Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals.
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Summary
The estimates should be interpreted with caution because confounding cannot be excluded and the statistical power and capacity to adjust for or match on potential confounder variables limited.
- Type
- article
- Published
- 2015-12-01
- Cited by
- 340
- References
- 6
- OpenAlex
- https://openalex.org/W1810662963
- Semantic Scholar
- https://api.semanticscholar.org/CorpusID:41192113
Keywords
Medicine, Surrogate endpoint, Endpoint Determination, Cancer drugs, End point
References
- The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses.
- Increased risk for demyelinating diseases in patients with inflammatory bowel disease.
- Association between tumor necrosis factor-α antagonists and risk of cancer in patients with inflammatory bowel disease.
- Inflammatory neurological disease in patients treated with tumor necrosis factor alpha inhibitors
- Inflammatory bowel disease and demyelination: more than just a coincidence?
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- Trends in Utilization of Surrogate Endpoints in Contemporary Cardiovascular Clinical Trials.
- Access to new cancer medicines in Australia: dispelling the myths and informing a public debate
- Relationship of Industry Sponsorship to Results of Cost-effectiveness Analyses of Drugs Used in Breast Cancer Treatment.
- Balancing Accelerated Approval for Drugs With Accelerated Withdrawal--Reply.
- Balancing Accelerated Approval for Drugs With Accelerated Withdrawal.
- Did It Matter That the Cancer Drugs Fund Was Not NICE? A Retrospective Review.
- Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration’s Approval of Oncology Drugs
- The UK Cancer Drugs Fund Experiment and the US Cancer Drug Cost Problem: Bearing the Cost of Cancer Drugs Until It Is Unbearable.
- An Appraisal of Clinically Meaningful Outcomes Guidelines for Oncology Clinical Trials
- Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.
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- NEGOTIATING LIMITS TO THE FUNDING OF HIGH COST CANCER MEDICINES
- The Use of Surrogate and Patient-Relevant Endpoints in Outcomes-Based Market Access Agreements
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