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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00073040 | Other Identifier | Advarra |
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This study is a multisite, minimal risk, non-interventional study using patient electronic health record data collected as part of standard of care to answer cohort-based research questions and create robust real-world data sets.
One key purpose of the Study is to collect data that may be used for a wide range of scientific questions and real-world insights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with cancer | No intervention or sample collection is required on the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Provide RWD/E Datasets to Research Collaborators to Support Development | Use data analysis to enable deeper understanding of patient population characteristics and outcomes to more accurately assess clinical trial feasibility and optimize trial design. | 5 years |
| Provide RWD/E Datasets to Research Collaborators to Support Regulatory | Use data analysis to generate supplemental data for new accelerated approval pathway filings and provide real world control arms where necessary. | 5 years |
| Provide RWD/E Datasets to Research Collaborators to Support Commercialization | Use data analysis to enable more precise characterization of biomarker testing rates, factors influencing access to testing, and uptake of recently approved therapies to inform commercial strategy for pharmaceutical companies and generate evidence for payors. | 5 years |
| Provide RWD/E Datasets to Research Collaborators to Support Phase IV Surveillance | Use data analysis to support post approval understanding of longer term side effects that may not be sufficiently detected via randomized clinical trials. | 5 years |
| Provide RWD/E Datasets to Research Collaborators to Support Real-World Insights | Use data analysis to further understanding of variations in patient care across the US to help ensure patients have access to optimal testing and treatment. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
- None
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The population of subjects targeted are: 1) those who have cancer, and 2) those for whom medical records are available.
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Rhodes, MD | Tempus AI, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Health Services | Fountain Valley | California | 98708 | United States | ||
| Cancer Specialists of Northern Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Thomas M. Pharma and the benefits of Real World Data. Drug Discovery World (DDW). Published November 4, 2021. Accessed May 5, 2023. https://www.ddw-online.com/trends-analysis-pharma-and-the-benefits-of-real-world-data-13702-202111/ | ||
| Background | Office of the Commissioner. Oncology Real World Evidence Program. U.S. Food and Drug Administration. Accessed May 5, 2023. https://www.fda.gov/about-fda/oncology-center-excellence/oncology-real-world-evidence-program | ||
| Background | Grayson N. Real-world data can help make better drugs and do it faster. STAT. Published May 2, 2018. Accessed May 5, 2023. https://www.statnews.com/2018/05/02/real-world-data-drug-development/ | ||
| 32011317 | Background | Rudrapatna VA, Butte AJ. Opportunities and challenges in using real-world data for health care. J Clin Invest. 2020 Feb 3;130(2):565-574. doi: 10.1172/JCI129197. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Jacksonville |
| Florida |
| 32256 |
| United States |
| Hawaii Cancer Care | Honolulu | Hawaii | 96813 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Northwest Oncology and Hematology | Rolling Meadows | Illinois | 60008 | United States |
| Community Health Network | Indianapolis | Indiana | 46256 | United States |
| Southcoast Centers for Cancer Care | Fairhaven | Massachusetts | 02719 | United States |
| Sanford Fargo | Fargo | North Dakota | 58102 | United States |
| Taylor Cancer Research Center | Maumee | Ohio | 43537 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |