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[Outcome research: rationales and objectives]
A Olivieri1, G Recchia, F Roila
1Glaxo Wellcome SpA, Verona, Italia.
Abstract:
Outcome research measures the clinical, economic and humanistic outcomes of pharmacological therapies on patients suffering from different diseases. Outcome research can be applied either to phase II and III clinical trials to assess new drugs for registration or to already marketed drugs to assess their real value when used in clinical practice in a large population of patients. Oncology can be a major field of application because there is a large amount of new treatments put on the market, often without demonstration of significant improvement in survival or Quality of Life but with higher prices than the old molecules. Patients and disease specific outcomes have been identified for cancer by a Working Group set up by the American Society of Clinical Oncology, with the former being defined as more critical to establish the value of new treatments. Survival, drug toxicity and impact on Quality of Life are the most important patient's outcomes to consider before recommending anti-cancer therapies for use in clinical practice. The present paper will describe the outcomes in oncology and will deal with the transferability to clinical practice of the results of clinical trials.
Insights
Outcome research evaluates the real-world value of cancer treatments by assessing clinical, economic, and humanistic outcomes. Key patient outcomes like survival, toxicity, and Quality of Life are crucial for guiding clinical practice decisions.
Area of Science:
- Pharmacoeconomics and Health Outcomes Research
- Clinical Oncology
Background:
- Outcome research assesses clinical, economic, and humanistic results of therapies in patient populations.
- Oncology is a key area due to new, expensive cancer treatments often lacking proven survival or Quality of Life benefits.
Purpose of the Study:
- To describe patient and disease-specific outcomes in oncology.
- To evaluate the transferability of clinical trial results to real-world clinical practice.
Main Methods:
- Review of outcome research principles and applications in drug development and clinical practice.
- Identification of critical patient outcomes for anti-cancer therapies.
Main Results:
- Survival, drug toxicity, and Quality of Life are paramount patient outcomes in oncology.
- American Society of Clinical Oncology identified patient-specific outcomes as critical for assessing treatment value.
Conclusions:
- Outcome research is vital for determining the true value of cancer therapies beyond initial registration.
- Assessing survival, toxicity, and Quality of Life is essential for evidence-based clinical recommendations in oncology.