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Some Ideas for CTAC better, faster, cheaper David M. Dilts, PhD MBA CPA CMA Managing Partner, Dilts+Partners, LLC Professor, Healthcare Management, Oregon.

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Presentation on theme: "Some Ideas for CTAC better, faster, cheaper David M. Dilts, PhD MBA CPA CMA Managing Partner, Dilts+Partners, LLC Professor, Healthcare Management, Oregon."— Presentation transcript:

1 Some Ideas for CTAC better, faster, cheaper David M. Dilts, PhD MBA CPA CMA Managing Partner, Dilts+Partners, LLC Professor, Healthcare Management, Oregon Health & Science University Portland, Oregon, USA 1

2 When… you hear “Australian clinical trials” what is the first thing that comes to mind? 2

3 Australia is making a great deal of progress The Clinical Trials Action Group (CTAG) 2013 McKeon Report The Federal Budget Measures – Implement the CTAG recommendations – Streamline ethics review The CTAC The Clinical Trials Jurisdictional Working Group (CTJWG) 3

4 These Groups have come up with some great ideas Streamlining Ethics Review “Drop-dead” dates (i.e., have it done in days) Interoperability of systems Australian-wide standards, including standardized cost models Identifying strengths for running clinical trials in Australia 4

5 Special but not unique.. Some of the forces you are facing – Increasing competition – Increased complexity in clinical trial design More exclusion/inclusion criteria, more secondary endpoints, more correlatives – “complex, time consuming, & costly approvals process for ethics and governance” – Insufficient and/or slow accruals to trails – Diverse, heterogeneous and incompatible Information systems Clinical trial cost models Clinical trial practice So, – What you need to be more efficient & more effective – Both locally and internationally 5

6 Things Right and the Right Things Efficiency – Doing things right Effectiveness – Doing the right things 6

7 Three dimensions of comparison Better, faster, cheaper Cautions: – Trying to do all three is confusing and nearly impossible in most situations, so you need to focus – So, key is to set priorities on which 1 (or at most 2) – Right off the bat, the developed world will not be cheaper Unless CROs start thinking about “Total Cost of Ownership”, which is not likely – Deal breaker: not using data to know, to measure performance and to tell people Finally, will doing this achieve the desired objective? 7

8 An Integrated Approach 8 Mission & Strategy Consequential Impact Operational Issues Resource Allocation Synchronicity

9 9 Mission & Strategy Consequential Impact Operational Issues Resource Allocation Synchronicity Mission & Strategy

10 When someone says “Australian wines?” “Australia is one of the world powers of wine. The wine industry of Australia is perhaps the most technologically advanced, forward-thinking on earth, and the success of Australian wines around the world is the envy of wine producers in many on the countries.” Wine for Dummies, 5 th edition 10 Mission

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12 So… 1.In what ways is Australia uniquely qualified to answer the worlds call with respect to clinical research? 2.On what dimension(s) do you want Australia to be recognized and envied by other countries with respect to clinical research?

13 One possible dimension: Variance Reduction Blue – SRC time Red - PI holding time Green – Ethics time What PI believes What Ethics believes What no one talks about High Variance = High Uncertainty = High Dissatisfaction Maister The Psychology of Waiting Lines Mission

14 So… When I asked folks in NSW and Victoria earlier this year what made their trials unique – Most common comment: the diversity of the population But…. – However, one really interesting comment: Australia is a leading indicator (compared to the rest of the world) for one condition Another researcher said…. 14 Mission

15 Another interesting dimension for Australia 15 Australia is # 3 for men and # 7 for women in latest stats Mission What happened?

16 There are a host of different possible dimensions Ones for Quality ProductServiceProfessional Quality Aesthetics Conformance Durability Features Perceived Quality Performance Reliability Robustness Serviceability Access Assurance Communication Competence Convenience Courtesy Credibility Empathy Personalization Responsiveness Security Tangibles Auxiliary Information Location Personalization Professional interaction Professionalism Reputation Staff interactions/ competence Overarching: 1. Economics 2. Reliability

17 Key to success Once the critical dimension(s) have been selected: – Communicate, communicate, communicate – Verify and assure goal alignment – Manage the process using project management skills Knowledge / Reputation Quality / Speed Access / Adaptability Value / Incentives Qualifier Capabilities / Technologies 17 Mission

18 18 Mission & Strategy Consequential Impact Operational Issues Resource Allocation Synchronicity Operational Issues

19 Time for Opening a Phase III Cooperative Group Trial Median: 116 to 252 days* Range: days Median: 784 to 808 days* Range: days * Depending upon site, based on the Phase III trials studied Total Median Time from idea to opening~920 days (2.5 years) Range: 456 – 2440 days ( yrs) 19 Dilts DM et al, “Chutes and Ladders”, Clin Can Res, (22): Operational

20 Critical Findings No matter how much the PIs complained, Ethics review was never the rate limiting process – Budget and contract reviews were much longer – Note: be careful of floating-bottlenecks No one knew the scope of the problem using data – But everyone had an opinion – i.e., Eminence- not evidence-based decision making The variance was totally unexpected Everyone wanted to share data & systems – So long as it was their system that was selected – Interoperability is a hard problem 20 Operational

21 Results using evidence (1) Accruals Per Trial 1 Six Major NCI Comprehensive Center Centers 1 Excludes pediatric studies; Therapeutic Studies Only 2 Accruals per trial at time of closure 3 Over 500 of nearly 1800 trials result in zero accruals Accrual Per Trial 2 CCC 1CCC 2CCC 3CCC 4CCC 5CCC 6Total Time Period1/2001-7/20051/2000-9/20061/ /20051/2000-4/20071/ /20081/2000-3/2009 N , %26.9% 34.4%22.1%35.1%29.0% 3 1 to 432.4%31.0%26.9%31.3%29.8%38.1%32.6% 5 or more46.6%42.1%46.2%34.4%48.1%26.8%38.4% 21 Operational

22 Results Using Evidence (2) All phase III studies activated and closed to accrual between 1/2000 – 7/2006 Color Code: red : studies taking greater than the median time to open blue: studies taking less than the median time to open gray: studies closed due to reasons other than poor accrual 22 Dilts DM et al, “Chutes and Ladders”, Clin Can Res, (22): Operational

23 23 Mission & Strategy Consequential Impact Operational Issues Resource Allocation Synchronicity Resource Allocation

24 Using a standard, “plain” trial, the differences in start-up costs 24 ~$22,500 difference in start-up costs 24

25 Using a standard, “plain” trial, the differences in per-pt cost 25 Resource Allocation 25 ~$11,000 difference per pt

26 26 Percent of Clinic FTE Line denotes average FTE Make “League Standings” Public Different “Branches” Resource Allocation

27 Another “League Standing” Method Analysis of inputs versus outputs Note: these are only example inputs/outputs Key: what are your critical inputs & outcomes? 27 DEA Paper forthcoming Resource Allocation

28 28 Mission & Strategy Consequential Impact Operational Issues Resource Allocation Synchronicity Consequential Impact The most difficult of all the tasks to do

29 Evaluation of a Portfolio on Strategic Dimensions (n=161) 29 Consequential Impact Red = actual Blue = anticipated (desired)

30 Mission & Strategy Consequential Impact Operational Issues Resource Allocation Synchronicity 30

31 What happens if we double a cooperative group’s budget? 31 Answer: nearly nothing …But they wouldn’t turn the money down Synchronicity

32 High Level Process Flow for Phase III Studies 32 Synchronicity

33 * Simulation period defined over a period of 5 years (1825 Calendar Days) * Note: Axes on the Timing Distribution Graphs are different Simulation Results of Working Together 33 / st. err Synchronicity

34 Synchronizing Data Capture ScreeningDiagnostics Treatment Planning Treatment Follow-up Process for flow is fairly consistent across sites BUT Data elements are captured and utilized inconsistently across sites at multiple points in the workflow duplication  missing  responsibility  source/location 34 Dilts, DM; Cheng, SK; et al. “ Developing the Next-Generation Cancer Care System Around the Patient and the Provider: Analysis of Workflow and Addressing Pain Points” (Under Review) Synchronicity

35 Synchronicity is where powerful metrics can be developed Total Time reduction: – To open a trial – To complete a trial – When the next trial opening will be available – Time to: publication, regulatory approval, etc. Total Quality Improvement – Measurable quality improvements among all sites – Demonstrated better quality than other countries Variance Reduction – Intra- and inter-institutional 35 Synchronicity

36 An Integrated Approach 36 Mission & Strategy Consequential Impact Operational Issues Resource Allocation Synchronicity

37 What happens using this framework? The Portfolio became more aligned with the Vision & Mission, resulting in: 52% reduction in number of studies opened and a 4% increase in new patients enrolled on therapeutic trials Patients on a more aligned and prioritized set of trials 20% increase in studies with complete enrollment* 7% decrease in studies with non-enrollment** With metrics for transparency & embed accountability, and 54% reduction in median development time * Complete enrollment = Within 75% of accrual ceiling ** Non-enrollment = below 25% of accrual ceiling

38 To make it work… Know what you will focus on: – Efficiency and Effectiveness Faster or Better and achieving the desired objectives? Managing the process well – Use professional project managers (and conflict coaches) Always use data (preferably “their” data) And…. 38

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40 Finally… In the future, when someone says “Australian Clinical Trials” what is the first thing you want them to think of? 40

41 41 Thank you

42 Why Transformation Efforts Fail Kotter, Not establishing a great enough sense of urgency 2.Not creating a powerful enough guiding coalition 3.Lacking a vision ( or a clear vision) 4.Undercommunicating the vision by a factor of 10 5.Not removing obstacles to the new vision 6.Not systematically planning for, and creating, short-term wins 7.Declaring victory too soon 8.Not anchoring changes in the corporation’s culture

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44 General Thought Where should you spend the money: – On specific kinds of trials, or – On infrastructure to support lots of trials? Key question: what best achieves your mission? 44 Resource Allocation


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