Related Experiment Videos
[Evaluation and significance of study endpoints--implications for evidence-based decisions in healthcare]
1Gemeinsamer Bundesausschuss, Abteilung Fachberatung Medizin, Berlin. Fachberatung-Medizin@g-ba.de
Abstract:
The Federal Joint Committee (G-BA) is the most important decision-making body within the self-governing German healthcare system. The G-BA assessment of medical treatments and procedures follows a standardised procedure that rests on evidence-based medicine. As a rule, randomised controlled trials with patient-relevant endpoints (in particular mortality, morbidity, quality of life) are required for benefit assessments. Under certain conditions adequate studies with valid surrogate endpoints or composite endpoints may be taken into account in exceptional cases.
Related Concept Videos
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...
Introduction to Epidemiology
Nursing Evaluation
Section...
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...
Clinical Trials
There are four phases in a clinical trial. A phase one...
Bioavailability Study Design: Healthy Subjects Versus Patients