Clinical Recruitment Planning Strategies

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As promised here is another patient recruitment planning presentation

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Clinical Recruitment Planning Strategies

  1. 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. 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. 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. 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. 5. Why Rapid Enrollment is Not Only Important – It is Critical
  6. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 20. $ THE RACE IS ON $
  21. 21. Let Us Never Forget <ul><li>The most important reason </li></ul><ul><li>“ The Patient is Waiting” </li></ul>
  22. 22. How to Know When to Plan
  23. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 39. When to Plan? As soon as you begin to write the development program
  40. 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. 41. Must not burn recruitment budget Must be Band-aiding again
  42. 42. Thank You Questions?

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