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Optimizing start up activities to decrease your study timeline - Part 1

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This presentation details how medical device companies can utilize enrollment planning tactics to ensure the optimal cost and time for their clinical trials.

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Optimizing start up activities to decrease your study timeline - Part 1

  1. 1. Optimizing Start-up Activities to Decrease Your Study Timeline Part 1: Enrollment Planning
  2. 2. Just the facts – Only 10%1 to 38%2 of studies will enroll on time – Site performance distribution3 • 48% of sites under enroll – Study delay cost upwards of $35,000 / trial / day4 • $1M per month 1 - Getz, K. 2009. Is an Investigative Site Shake-Out Imminent? Applied Clinical Trials 2 - Campbell, MK. 2007. Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technology Assessment 11(48) 1-126. 3 - http://csdd.tufts.edu/news/complete_story/pr_ir_jan-feb_2013 4 - http://www.healthtech.com/zctf
  3. 3. Areas of Focus • Part 1 - Enrollment Planning
  4. 4. Part 1: Enrollment Planning
  5. 5. Anatomy of Enrollment Projections Literature Enrollment Rate / Site / Month Total Number of Sites 8 Site Initiation Rate / Month 3 Enrollment Rate / Month 0.76 Total Number of Sites 8 Site Initiation Rate / Month 3 Enrollment Rate / Month 0.91 Total Number of Sites 8 Site Initiation Rate / Month 6 Enrollment Rate / Month 0.76 Total Number of Sites 8 Site Initiation Rate / Month 6 Enrollment Rate / Month 1.00 Total Number of Sites 8 Site Initiation Rate / Month 6 Enrollment Rate / Month 0.60 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Sites 1 4 7 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 Enrollment 1 4 9 15 21 27 33 40 46 52 58 64 70 76 82 88 94 100 106 111 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Sites 1 4 7 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 Enrollment 1 3 8 12 17 22 27 32 37 42 46 51 56 61 66 71 75 80 85 90 95 100 104 109 111 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Sites 1 4 7 8 8 8 8 8 8 8 8 8 8 8 8 8 8 Enrollment 1 5 11 18 25 33 40 47 55 62 69 76 84 91 98 105 111 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Sites 1 7 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 Enrollment 1 6 12 18 24 30 37 43 49 55 61 67 73 79 85 91 97 103 109 111 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Sites 1 7 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 Enrollment 1 5 10 15 20 25 29 34 39 44 49 54 58 63 68 73 78 83 87 92 97 102 107 111 Scenario 5 Scenario 3 Scenario 1 Scenario 2 Scenario 4
  6. 6. Scenario Planning • Utilize literature for baseline enrollment rates • Build multiple scenarios – Site initiation rate fluctuations – Enrollment rate increases and decreases • Tip: Be realistic in your deviation rates (give up to a 20% band)
  7. 7. Projections
  8. 8. Developing Multiple Paths – Study delivery timelines and Financial model impact • Provides transparency for budget and FTE resources – Supporting an expedited Initiation rate in the above example saves at least 2 months (and approximately $70,000 in study costs) – Utilize for Management buy-in and Resource allocation • Timeframe for commercialization and publication FPFV LPFV LPLV Final Data Analysis PMA Submission FDA Approval Product Launch Publication Scenario 1 Jan-13 Jul-13 Jul-14 Aug-14 Nov-14 Jul-15 Oct-15 Apr-16 Scenario 2 Jan-13 Jul-13 Jul-14 Aug-14 Nov-14 Jul-15 Oct-15 Apr-16 Scenario 3 Mar-13 Aug-13 Aug-14 Sep-14 Dec-14 Aug-15 Nov-15 May-16 Scenario 4 Mar-13 Sep-13 Sep-14 Oct-14 Dec-14 Sep-15 Dec-15 Jun-16 Scenario 5 Apr-13 Nov-13 Nov-14 Dec-14 Mar-15 Dec-15 Mar-16 Sep-16 Enrollment Follow-up Submission Commercial
  9. 9. Check back in February 2015 for Part 2: Agreements and Ethics Review
  10. 10. Optimizing Start-up Activities to Decrease Your Study Timeline For more information or to schedule a discussion, contact us at: info@emergentclinical.com

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