Related Experiment Videos
[Health related quality of life and endpoints in oncology]
1Unité de Biostatistiques et d'Epidémiologie, EA 4184, Plateforme de Recherche Clinique Qualité de vie et Cancer, Centre Georges-François-Leclerc, 1 rue du Pr-Marion, 21079 Dijon cedex, France. fbonnetain@cgfl.fr
Abstract:
In order to perform a clinical trial in oncology, the choice of the primary endpoint is a major concern, not only for sample size calculation but also regarding the clinical meaning of the results which represents treatment utility for patients or public health system. Endpoints could be classified in two categories: "clinical endpoints" including overall survival and health related quality of life (QoL); "biological markers" including, for example, progression free survival (PFS). If conceptual and methodological limits of quality of life are well identified with dedicated researches, limits of progression free survival remain less targeted and known by clinicians. Numerous clinical trials having only demonstrated a progression free survival benefit could be discussed according to clinical benefit. In this context, quality of life constitutes an available and a useful alternative endpoint for trials to ensure treatment benefit in a patient or public health point of view. As quality of life, methodological researches should be pursued to improve scientific robustness for assessments and analyses of progression free survival.
Related Concept Videos
Cancer Survival Analysis
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Kaplan-Meier Approach
Guidelines for Writing Outcome
Patient outcomes reflect the patient's response to the goal rather than what the nurse aims to achieve. Terminology should be observable and measurable to avoid the reader's interpretation. The desired outcome should be realistic and achievable in the designated care timeframe. Expected outcomes should align with adjunctive therapies. The outcome should enhance care evaluation by...
Nursing Ethical Principles II
Consider the following scenario, which illustrates how these principles are applied in the care of Mr. John, a fifty-year-old teacher diagnosed with metastatic liver cancer.
Initially, Mr. John's cancer...
Levels of Health Promotion and Illness Prevention
In primary prevention, actions taken before disease onset prevent the disease from...