In Depth Information

7/31/2019 In Depth Information

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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)

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