癌症临床试验(册英文版）.pptVIP

Cancer Clinical Trials In-Depth Information The Drug Development and Approval Process 1. Early research and preclinical testing 2. IND application filed with FDA 3. Clinical trials (phases 1, 2, and 3) 4. NDA filed with FDA 5. FDA validates claim and approves drug Phases of Clinical Trials Phase 1: 15-30 people What dosage is safe? How should treatment be given? How does treatment affect the body? Phase 2: Less than 100 people Does treatment do what it is supposed to? How does treatment affect the body? Phases of Clinical Trials Phase 3: From 100 to thousands of people Compare new treatment with current standard Phase 4: From hundreds to thousands of people Usually takes place after drug is approved Used to further evaluate long-term safety and effectiveness of new treatment Types of Clinical Trials Treatment Prevention Screening and early detection Diagnostic Genetics Quality-of-life / supportive care Treatment Trials Test safety and effectiveness of new agents or interventions in people with cancer Possible benefit: Early access to new treatments Possible risk: Occurrence of unknown side effects Prevention Trials For people at risk of developing cancer Action studies vs. agent studies Possible benefit: Early access to new interventions Possible risk: Unknown side effects and effectiveness Screening and Early-Detection Trials Assess new means of detecting cancer earlier in healthy people Possible benefit: Detecting disease at an earlier stage, resulting in improved outcomes Possible risks: Discomfort and inconvenience If imaging technique is studied, exposure to x-rays or radioactive substances Diagnostic Trials Develop better tools for classifying types and phases of cancer and managing patient care Possible benefits: New technology may be better and less invasive Earlier detection of recurrences Possible risk: May require people to take multiple tests Genetics Trials These trials seek to: Determine how one’s genetic makeup can influence detection, diagnosis,