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Cancer Clinical Trials:
In-Depth Information
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The Drug Development andApproval 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
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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 peopleDoes treatment do what it is supposed to?
How does treatment affect the body?
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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 andeffectiveness of new treatment
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Types of Clinical Trials
Treatment
Prevention
Screening and early detection
Diagnostic
Genetics
Quality-of-life / supportive care
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Treatment Trials
Test safety and effectiveness
of new agents or interventionsin people with cancer
Possible benefit:
Early access to new treatments Possible risk:
Occurrence of unknown side
effects
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Prevention Trials
For people at risk of developing
cancer Action studies vs. agent studies
Possible benefit:
Early access to newinterventions
Possible risk:
Unknown side effects and
effectiveness
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Screening and Early-Detection Trials Assess new means of detecting cancer earlier
in healthy people Possible benefit:
Detecting disease at an earlier stage, resulting inimproved outcomes
Possible risks:Discomfort and inconvenience
If imaging technique is studied, exposure to x-rays or radioactive substances
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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
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Genetics Trials
These trials seek to:
Determine how ones genetic makeup caninfluence detection, diagnosis, prognosis, and
treatment
Broaden understanding of causes of cancerDevelop targeted treatments based on the genetics
of a tumor
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Quality-of-Life / Supportive CareTrials
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
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Clinical Trial Protocol
A written, detailed action plan that:
Provides background about the trial
Specifies trial objectives
Describes trials design and organization
Ensures that trial procedures are consistently
carried out
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Investigational Drug UseOutside of a Clinical Trial
Group C drugs
Treatment Investigational New Drug
application
Compassionate use program
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Clinical Trial Design Eligibility criteria: Can range from general
(age, sex, type of cancer) to specific (priortreatment, tumor characteristics, blood cellcounts, organ function); eligibility criteria alsovary with trial phase
Varies with protocol and phases Endpoint: Measurable outcome that indicates
an interventions effectiveness
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Clinical Trial Design
Randomization: A method used to prevent
bias in research; a computer or a table ofrandom numbers generates treatmentassignments, and participants have an equalchance to be assigned to one of two or more
groups (e.g., the control group or theinvestigational group)
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Randomization
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Clinical Trial Design
Stratification: Categorizing subjects into
subgroups by specific characteristicsEnables researchers to look into separate
subgroups to see whether differences exist
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Stratification
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The Final Step: FDA Approval
Review of New Drug Application (NDA) or
Biologics License Application (BLA) Labeling
Continued monitoring
Feedback
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Releasing the Resultsof Clinical Trials
Peer-reviewed journals
Public announcements
Results not made public until end of trial
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Improving Cancer Prevention,Detection, and Treatment
Once proven safe and effective in a clinical trial,an intervention may become the new standard of
care
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Advancing Cancer Care
Gleevec for chronic myelogenous leukemia
Cervical cancer: improved survival rates Breast cancer: less extensive surgery
Intron-A for melanoma
Biological therapy Monoclonal antibodies
Cancer vaccines
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Evolution of Participant Protection
Nuremberg
Tuskegee Syphilis Study
National Commission for the Protection ofHuman Subjects of Biomedical and Behavioral
Research Belmont Report
National Research Act
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Government Oversight ofSafeguards for Participants
Office for Human Research Protections
(OHRP)
The Common Rule
FDA Regulations
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Protecting ParticipantsBefore a Trial
Scientific review by sponsoring organization
Institutional review board approval
Informed consent
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Protecting ParticipantsDuring a Clinical Trial
Institutional review boards (IRBs) Data and safety monitoring boards (DSMBs)
Minimize risks
Ensure integrity of data
Can stop study if necessary
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Barriers to, Benefits of, andRisks of Participation in Clinical
Trials
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Barriers to Adult Participation inClinical Trials
Physicians and other health professionals may: Be unaware of appropriate trials
Be unwilling to lose control of patients care
Believe that standard therapy is best Believe that clinical trials are more work
Harbor concerns about the patients care or
how the person will react to suggestion of
clinical trial participation
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Barriers to Adult Participation inClinical Trials
Patients may: Be unaware of clinical trials
Lack access to trials
Fear, distrust, or be suspicious of research
Have practical or personal obstacles
Face insurance or cost problems
Be unwilling to go against their physicians
wishes
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Benefits of Participating inClinical Trials
Early access to new treatments
Active role in own health care
Participation in advancing medical knowledge
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Risks of Participatingin Clinical Trials
New treatments are not always better thanstandard care
Unexpected side effects
May not work for everyone
Additional cost
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NCI-SponsoredClinical Trial Programs
Clinical Trials Cooperative Group Program Clinical Trials Support Unit (CTSU)
Community Clinical Oncology Program (CCOP)
Minority-Based Community Clinical OncologyProgram
Cancer Centers Program
Clinical Grants Program
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Referring Patients to ClinicalTrials
Health care professionals should know:
Trial objectives
Eligibility criteria
Treatment and prevention options
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Locating NCI Clinical Trialsin the Community
NCI clinical trial registry:
Nations most comprehensive resource on
cancer clinical trials
www.cancer.gov
1-800-4-CANCER (1-800-422-6237)