Standard of Care - Donna Beardsworth


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  • We have actually conducted trials or prepared regulatory documents for each of these indications.
  • Standard of Care - Donna Beardsworth

    1. 1. Standard Of Care Costs in Clinical Trials An Oncology-Focused CRO Perspective Presented by: Donna Beardsworth Founder
    2. 2. Beardsworth – An Oncology-Focused CRO <ul><li>Since 1986 </li></ul><ul><li>NJ-based, WEBENC-Certified, Woman-Owned Business </li></ul><ul><li>Full Service CRO </li></ul><ul><ul><li>Serving Pharma, Biotech, Device, and Diagnostic Companies </li></ul></ul><ul><ul><li>Phases I through 4 </li></ul></ul><ul><ul><li>Regulatory Strategy Consulting, Project Management, Clinical Monitoring, Data Management, Biostatistics, Medical Writing, Safety and Surveillance </li></ul></ul><ul><li>Global Services in Eastern and Western Europe via Beardsworth’s OncologyOne </li></ul>
    3. 3. Therapeutic Area Expertise: Oncology <ul><li>Solid Tumors </li></ul><ul><ul><ul><li>Advanced Tumors </li></ul></ul></ul><ul><ul><ul><li>Brain </li></ul></ul></ul><ul><ul><ul><li>Breast </li></ul></ul></ul><ul><ul><ul><li>Colorectal </li></ul></ul></ul><ul><ul><ul><li>Esophagus </li></ul></ul></ul><ul><ul><ul><li>Head and Neck </li></ul></ul></ul><ul><ul><ul><li>Lung </li></ul></ul></ul><ul><ul><ul><li>Malignant Melanoma </li></ul></ul></ul><ul><ul><ul><li>Ovary </li></ul></ul></ul><ul><ul><ul><li>Prostate </li></ul></ul></ul><ul><ul><ul><li>Renal Cell </li></ul></ul></ul><ul><li>Hematologic Malignancies </li></ul><ul><ul><ul><li>Acute Myelogenous Leukemia </li></ul></ul></ul><ul><ul><ul><li>Chronic Lymphocytic Leukemia </li></ul></ul></ul><ul><ul><ul><li>Hairy Cell Leukemia </li></ul></ul></ul><ul><ul><ul><li>Multiple Myeloma </li></ul></ul></ul><ul><li>Oncology-Related </li></ul><ul><ul><ul><li>Associated Anemia </li></ul></ul></ul><ul><ul><ul><li>Associated Dysphagia </li></ul></ul></ul><ul><ul><ul><li>Associated Xerostomia </li></ul></ul></ul><ul><ul><ul><li>GvHD post BMT </li></ul></ul></ul><ul><ul><ul><li>Quality of Life </li></ul></ul></ul>
    4. 4. Oncology Trial Challenges Today <ul><li>Only 3% of adult cancer patients in the US participate in trials </li></ul><ul><ul><li>There is tremendous competition for these patients </li></ul></ul><ul><ul><li>There is a crisis of perception regarding clinical trial integrity and motivations </li></ul></ul><ul><ul><li>Most trials are NOT completed on time </li></ul></ul><ul><ul><li>US based CROs must have a Global Enrollment Solution </li></ul></ul><ul><li>Costs to Conduct Trials are Escalating </li></ul><ul><ul><li>Trials are complicated and becoming more so </li></ul></ul><ul><ul><li>Endpoints generally require long-term follow-up </li></ul></ul><ul><ul><li>Sponsor, CRO, and Site Grant Costs increase reflecting complexity and long-term nature </li></ul></ul>
    5. 5. SOC Usage <ul><li>TTC recently surveyed 50 companies; asking them to rate the importance of Standard of Care. </li></ul>The Importance of Standard of Care Considerations in Your Company’s Approach to Developing Clinical Grants Very Important 73% Somewhat Important 23% Not Very Important 3% Not At All Important 1% Total 100%
    6. 6. SOC Usage <ul><li>Companies are concerned about fair market value and more effective clinical grant management. </li></ul>Reasons for Using SOC to Incorporate SOC Considerations Percent Avoid paying for procedures covered by third parties 85% Insure paying fair market value by avoiding possible double payment 83% Assist in protocol design 81%
    7. 7. <ul><li>Outside of oncology few companies attempt to achieve the cost savings possible through the incorporation of Standard of Care. </li></ul><ul><ul><li>Nearly two thirds of respondents feel the process is too time-consuming. </li></ul></ul><ul><ul><li>Most express the need for more data. </li></ul></ul><ul><ul><li>Most companies rely upon laborious processes and sources, e.g., sites and internal experts, for information. </li></ul></ul>SOC Usage
    8. 8. Impediments to SOC Usage <ul><li>It may be time-consuming to gather the SOC data from sites, staff experts, and outside experts. </li></ul><ul><li>It may hinder contract negotiations. </li></ul><ul><ul><li>It works in oncology. </li></ul></ul><ul><ul><li>There is no evidence that it slows contract completion in clinical grant management. </li></ul></ul>Why does it work in Oncology?
    9. 9. National Comprehensive Cancer Network <ul><li>NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) </li></ul><ul><ul><li>Recognized standard for clinical policy in oncology </li></ul></ul><ul><ul><ul><li>Most comprehensive and most frequently updated clinical practice guidelines available in any area of medicine </li></ul></ul></ul><ul><ul><ul><li>Covering 97 percent of all patients with cancer and updated on a continual basis </li></ul></ul></ul>
    10. 10. National Comprehensive Cancer Network <ul><li>Consortium of 21 not-for-profit US hospitals and institutions </li></ul><ul><ul><li>Publishes 110 oncology guidelines that are “recognized and applied as the standard of care in the United States” </li></ul></ul><ul><ul><li>Guidelines viewed by over 1 million unique visitors per year. </li></ul></ul><ul><li>According to surveys of oncologists conducted by NCCN and other groups: </li></ul><ul><ul><li>~ 90 percent of oncologists in the US report that they use the NCCN guidelines in their practice frequently or very frequently. </li></ul></ul>
    11. 11. NCCN Guidelines and 3 rd Party Payers <ul><li>March 2010 – NCCN Meeting “Clinical and Economic Issues Impacting Cancer Care Delivery.” </li></ul><ul><li>Aetna Inc. James D. Cross, MD </li></ul><ul><ul><li>Spends upwards of $1.5 billion a year on cancer care </li></ul></ul><ul><ul><li>Uses the NCCN Guidelines as part of its care decisions as well as reimbursement methodology </li></ul></ul><ul><li>UnitedHealthcare </li></ul><ul><ul><li>Spends $3 billion annually on cancer care </li></ul></ul><ul><ul><li>Utilizes the NCCN Guidelines and NCCN Drugs & Biologics Compendium (NCCN Compendium™) to make coverage decisions </li></ul></ul>
    12. 12. Trial Design and Implementation Considerations <ul><li>Protocols </li></ul><ul><ul><li>Patient Visits/Procedures are timed to reflect SOC regimens </li></ul></ul><ul><ul><li>Concomitant Therapies are aligned with SOC </li></ul></ul><ul><li>Budgets and Grants </li></ul><ul><ul><li>Contracts and Budget Grids are Fairly Straightforward </li></ul></ul><ul><ul><ul><li>Costs for the un- or under-insured must be delineated </li></ul></ul></ul><ul><ul><li>Requires Detailed Grant Payment Work </li></ul></ul><ul><ul><ul><li>Procedure Based vs. Visit Based Payments to Sites </li></ul></ul></ul><ul><ul><ul><li>Costs to Process increase </li></ul></ul></ul>
    13. 13. Two Oncology Trials Analyzed
    14. 14. SOC Analysis – Acute Lymphoid Leukemia, Acute Lymphoblastic Leukemia, Leukemia Single Patient Duration 36 Months Number of Visits 34 Number of Patients 22 Number of Procedures 42 Number of SOC Procedures 34 Number of Expensive SOC Procedures 2 Total Cost for Procedures Per Patient before SOC $52,264 USD Total Cost for Procedures Per Patient after SOC $ 34,662 USD Total SOC Savings Per Patient $ 17,602 USD Total SOC Savings for All Patients $ 387, 244 USD Total % of SOC Savings 34 %
    15. 15. SOC Analysis – Ovarian Cancer Single Patient Duration 89 Weeks Number of Visits 163 Number of Patients 360 Number of Procedures 18 Number of SOC Procedures 12 Number of Expensive Procedures 2 Total Cost for Procedures Per Patient before SOC $ 109,423 USD Total Cost for Procedures Per Patient after SOC $91,087 USD Total SOC Savings Per Patient $ 18,336 USD Total SOC Savings for All Patients $6,600,960 USD Total % of SOC Savings 16.8%
    16. 16. Challenges <ul><li>The shift of oncology trial patients from US to other parts of the world </li></ul><ul><ul><li>Different healthcare funding </li></ul></ul><ul><ul><li>Different motivators for trial participation </li></ul></ul>
    17. 17. Why it Works in Oncology <ul><li>In the US, Well-defined, Detailed, Generally Accepted Guidelines exist and are: </li></ul><ul><ul><li>Followed by US oncologists </li></ul></ul><ul><ul><li>Reimbursed by 3 rd Party Payers </li></ul></ul><ul><li>Protocols are built in detail around the Guidelines that define SOC and are in Common Practice </li></ul><ul><li>The Complexity and Duration of Oncology Trials drives costs up </li></ul><ul><ul><li>The SOC impact is considerable </li></ul></ul><ul><ul><ul><li>Trivializes the additional steps required for contract and grant design and management </li></ul></ul></ul>