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Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
Clinical Recruitment Planning Strategies
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Clinical Recruitment Planning Strategies

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As promised here is another patient recruitment planning presentation

As promised here is another patient recruitment planning presentation

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  • 1. Clinical Recruitment Planning Strategies: When is the Right Time to Plan, Implement, and Spend? Manley R. Finch, PhD(c), MPH Vice President, Clinical Research SleepMed, Inc.
  • 2. Disclosures <ul><li>SleepMed, Inc. </li></ul><ul><ul><li>Vice President of Clinical Research </li></ul></ul><ul><ul><li>Medical Device & Diagnostic Services </li></ul></ul><ul><li>HIV Nutrition Network (HNN), NPO </li></ul><ul><ul><li>Executive Director </li></ul></ul><ul><li>Coastal Clinical Consultants, Inc. </li></ul><ul><ul><li>President & CEO </li></ul></ul>
  • 3. References <ul><li>Bain & Company. Has the Pharmaceutical Model Gone Bust? (www .bain.com ; December 8 th , 2003.) </li></ul><ul><li>Colier, R. Rapidly rising clinical trial costs worry researchers. CMAJ. January 3, 2009. 180(3). </li></ul><ul><li>DiMasi, JA, Hansen, RW, Grabowski, HG. The price of innovation: New estimates of drug development costs. J Health Eco 22(2003)151-185. </li></ul><ul><li>Johnston, SC, Hauser, SL. Clinical Trials: Rising Costs Limit Innovation. Ann Neurol. Dec;62(6):A6-7. </li></ul><ul><li>Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile, 2009. (Washington, DC: PhRMAA, April 2009. </li></ul><ul><li>The Center for Information and Study on Clinical Research Participation (CISCRP). Jan, 2009. ( www.ciscrp.org ). </li></ul><ul><li>Thompson CenterWatch. ( www.centerwatch.com ) </li></ul><ul><li>Code of Federal Regulations (www.fda/cder/CFR) </li></ul>
  • 4. Recruitment Planning Topics <ul><li>Clinical Development Program Background. </li></ul><ul><li>Cost of Research Increasing – ROI Decreasing. </li></ul><ul><li>Impact of Program Delays to Company. </li></ul><ul><ul><li>Marketing Considerations – Lost or Gained Opportunities </li></ul></ul><ul><ul><li>Operations Costs – An Often Overlooked Fiscal Consideration </li></ul></ul><ul><li>Criteria for Planning Recruitment Programs. </li></ul><ul><ul><li>Corporate Strategy </li></ul></ul><ul><ul><li>Program – Disease State Challenges </li></ul></ul><ul><ul><li>Protocol Challenges </li></ul></ul>
  • 5. Why Rapid Enrollment is Not Only Important – It is Critical
  • 6. File IND at FDA File NDA at FDA Discovery/ Preclinical Testing Phase I Phase II Phase III FDA Source: PhRMA http://www.phrma.org/publications/publications//2002-10-21.601.pdf Clinical Trials Phase IV Drug Development Process Years 6.5 Test Population Laboratory and animal studies Purpose Assess safety, biological activity and formulations Success Rate 5,000 compounds evaluated 1.5 2 3.5 20 to 100 healthy volunteers 100 to 500 patient volunteers 1,000 to 5,000 patient volunteers Determine safety and dosage Evaluate effectiveness look for side effects Confirm effectiveness, monitor adverse reactions from long-term use 13 enter trials 1.5 Post market testing required by FDA Review process & approval 1 approved
  • 7. Costs of Research <ul><li>Blockbuster model is in jeopardy and unlikely to continue. </li></ul><ul><ul><li>R&D costs are continuing to rise without a concomitant revenue return. </li></ul></ul><ul><ul><li>Aggressive generic posture decreasing exclusivity time. </li></ul></ul><ul><ul><li>CMS, HMOs, Insurance, 3 rd Party payors reluctant to “foot bill” for costs of new drugs. </li></ul></ul><ul><ul><li>Administration pushing for ever tighter heath-care cost restraints. </li></ul></ul><ul><ul><li>EU cost restraints limit overseas sales revenue. </li></ul></ul><ul><ul><li>Other countries pushing for decease in exclusivity periods. </li></ul></ul>
  • 8. Costs of Research <ul><li>Previous estimates place the cost of R&D at ~ 800 Million per drug. </li></ul><ul><li>Cost of new development now 1.3 billion. </li></ul><ul><li>Recent estimates high as 1.7 billion by 2014. </li></ul><ul><ul><li>Discovery, preclinical, clinical, filing. </li></ul></ul><ul><ul><li>55% increase over 2000 numbers </li></ul></ul><ul><ul><li>Factors in failed drug development cost. </li></ul></ul><ul><li>“ Go-to-Market” </li></ul><ul><ul><li>Previous estimates at 1 in 8. </li></ul></ul><ul><ul><li>Newer estimates at 1 in 13. </li></ul></ul><ul><ul><li>Block Busters are becoming “Me Too”. </li></ul></ul><ul><li>Estimated that 1 in 5 - 6 will pay returns. </li></ul>
  • 9. Costs of Research <ul><li>Total industry spend is estimated to be 65.2 billion USD in 2009 </li></ul><ul><ul><li>R&D percent of sales is > 20% domestic. </li></ul></ul><ul><ul><li>R&D percent of sales is 17.4% global. </li></ul></ul><ul><ul><li>Demonstrates that global sales are a small fraction of US sales. </li></ul></ul><ul><ul><li>US bears the brunt of new drug development. </li></ul></ul><ul><ul><li>US Pharma therefore must contain costs. </li></ul></ul>
  • 10. Development Key Points <ul><li>Clinical development costs increase 7.4% higher than inflation – clinical trial costs responsible. </li></ul><ul><li>100 - 350 million USD to complete clinical phases. </li></ul><ul><ul><li>5 - 7 years timeline for clinical </li></ul></ul><ul><ul><ul><li>Time and costs increasing. </li></ul></ul></ul><ul><ul><li>Equates to: </li></ul></ul><ul><ul><ul><li>14-20 to 50-70 million USD per year </li></ul></ul></ul><ul><ul><ul><li>100K to 200K per day clin ops cost alone! </li></ul></ul></ul>
  • 11. Development Key Points <ul><li>$$- TIME IS MONEY -$$ </li></ul><ul><li>Every day the trial is operating is 100 to 200k USD operational cost alone . </li></ul>
  • 12. Development Key Points <ul><li>Marketing Considerations and Opportunities </li></ul><ul><ul><li>Blockbuster drug can generate 2-5 million USD per day in sales revenue ( 750 to 1,500 mil/year) </li></ul></ul><ul><ul><li>Market share decreases dramatically based on tier approval; First in Class, First to Market, 2 nd to Market etc. </li></ul></ul><ul><ul><li>Windows for marketing a drug are dynamic </li></ul></ul><ul><ul><li>First to market wins market share </li></ul></ul><ul><ul><li>Viagra ® versus Cialis ® as an example </li></ul></ul>
  • 13. Development Key Points <ul><li>$$- TIME IS MONEY -$$ </li></ul><ul><li>Delays in Time to Market </li></ul><ul><ul><li>2 to 5 million per day marketing. </li></ul></ul><ul><ul><li>700 to 1,500 million per year revenue </li></ul></ul><ul><ul><li>Low approval tier decereases market share from 75/80% to 25% or less. </li></ul></ul>
  • 14. Development Key Points <ul><li>Corporate Fiscal Management </li></ul><ul><ul><li>Budgets are developed for 3-5-7 year plans. </li></ul></ul><ul><ul><li>Forecasts are performed yearly and quarterly. </li></ul></ul><ul><ul><li>Development program budgets span across almost a decade. </li></ul></ul><ul><ul><li>Shifting funding from one year or quarter may mean raiding funds for other clinical programs, acquisitions, mergers, bonuses, pay increases, etc. </li></ul></ul><ul><ul><li>Executive management take very seriously delays that impact corporate investor relations and solvency. </li></ul></ul>
  • 15. Development Key Points <ul><li>Impact of Clinical Development Program Delays </li></ul><ul><ul><li>Delays impact traditional development models, employees, stakeholders, investors, and the public. </li></ul></ul><ul><ul><li>Paradigm shifts: Many companies are outsourcing clinical programs to CROs and Clinical Service Providers. </li></ul></ul><ul><ul><li>Mergers/Acquisitions: Many companies are undergoing mergers to consolidate costs and create synergies. </li></ul></ul><ul><ul><li>Layoffs: Companies are more often cutting back on employee debt load to conserve finances for development and solvency. </li></ul></ul>
  • 16. Development Key Points <ul><li>$$- TIME IS MONEY -$$ </li></ul><ul><li>Operational Costs </li></ul><ul><li>Marketing and Market Opportunity Costs </li></ul><ul><li>Corporation Cash Flow and Solvency </li></ul><ul><li>Mergers, Layoffs, and Paradigm Shifts </li></ul>
  • 17. Development Key Points <ul><li>Clinical Development Program Timelines </li></ul><ul><ul><li>Clinical endpoints set by FDA, EMEA, and other CAs. </li></ul></ul><ul><ul><li>Treatment duration defined by endpoints selected. </li></ul></ul><ul><ul><li>These factors are not dynamic and dictate length of program, project, and protocol duration. </li></ul></ul><ul><ul><li>Dynamic influencers are study start up, length of recruitment, data cleaning, data analysis, NDA package assembly, and NDA submission. </li></ul></ul><ul><ul><li>Study start-up and recruitment are low hanging fruit for timeline compression – </li></ul></ul><ul><ul><li>Also areas for dramatic delays </li></ul></ul>
  • 18. Timelines <ul><li>Timeline Compression or Delay </li></ul><ul><ul><li>Patient enrollment period is critical to timelines. </li></ul></ul><ul><ul><ul><li>Critical Milestones </li></ul></ul></ul><ul><ul><ul><ul><li>First site activated (FSA) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Last site activated (LSA) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>First patient in (FPI). </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Last patient in (LPI). </li></ul></ul></ul></ul><ul><ul><ul><ul><li>First patient out (FPO). </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Last patient out (LPO). </li></ul></ul></ul></ul>
  • 19. Timelines = Costs <ul><li>$$- TIME IS MONEY -$$ </li></ul><ul><li>Shortening study start up by one day </li></ul><ul><ul><li>= 100-200K operational costs. </li></ul></ul><ul><ul><li>= 2-5 million marketing or sales revenue. </li></ul></ul><ul><li>Delays result in similar losses </li></ul><ul><li>-PER DAY- </li></ul>
  • 20. $ THE RACE IS ON $
  • 21. Let Us Never Forget <ul><li>The most important reason </li></ul><ul><li>“ The Patient is Waiting” </li></ul>
  • 22. How to Know When to Plan
  • 23. First Review Your Product Development Program Strategy <ul><ul><li>How important is it to company goals? </li></ul></ul><ul><ul><li>What is the desired revenue stream? </li></ul></ul><ul><ul><li>What is the impact to revenue if approval tier is lower than desired? </li></ul></ul><ul><ul><li>What are your timelines to obtain 1 st , 2 nd , 3 rd to market? </li></ul></ul><ul><ul><li>What is the cost differential between tiers versus the cost of a comprehensive patient recruitment program? </li></ul></ul>
  • 24. Executive Strategic Map <ul><li>Desired revenue stream e.g. corp goals for shared holder value. </li></ul><ul><li>Program timeline drivers for completion to meet needed tier. </li></ul><ul><li>(Cost differential for approval tiers - </li></ul><ul><li>Cost of recruitment plan) = </li></ul><ul><li>Equals ROI Drivers for RP </li></ul>
  • 25. Key Indicators for Planning <ul><li>Recap so far….. </li></ul><ul><ul><li>Importance to Executive Strategy </li></ul></ul><ul><ul><li>Relevance to Corporate Solvency </li></ul></ul><ul><ul><li>Approval Tier –Drives Market Share </li></ul></ul><ul><ul><li>Timelines for Approval </li></ul></ul><ul><ul><li>Cost of Success vs. Cost of Failure </li></ul></ul><ul><ul><li>ROI for Planning </li></ul></ul>
  • 26. Program Challenges <ul><li>Sample Size </li></ul><ul><ul><li>How many patients do you need for your approval program? </li></ul></ul><ul><ul><li>How many patients per trial and by when do you need them? </li></ul></ul><ul><ul><li>How many patients are there in the entire enrollable population? </li></ul></ul><ul><ul><li>How do you know? </li></ul></ul>
  • 27. Program Challenges <ul><li>Define the disease parameters. </li></ul><ul><ul><li>Disease severity </li></ul></ul><ul><ul><li>Disease awareness </li></ul></ul><ul><ul><li>Disease vs. syndrome </li></ul></ul><ul><ul><li>Health Belief Model – susceptibility? </li></ul></ul><ul><li>Disease Population </li></ul><ul><ul><li>Disease prevalence. </li></ul></ul><ul><ul><li>Disease incidence. </li></ul></ul><ul><ul><li>Population mortality rate. </li></ul></ul>
  • 28. Define Enrollment Population <ul><li>Population Size </li></ul><ul><ul><li>How many in total prevalence pool? </li></ul></ul><ul><ul><li>How many are on effective therapy? </li></ul></ul><ul><ul><li>Traditional participation rate? </li></ul></ul><ul><ul><li>(about 20% of patients will consider trial) </li></ul></ul><ul><li>Domestic vs. Global </li></ul><ul><ul><li>Ethnic and geographical diversity? </li></ul></ul><ul><ul><li>Multinational required? </li></ul></ul><ul><ul><li>Country specific or cultural barriers? </li></ul></ul><ul><ul><li>Global population of disease? </li></ul></ul>
  • 29. Define Enrollment Population <ul><li>Competition </li></ul><ul><ul><li>How many on approved drugs? </li></ul></ul><ul><ul><li>How many on concurrent clinical trials? </li></ul></ul><ul><ul><li>Do your own trials or programs overlap? </li></ul></ul><ul><ul><li>How many already on your trials? </li></ul></ul>
  • 30. Key Indicators for Planning <ul><li>Disease Indication </li></ul><ul><li>Sample Size Needed for Approval </li></ul><ul><li>Disease Awareness – Susceptibility </li></ul><ul><li>Prevalence Pool Size </li></ul><ul><li>Competition for Pool </li></ul><ul><li>Global Issues – Cultural barriers </li></ul><ul><li>All Translates to Available </li></ul><ul><li>Enrollment Pool Size </li></ul>
  • 31. Define Logistics/PM <ul><li>Project Management & Logistics </li></ul><ul><ul><li>Program master timelines. </li></ul></ul><ul><ul><li>Critical path vs. float. </li></ul></ul><ul><ul><li>Windows for execution. </li></ul></ul><ul><ul><li>Go – No Go Structure. </li></ul></ul>
  • 32. Protocol Challenges <ul><li>Size of the PI pool? </li></ul><ul><li>Experience level of the PI pool? </li></ul><ul><li>How restrictive are your inclusion and exclusion criteria? </li></ul><ul><li>How complex is your trial? </li></ul><ul><ul><li>General med, in-patient, critical care? </li></ul></ul><ul><ul><li>Special protocol needs/equipment? </li></ul></ul><ul><ul><ul><li>Investigator impact </li></ul></ul></ul><ul><ul><ul><li>Participant impact </li></ul></ul></ul>
  • 33. Community Stakeholders <ul><li>Program Rationale </li></ul><ul><ul><li>First in class </li></ul></ul><ul><ul><li>Innovative </li></ul></ul><ul><ul><li>Orphan </li></ul></ul><ul><ul><li>“ Me Too” </li></ul></ul><ul><li>Program/Protocol Support </li></ul><ul><ul><li>Scientific community </li></ul></ul><ul><ul><li>Key Opinion Leaders – Experts </li></ul></ul><ul><ul><li>Patient support – advocacy groups </li></ul></ul><ul><ul><li>Third party payors; CMS, HMOs, Insurance </li></ul></ul>
  • 34. Key Indicators for Planning <ul><li>Complicated Protocols </li></ul><ul><li>Clinical Endpoints </li></ul><ul><li>Restrictive I/E Criteria </li></ul><ul><li>PI Exposure </li></ul><ul><li>Program Rationale – Market Conditions </li></ul><ul><li>Community Stakeholder Acceptance </li></ul><ul><li>Enrollment Resistance </li></ul>
  • 35. Clinical Trial Recruitment Planning <ul><li>Plan Early, Implement Early, Band-Aiding Costs More! </li></ul><ul><li>Only 7% of trials enroll on time. </li></ul><ul><li>Over 22% delayed < 1 month. </li></ul><ul><li>Over 70% delayed by > 1 month. </li></ul><ul><li>Approx. 40% delayed > 1 but < 6 months. </li></ul><ul><li>Approx. 20% delayed > 6 months. </li></ul>
  • 36. Timelines = Costs <ul><li>$$- TIME IS MONEY -$$ </li></ul><ul><li>Shortening enrollment up by one day </li></ul><ul><ul><li>= 100-200K operational costs. </li></ul></ul><ul><ul><li>= 2-5 million marketing or sales revenue. </li></ul></ul><ul><li>Delays result in similar losses </li></ul>
  • 37. Clinical Trial Recruitment Planning <ul><li>30 Day Delay = </li></ul><ul><li>3 - 6 million Clinical Ops cost. </li></ul><ul><li>60-150 million Marketing cost. </li></ul>
  • 38. Clinical Trial Recruitment Planning <ul><li>Patient Recruitment Program Costs </li></ul><ul><li>1 – 3 million per Phase III </li></ul><ul><li>5 – 7 million per Program </li></ul><ul><li>5 – 12 % of a one month delay </li></ul><ul><li>Based on estimates from experience. </li></ul>
  • 39. When to Plan? As soon as you begin to write the development program
  • 40. Educate Internal Stakeholders <ul><li>Executive Decision Makers </li></ul><ul><li>Investors and Stockholders </li></ul><ul><li>VP Level Budget Holders </li></ul><ul><li>Medical Directors </li></ul><ul><li>Clinical Operations Directors </li></ul><ul><li>New BD and Marketing </li></ul><ul><li>Medical Affairs </li></ul>
  • 41. Must not burn recruitment budget Must be Band-aiding again
  • 42. Thank You Questions?

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