1、Cancer Clinical TrialsIn-Depth Information2The Drug Development and Approval Process1.Early research and preclinical testing2.IND application filed with FDA3.Clinical trials(phases 1,2,and 3)4.NDA filed with FDA5.FDA validates claim and approves drug3Phases of Clinical Trials Phase 1:15-30 people Wh
2、at 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?4Phases of Clinical Trials Phase 3:From 100 to thousands of people Compare new treatment with current standard P
3、hase 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 treatment5Types of Clinical Trials Treatment Prevention Screening and early detection Diagnostic Genetics Quality-of-life/supportive care6Treatmen
4、t 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 effects7Prevention Trials For people at risk of developing cancer Action studies vs.agent studies Possible benefit:Earl
5、y access to new interventions Possible risk:Unknown side effects and effectiveness8Screening 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 i
6、nconvenience If imaging technique is studied,exposure to x-rays or radioactive substances9Diagnostic 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 Poss
7、ible risk:May require people to take multiple tests10Genetics 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 tumor11Quality-of-Lif
8、e/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 participation12Clinical Trial ProtocolA written,detailed action plan that:Provides background about the trial Specifies trial obje
9、ctives Describes trials design and organization Ensures that trial procedures are consistently carried out13Investigational Drug UseOutside of a Clinical Trial Group C drugs Treatment Investigational New Drug application Compassionate use program14Clinical Trial Design Eligibility criteria:Can range
10、 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 15Clinical Trial Design R
11、andomization: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)16Randomization17Clinical Trial Design
12、Stratification:Categorizing subjects into subgroups by specific characteristics Enables researchers to look into separate subgroups to see whether differences exist18Stratification19The Final Step:FDA Approval Review of New Drug Application(NDA)or Biologics License Application(BLA)Labeling Continued
13、 monitoring Feedback20Releasing the Results of Clinical Trials Peer-reviewed journals Public announcements Results not made public until end of trial21Improving Cancer Prevention,Detection,and TreatmentOnce proven safe and effective in a clinical trial,an intervention may become the new standard of
14、care22Advancing 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 vaccines23Evolution of Participant Protection Nuremberg Tuskegee Syphilis Study Nati
15、onal Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Belmont Report National Research Act24Government Oversight of Safeguards for Participants Office for Human Research Protections(OHRP)The Common Rule FDA Regulations25Protecting Participants Before a Trial Scie
16、ntific review by sponsoring organization Institutional review board approval Informed consent26Protecting 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 necessaryBarriers to,Benef
17、its of,and Risks of Participation in Clinical Trials28Barriers to Adult Participation in Clinical TrialsPhysicians 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
18、more work Harbor concerns about the patients care or how the person will react to suggestion of clinical trial participation29Barriers to Adult Participation in Clinical TrialsPatients may:Be unaware of clinical trials Lack access to trials Fear,distrust,or be suspicious of research Have practical o
19、r personal obstacles Face insurance or cost problems Be unwilling to go against their physicians wishes30Benefits of Participating in Clinical Trials Early access to new treatments Active role in own health care Participation in advancing medical knowledge31Risks of Participating in Clinical Trials
20、New treatments are not always better than standard care Unexpected side effects May not work for everyone Additional cost32NCI-Sponsored Clinical Trial Programs Clinical Trials Cooperative Group Program Clinical Trials Support Unit(CTSU)Community Clinical Oncology Program(CCOP)Minority-Based Communi
21、ty Clinical Oncology Program Cancer Centers Program Clinical Grants Program33Referring Patients to Clinical TrialsHealth care professionals should know:Trial objectives Eligibility criteria Treatment and prevention options34Locating NCI Clinical Trials in the CommunityNCI clinical trial registry:Nations most comprehensive resource on cancer clinical trials www.cancer.gov 1-800-4-CANCER(1-800-422-6237)
