– Does treatment do what it is supposed to? – How does treatment affect the body?
3
Phases of CliniFra bibliotekal Trials
• Phase 3: From 100 to thousands of people
9
Genetics Trials
• 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
5
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
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
13
Clinical Trial Design
• Eligibility criteria: Can range from general (age, sex, type of cancer) to specific (prior treatment, tumor characteristics, blood cell counts, organ function); eligibility criteria also vary with trial phase
– 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
• Possible risks:
– Discomfort and inconvenience – If imaging technique is studied, exposure to x-rays or
radioactive substances
8
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
• 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
effectiveness of new treatment
4
Types of Clinical Trials
• Treatment • Prevention • Screening and early detection • Diagnostic • Genetics • Quality-of-life / supportive care
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
consistently carried out
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Investigational Drug Use Outside of a Clinical Trial
• Group C drugs • Treatment Investigational New Drug
application • Compassionate use program
Cancer Clinical Trials
In-Depth Information
1
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