CLINICALTRIALS：临床试验.pptVIP

CLINICAL TRIALS LEARNING OBJECTIVES Leaner should learn at the end of this lecture What s a clinical trial How many types f clinical trials are available How to conduct a clinical trial PERFORMANCE OBJECTIVES Leaner should be able to perform a clinical trial either in hospital or community setting whenever he faces a doubt regarding benefits of any intervention / drug safety or efficacy WHAT IS IT? It is an experimental epidemiological method. It is an interventional study on individuals, usually on patients. WHAT IS IT? A research study in human volunteers to answer a specific health question WHY THEY ARE DONE? As they provide better evidence of the effect or the outcome that cannot be obtained with any other observational method. The variation is minimized and bias is controlled , hence more valid and their results speak truth. WHY THEY ARE DONE? 3. Enjoying maximum confidence just like any other scientific laboratory experiment 4. Providing maximum amount of assurance 5. Fastest and safest way to find treatments that work in people and ways to improve health WHAT ARE ITS OBJECTIVES? Intervention trials determine whether experimental treatments or trials are safe and effective under controlled environments Observation trials address health issues in large groups of people in natural settings. WHEN THEY ARE DONE When the laboratory and animal studies yield the most promising results of the intervention, those results are tested by clinical trials WHEN THEY ARE DONE When the margin of the expected benefit or the outcome of an intervention is doubtful or very narrow (10to30%) only. When the margin is large, obvious and beyond doubt, it will be unnecessary to conduct clinical trials. WHAT ARE ITS TYPES? Treatment trials Prevention trials Diagnostic trials Screening trials Quality of life trials TREATMENT TRIALS They test New treatments New combination of drugs New approaches to Surgery New Radiation therapy PREVENTION TRIALS They try to