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