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Cancer Clinical Trials


Cancer Clinical Trials. In-Depth Information. 2. The Drug Development and Approval Process ... for chronic myelogenous leukemia. Cervical cancer: improved ... – PowerPoint PPT presentation

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Title: Cancer Clinical Trials

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 ones 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

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

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

Investigational Drug UseOutside of a Clinical
  • Group C drugs
  • Treatment Investigational New Drug application
  • Compassionate use program

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
  • Varies with protocol and phases
  • Endpoint Measurable outcome that indicates an
    interventions effectiveness

Clinical Trial Design
  • Randomization A method used to prevent bias in
    research a computer or a table of random numbers
    generates treatment assignments, and participants
    have an equal chance to be assigned to one of two
    or more groups (e.g., the control group or the
    investigational group)

Clinical Trial Design
  • Stratification Categorizing subjects into
    subgroups by specific characteristics
  • Enables researchers to look into separate
    subgroups to see whether differences exist

The Final Step FDA Approval
  • Review of New Drug Application (NDA) or Biologics
    License Application (BLA)
  • Labeling
  • Continued monitoring
  • Feedback

Releasing the Results of Clinical Trials
  • Peer-reviewed journals
  • Public announcements
  • Results not made public until end of trial

Improving Cancer Prevention, Detection, and
  • Once proven safe and effective in a clinical
    trial, an intervention may become the new
    standard of care

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

Evolution of Participant Protection
  • Nuremberg
  • Tuskegee Syphilis Study
  • National Commission for the Protection of Human
    Subjects of Biomedical and Behavioral Research
  • Belmont Report
  • National Research Act

Government Oversight of Safeguards for
  • Office for Human Research Protections (OHRP)
  • The Common Rule
  • FDA Regulations

Protecting Participants Before a Trial
  • Scientific review by sponsoring organization
  • Institutional review board approval
  • Informed consent

Protecting Participants During a Clinical Trial
  • Institutional review boards (IRBs)
  • Data and safety monitoring boards (DSMBs)
  • Minimize risks
  • Ensure integrity of data
  • Can stop study if necessary

Barriers to, Benefits of, and Risks of
Participation in Clinical Trials
Barriers to Adult Participation in Clinical 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

Barriers to Adult Participation in Clinical 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

Benefits of Participating in Clinical Trials
  • Early access to new treatments
  • Active role in own health care
  • Participation in advancing medical knowledge

Risks of Participating in Clinical Trials
  • New treatments are not always better than
    standard care
  • Unexpected side effects
  • May not work for everyone
  • Additional cost

NCI-Sponsored Clinical Trial Programs
  • Clinical Trials Cooperative Group Program
  • Clinical Trials Support Unit (CTSU)
  • Community Clinical Oncology Program (CCOP)
  • Minority-Based Community Clinical Oncology
  • Cancer Centers Program
  • Clinical Grants Program

Referring Patients to Clinical Trials
  • Health care professionals should know
  • Trial objectives
  • Eligibility criteria
  • Treatment and prevention options

Locating NCI Clinical Trials in the Community
  • NCI clinical trial registry
  • Nations most comprehensive resource on cancer
    clinical trials
  • 1-800-4-CANCER (1-800-422-6237)
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