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[How shall we set priorities among experimental treatment methods?]
O F Norheim1, O Ekeberg, S A Evensen
1Cand Med, Senter for medisinsk etikk, Oslo.
Abstract:
There is an increasing demand from patients to have access to new and promising treatment for severe diseases. Norway has recently started ordinary public funding of large-scale clinical investigation of treatment effect and safety for new treatment modalities. The government has thus established a new principle for funding a sub-category of clinical research: investigational medicine. How should we prioritize between promising clinical protocols when resources are scarce? The article examines criteria for priority setting in investigational medicine: quality of evidence; magnitude of expected benefit from treatment; balance between risks and benefits; quality of the research protocol; cost; and size of patient population. These criteria are applied on a controversial clinical examples, high-dose chemotherapy with hematopoietic stem cell support for metastatic breast cancer.
Insights
Prioritizing investigational medicine requires balancing evidence quality, patient benefit, and risks. Scarce resources necessitate careful evaluation of clinical protocols, using criteria like cost and patient population size.
Area of Science:
- Clinical Research
- Oncology
- Health Economics
Context:
- Growing patient demand for novel treatments for severe diseases.
- Norway's new public funding for large-scale clinical investigations of treatment effect and safety.
- Establishment of a funding principle for investigational medicine.
Purpose:
- To examine criteria for prioritizing clinical protocols in investigational medicine.
- To address the challenge of allocating scarce resources effectively.
- To apply prioritization criteria to a controversial case: high-dose chemotherapy for metastatic breast cancer.
Summary:
- Key criteria for prioritization include quality of evidence, magnitude of expected benefit, risk-benefit balance, protocol quality, cost, and patient population size.
- These criteria provide a framework for making difficult decisions in investigational medicine funding.
- The article uses high-dose chemotherapy with hematopoietic stem cell support for metastatic breast cancer as a case study.
Impact:
- Provides a framework for evidence-based decision-making in investigational medicine.
- Aims to optimize resource allocation for promising, yet unproven, treatments.
- Facilitates informed prioritization of clinical research protocols in healthcare systems.