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The State of Clinical Development - Globalization


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CROs in Today's Drug Development - Douglas Peddicord January 11, 2012

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The State of Clinical Development - Globalization

  1. 1. The State of Clinical Development - Globalization January 11, 2011 Doug Peddicord, PhD Executive Director
  2. 2. ACRO <ul><li>In 2010, ACRO member companies managed nearly 2 million participants in over 11,500 clinical studies. </li></ul><ul><li>In 2010, ACRO member companies conducted clinical studies in 114 countries across 6 continents. </li></ul><ul><li>ACRO member companies currently employ over 72,000 people worldwide. </li></ul><ul><li>ACRO members contributed to the development of all of top 20 selling drugs </li></ul><ul><ul><li>Member companies were involved in the development of 33 of 38 new drugs approved last year in the US and Europe </li></ul></ul>
  3. 3. The Top CROs (as of 10-16-11) Sources: Scrip INC Kendle Pharmanet I3 InVentiv Health
  4. 4. Major Pharma and CRO Clinical Headcount Source: Tufts CSDD analysis
  5. 5. ACRO Member Company Expansion: 2010
  6. 6. ACRO Member Company Expansion: 2011
  7. 7. Increasing Global Site Dispersion Source: Tufts CSDD analysis of Industry-Funded Trials Registered on 2002-2006 (Mean # of Countries) 2006-2010 (Mean # of Countries) Phase I Clinical Trial 2 2 Phase II Clinical Trial 11 18 Phase III Clinical Trial 19 34
  8. 8. A Global Enterprise – Current and Recently Completed Trials Source:
  9. 9. Why Conduct Clinical Trials Around The World? <ul><li>The answer is in the numbers : when searching for potential research participants (patients) and potential investigators, you can cast your net across 350 million, 700 million or 7 billion </li></ul><ul><li>And in new markets for new biomedical products - with the emergence of middle classes in China and India, for example, the size of the US </li></ul><ul><li>And in improving regulatory and health care infrastructures </li></ul><ul><li>And, temporarily at least, in lower costs </li></ul>
  10. 10. Globalization - Advantages <ul><li>Availability of patients shortens recruitment time (numbers, numbers, numbers) </li></ul><ul><ul><ul><li>Time for cancer trials can be cut in half </li></ul></ul></ul><ul><li>Availability of investigators and site personnel </li></ul><ul><li>Broad adoption of GCP allows consistency </li></ul><ul><li>Research quality standards are consistent worldwide – proof of compliance is required by regulators in every major market </li></ul><ul><li>New markets (safety and efficacy demonstrated for multiple regulators) </li></ul>
  11. 11. Globalization - Challenges <ul><li>Research infrastructure not as developed </li></ul><ul><ul><ul><li>Staff training, equipment, record and drug storage conditions, potential power outages, problems with internet access </li></ul></ul></ul><ul><li>Region specific regulatory hurdles </li></ul><ul><li>Social and cultural issues </li></ul><ul><li>Differences in medical care </li></ul><ul><li>Multiple IRBs/Ethics Committees </li></ul><ul><li>Political instability, travel restrictions </li></ul><ul><li>Question: will regulators find study data acceptable? </li></ul>
  12. 12. Globalization - Concerns <ul><li>Broad social justice issues – testing products for what kinds of diseases and conditions, with what level of transparency, to be made available in what ways to which people, within what kind of health care system? </li></ul><ul><li>Ethics – informed consent, undue inducement, vulnerable populations, language and cultural differences, etc. </li></ul><ul><li>Quality – in the training of investigators and sites, the conduct of the trial, regulatory oversight, the quality of the data, etc. </li></ul><ul><li>Scientific relevance (extrapolatability) </li></ul>
  13. 13. NBAC 2001 Report – selected recommendations <ul><li>FDA should not accept data from trials that do not meet ethics standards </li></ul><ul><li>Studies should be ‘responsive’ to the health needs of the host country </li></ul><ul><li>Community representatives should be involved in design and conduct of trials </li></ul><ul><li>Members of control group should receive established, effective treatment whether available in-country or not </li></ul>
  14. 14. More from NBAC <ul><li>Voluntary informed consent is essential, including information regarding benefits, if any, after the study ends </li></ul><ul><li>Cultural factors must be considered vis-à-vis informed consent </li></ul><ul><li>“ Therapeutic misconception” must be minimized </li></ul><ul><li>Participants should have continued access to experimental interventions proven effective </li></ul><ul><li>Effective interventions should become available to host country population </li></ul>
  15. 15. Going Beyond Business Considerations and Policy Recommendations <ul><li>Let’s do some research – in 2010 ACRO undertook a study of global data quality. We gathered data from 25 multi-country phase 3 studies, with more than 63,000 participants </li></ul><ul><li>We were interested in determining if market maturity in various regions of the world (defined as “mature”, “developed” , and “emerging”) impacts the quality of clinical research data generated in support of FDA and EMA marketing authorization applications, as measured by data base query rates. </li></ul>
  16. 16. Comparison of Participating Sites and Subjects Across Various Regions
  17. 17. Demographic and Other Study Details <ul><li>Number of subjects/study varied from 211 – 26,450; average = 2,612 </li></ul><ul><li>Average number of queries/study = 54,568 </li></ul><ul><li>Average number of queries/subject = 21 </li></ul><ul><li>Average CRF = 114 pages and average number of parameters = 1443 </li></ul><ul><li>Therapeutic Areas: cardiovascular (6), CNS (5), oncology/hematology (4), women’s health (2), </li></ul><ul><li>general medicine (3), endocrine (1), over active bladder (1), anti-infective (1), gastrointestinal </li></ul><ul><li>tract (1) and asthma (1) </li></ul>
  18. 18. Summary of Findings <ul><li>Overall, given the large number of trials, subjects, sites and therapeutic areas included in the analyses, this study represents an attempt at unbiased evaluation of clinical trials data conducted in regions outside mature regions (North America, Western Europe and Japan). </li></ul><ul><li>Primary emphasis was placed on comparing data quality (data errors) for each region against those generated for the North American Region. </li></ul><ul><li>Our analyses indicates that there are no statistically significant differences in the total query rates or in the number of database changes between various regions or when each region was compared to North America. </li></ul>
  19. 19. The Next Research Project: 2011-2012 <ul><li>Global quality at the investigator/site level, i.e., quality in the conduct of the clinical trial for multi-country projects </li></ul><ul><li>Quality of human subject protections: informed consent execution; inclusion/exclusion errors </li></ul><ul><li>Investigator/site training and qualifications: GCP compliance; FDA and other agency inspection and audit findings </li></ul><ul><li>Performance metrics: e.g., time to first patient in; number of patients per site </li></ul>
  20. 20. Assessing Global Quality at the Investigator/Site Level <ul><li>Purpose: Gather data from ACRO member managed multi-regional clinical trial programs to assess:1) ‘quality’ of human subject protections; 2) investigator/site training and other qualifications; 3) site/investigator performance metrics </li></ul><ul><li>Status : Data gathering complete; analysis beginning </li></ul><ul><li>Null Hypothesis : investigator/site quality does not differ significantly between ‘mature’ and ‘non-mature’ countries. </li></ul>
  21. 21. Aligning The Incentives <ul><li>Protection of subjects, adherence to GCPs = valid, reliable data </li></ul><ul><li>Good data (good science) = prompt regulatory review </li></ul><ul><li>Prompt regulatory review = increased approvals for new biomedical products, benefiting all stakeholders </li></ul>
  22. 22. Thank You! <ul><li>Doug Peddicord, PhD </li></ul><ul><li>Executive Director </li></ul><ul><li>[email_address] </li></ul><ul><li> </li></ul>