癌症临床试验(英文版)
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癌症临床试验(英文版）
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
– New technology may be better and less invasive – Earlier detection of recurrences
• Possible risk:
– May require people to take multiple tests
9
Genetics Trials
– Does treatment do what it is supposed to? – How does treatment affect the body?
3
Phases of Clinical Trials
• Phase 3: From 100 to thousands of people
2
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
– Early access to new interventions
• Possible risk:
– Unknown side effects and effectiveness
7
Screening and Early-Detection Trials
• Assess new means of detecting cancer earlier in healthy people
radioactive substances
8
Diagnostic Trials
• Develop better tools for classifying types and phases of cancer and managing patient care
• Possible benefits:
5
Treatment Trials
• Test safety and effectiveness of new agents or interventions in people with cancer
• Possible benefit:
– Early access to new treatments
• 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
– 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
10
Quality-of-Life / Supportive Care Trials
• Aim to improve quality of life for patients and their families
• Possible benefit: – Early access to new treatment
• Possible risk: – May not benefit from participation
11
Clinical Trial Protocol
A written, detailed action plan that: • Provides background about the trial • Specifies trial objectives • Describes trial’s design and organization • Ensures that trial procedures are
• Poபைடு நூலகம்sible risk:
– Occurrence of unknown side effects
6
Prevention Trials
• For people at risk of developing cancer
• Action studies vs. agent studies • Possible benefit:
• These trials seek to: – Determine how one’s genetic makeup can influence detection, diagnosis, prognosis, and treatment – Broaden understanding of causes of cancer – Develop targeted treatments based on the genetics of a tumor
effectiveness of new treatment
4
Types of Clinical Trials
• Treatment • Prevention • Screening and early detection • Diagnostic • Genetics • Quality-of-life / supportive care
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
– New technology may be better and less invasive – Earlier detection of recurrences
• Possible risk:
– May require people to take multiple tests
9
Genetics Trials
– Does treatment do what it is supposed to? – How does treatment affect the body?
3
Phases of Clinical Trials
• Phase 3: From 100 to thousands of people
2
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
– Early access to new interventions
• Possible risk:
– Unknown side effects and effectiveness
7
Screening and Early-Detection Trials
• Assess new means of detecting cancer earlier in healthy people
radioactive substances
8
Diagnostic Trials
• Develop better tools for classifying types and phases of cancer and managing patient care
• Possible benefits:
5
Treatment Trials
• Test safety and effectiveness of new agents or interventions in people with cancer
• Possible benefit:
– Early access to new treatments
• 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
– 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
10
Quality-of-Life / Supportive Care Trials
• Aim to improve quality of life for patients and their families
• Possible benefit: – Early access to new treatment
• Possible risk: – May not benefit from participation
11
Clinical Trial Protocol
A written, detailed action plan that: • Provides background about the trial • Specifies trial objectives • Describes trial’s design and organization • Ensures that trial procedures are
• Poபைடு நூலகம்sible risk:
– Occurrence of unknown side effects
6
Prevention Trials
• For people at risk of developing cancer
• Action studies vs. agent studies • Possible benefit:
• These trials seek to: – Determine how one’s genetic makeup can influence detection, diagnosis, prognosis, and treatment – Broaden understanding of causes of cancer – Develop targeted treatments based on the genetics of a tumor
effectiveness of new treatment
4
Types of Clinical Trials
• Treatment • Prevention • Screening and early detection • Diagnostic • Genetics • Quality-of-life / supportive care