasks have suchapproaches been applied? Have they been successful? In what ways?What have been the downsides? How has this work been viewed byregulators?
  5. 5. 52013 Avoca Research Respondents237 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. 6Part One: Risk Sharing
  7. 7. 7Types of Risk-sharing BetweenSponsors and Providers•  Provider bonuses for achieving milestones or targets•  Provider penalties for missing milestones or targets•  Guarantees of continued work/revenue stream in exchangefor provider commitments•  Provider stake in outcome of study (e.g., company stock)
  8. 8. 8Prevalence of Risk Sharing: Sponsors0%5%10%15%20%25%30%35%40%45%Strategicpartnerships/alliances(N=28)Preferredproviderrelationships(N=43)Trasactionalrelationships(N=37)Bonuses Penalties Guarantees of continued work/revenue Provider stake in outcomeFor each of the types of outsourcing relationships listed, which of the risk-sharingmodels listed has your company used?
  9. 9. 9N=33Magnitude of Bonuses and Penalties3%3%27%61%6% >20% ofcontract value11-20% ofcontract value6-10% ofcontract value2-5% ofcontract value<2% ofcontract valueSponsor Data:When bonuses are used, what isgenerally the magnitude of themaximum possible bonus?3%3%26%61%7% >20% ofcontract value11-20% ofcontract value6-10% ofcontract value2-5% ofcontract value<2% ofcontract valueSponsor Data:When penalties are used, what isgenerally the magnitude of themaximum possible penalty?N=31
  10. 10. 10Experience with Risk-sharing by Sponsors54%35%14%41%56%41%6%9%45%0% 20% 40% 60% 80% 100%Guarantee of continued work/revenue streamin exchange for provider commitmentsProvider bonuses for achievement ofmilestones/targetsProvider penalties for failure to achievemilestones/targetsPrimarily positive A mix of positive and negative Primarily negativeN545758To date, my experience with each of the below risk-sharing outsourcing modelshas been…
  11. 11. 11Experience with Risk-sharing by CROs58%46%24%40%48%47%2%7%29%0% 20% 40% 60% 80% 100%Guarantee of continued work/revenue streamin exchange for provider commitmentsProvider bonuses for achievement ofmilestones/targetsProvider penalties for failure to achievemilestones/targetsPrimarily positive A mix of positive and negative Primarily negativeN615153To date, my experience with each of the below risk-sharing outsourcing modelshas been…
  12. 12. 12Sponsor Data: All RespondentsOverall, how satisfied are you with the work that has been done for you by ClinicalService 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 value6-10% of contract value2-5% of contract value<2% of contract valueVery satisfied Generally satisfiedNeither satisfied nor dissatisfied Generally dissatisfiedVery dissatisfiedN210212Magnitude of the maximumpossible penalty
  13. 13. 13Comments on Experiences•  “These relationships require absolute clarity in roles andresponsibilities and up-front planning assumptions that wehave not always had, which has caused difficulties alongthe way.”•  “The inclusion of provider bonuses and penalties has had adetrimental affect on study team morale. OK when thetarget has been reached outright, butlots of extra negotiating when anegative outcome.”
  14. 14. 14Comments on Experiences•  “In my opinion a CRO doesnt perform better only becausethey have a bonus or a penalty. The bonus is a way to showthem appreciation at the end but never a motivationalfactor. Aligning with the CRO at the beginning ondeliverables and sharing risks and pitfalls before signing thecontract will increase the trust level and consequently thecommitment.”
  15. 15. 15Comments on Experiences•  “CRO must have complete decision-making authority on theoperational aspects of trial execution (minimal handoffs/decisions by sponsor). CRO must be compensated for athorough feasibility assessment and allowed to select thesuppliers they believe will deliver (without sponsor imposingnon-producing investigators in the mix). Also, sponsorcompany must be willing to provide both the penalty as wellas the reward. In my experience, penalties were neverapplied because there were always mitigating factors(sponsor impacted operational success due to slowresponse or non-response to needs or due to sponsormandate of key requirements- such as SOPs, KOLs, etc.).”
  16. 16. 16Part Two: Risk Assessment
  17. 17. 1739%19%26%13%3%N=31Prevalence of Systematic, Formal RiskAssessments in Outsourced Trials38%18%16%14%14%For >75% ofoutsourcedclinical trialsFor 51% - 75% ofoutsourcedclinical trialsFor 25% - 50% ofoutsourcedclinical trialsFor 1% - 24% ofoutsourcedclinical trialsNeverN=50Sponsors CROsMost sponsors and clinical service providers reported that asystematic risk assessment process was used for the majority oftheir clinical trials.
  18. 18. 18Sponsor 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%YesNoFor >75% of clinical trials For 51% - 75% of clinical trials For 25% - 50% of clinical trialsFor 1% - 24% of clinical trials NeverN1634Top 20?
  19. 19. 19N=63CRO Involvement in Systematic Risk Assessment32%47%16%5%Sponsor Data:For outsourced clinical trials, to whatextent is the CRO generally involved inthe systematic risk assessment?Provider Data:To what extent is your companygenerally involved in the systematic riskassessment?48%39%5%8%N=66
  20. 20. 20What Risks are Assessed?0%10%20%30%40%50%60%70%80%90%PatientenrollmentrisksVendorperformancerisksDataqualityrisksOthertimelinerisksSitecompliancerisksCostrisksClinicaltrialsubjectsafetyrisksDrug/devicesupply-relatedrisksRiskstorightsofclinicaltrialsubjects/ethicsOtherSponsor (N=70) Provider (N=75)When a systematic risk assessment is performed for projects conducted by yourcompany, which of the following risks are typically formally assessed?
  21. 21. 21N=68Risk Assessment:Qualitative or Quantitative?43%9%41%7% PrimarilyqualitativePrimarilyquantitativeApproximatelyequal mixacross trialsIt dependsIs the risk assessment process primarily qualitative (e.g. risks identified anddiscussed), or quantitative (e.g. probabilities and consequences of specific risksestimated quantitatively)?32%15%53%PrimarilyqualitativePrimarilyquantitativeApproximatelyequal mixacross trialsN=66Sponsors CROs
  22. 22. 22Part Three: Risk Management
  23. 23. 23How often does your risk assessmentprocess lead to the introduction orrefinement of proactive measures designedto reduce risk?
  24. 24. 24Reducing Risk: Sponsor Data51%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 dataCapture of performance data (i.e. not clinical trial data)Changes in numbers of sites selectedTraining additions/enhancementsPersonnel additions/enhancementsProtocol amendmentsProcedural additions/enhancementsChanges in locations of sites selectedDecisions regarding CROs/other vendors usedAddition or removal of specific sitesFor >50% of clinical trials For 25% - 50% of clinical trials For 1%-24% of clinical trials NeverN43484950424445474946How often does your risk assessment process lead to the introduction orrefinement of each of the following proactive measures designed to reduce risk?
  25. 25. 25Reducing Risk: Provider DataHow often does your risk assessment process lead to the introduction orrefinement 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 dataCapture of performance data (i.e. not clinical trial data)Procedural additions/enhancementsChanges in numbers of sites selectedTraining additions/enhancementsChanges in locations of sites selectedAddition or removal of specific sitesPersonnel additions/enhancementsProtocol amendmentsDecisions regarding CROs/other vendors usedFor >50% of clinical trials For 25% - 50% of clinical trials For 1%-24% of clinical trials NeverN46474444464344404338
  26. 26. 26N=50Use of Risk-related Information to DetermineOversight of CROs24%22%20%14%20%For >75% ofclinical trialsFor 51% - 75% ofclinical trialsFor 25% - 50% ofclinical trialsFor 1% - 24% ofclinical trialsNeverSponsor Data
  27. 27. 27Satisfaction with CROs9% 73%56%9%41%9%4%0% 20% 40% 60% 80% 100%For >50%For <50%Very satisfied Generally satisfiedNeither satisfied nor dissatisfied Generally dissatisfiedVery dissatisfiedHow often do yourteams use risk-relatedinformation todetermine the leveland/or type of sponsoroversight that you willemploy for your CROpartners?N2327by Use of Risk-related Informationto Determine Oversight
  28. 28. 28Satisfaction with Risk Assessment andManagement PerformanceScale of 1 to 5; 1=Very dissatisfied, 5=Very satisfied
  29. 29. 29Opportunities to Enhance Understanding38%13%9%23%54%36%31%23%45%8%10%9%0% 20% 40% 60% 80% 100%ExecutiveManagementMiddleManagementProjectManagementVery strong understanding Good understandingFair understanding Poor understandingN133911How would you rate your understanding of best practices in risk assessmentand management in clinical trials? (Sponsor Data)While executives generally reported a strong understanding,operational teams may benefit from more training.
  30. 30. 30Are risk-based approaches leading to greaterefficiency and higher quality?14%32%38%34%23%6%25%28%0% 20% 40% 60% 80% 100%more efficient use of resourcesfor your company and/oryour CRO partner?increased quality?Yes Sometimes No Dont know/too soon to tellN6565In general, have your risk assessment and management approaches resulted in…
  31. 31. 31Thank you!www.theavocagroup.com
  32. 32. 32Definitions Included in Avoca SurveyRisk is defined as "the combination of the probability of occurrence of harm and theseverity of that harm" (ISO/IEC Guide 51).RISK ASSESSMENT AND MANAGEMENT (taken from FDA Guidance for Industry Q9:Quality Risk Management).Risk assessment: A systematic process of organizing information to support a riskdecision to be made within a risk management process. It consists of the identification ofhazards and the analysis and evaluation of risks associated with exposure to thosehazards.Risk management: The systematic application of quality management policies,procedures, and practices to the tasks of assessing, controlling, communicating, andreviewing risk.
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