癌癥臨床試驗(yàn)英文版課件

1、Cancer Clinical TrialsIn-Depth Information1The 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 drug2Phases of Clinical TrialsPhase 1: 15-30 p

2、eopleWhat 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?3Phases of Clinical TrialsPhase 3: From 100 to thousands of peopleCompare new treatment with current stan

3、dardPhase 4: From hundreds to thousands of peopleUsually takes place after drug is approvedUsed to further evaluate long-term safety and effectiveness of new treatment4Types of Clinical TrialsTreatmentPreventionScreening and early detectionDiagnosticGeneticsQuality-of-life / supportive care5Treatmen

4、t TrialsTest safety and effectiveness of new agents or interventions in people with cancer Possible benefit:Early access to new treatmentsPossible risk:Occurrence of unknown side effects6Prevention TrialsFor people at risk of developing cancerAction studies vs. agent studiesPossible benefit:Early ac

5、cess to new interventionsPossible risk:Unknown side effects and effectiveness7Genetics TrialsThese trials seek to:Determine how ones genetic makeup can influence detection, diagnosis, prognosis, and treatmentBroaden understanding of causes of cancerDevelop targeted treatments based on the genetics o

6、f a tumor10Quality-of-Life / Supportive Care TrialsAim to improve quality of life for patients and their familiesPossible benefit:Early access to new treatmentPossible risk:May not benefit from participation11Clinical Trial ProtocolA written, detailed action plan that:Provides background about the t

7、rialSpecifies trial objectivesDescribes trials design and organizationEnsures that trial procedures are consistently carried out12Randomization16Clinical Trial DesignStratification: Categorizing subjects into subgroups by specific characteristicsEnables researchers to look into separate subgroups to

8、 see whether differences exist17Stratification18The Final Step: FDA ApprovalReview of New Drug Application (NDA) or Biologics License Application (BLA)LabelingContinued monitoringFeedback19Improving Cancer Prevention, Detection, and TreatmentOnce proven safe and effective in a clinical trial, an int

9、ervention may become the new standard of care21Advancing Cancer CareGleevec for chronic myelogenous leukemiaCervical cancer: improved survival ratesBreast cancer: less extensive surgeryIntron-A for melanomaBiological therapyMonoclonal antibodiesCancer vaccines22Evolution of Participant ProtectionNur

10、embergTuskegee Syphilis StudyNational Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchBelmont ReportNational Research Act23Government Oversight of Safeguards for ParticipantsOffice for Human Research Protections (OHRP)The Common RuleFDA Regulations24Protecting Pa

11、rticipants Before a TrialScientific review by sponsoring organizationInstitutional review board approvalInformed consent25Protecting Participants During a Clinical TrialInstitutional review boards (IRBs)Data and safety monitoring boards (DSMBs)Minimize risksEnsure integrity of dataCan stop study if

12、necessary26Barriers to, Benefits of, and Risks of Participation in Clinical Trials27Barriers to Adult Participation in Clinical TrialsPhysicians and other health professionals may:Be unaware of appropriate trialsBe unwilling to lose control of patients careBelieve that standard therapy is bestBeliev

13、e that clinical trials are more workHarbor concerns about the patients care or how the person will react to suggestion of clinical trial participation28Barriers to Adult Participation in Clinical TrialsPatients may:Be unaware of clinical trialsLack access to trialsFear, distrust, or be suspicious of

14、 researchHave practical or personal obstaclesFace insurance or cost problemsBe unwilling to go against their physicians wishes29Benefits of Participating in Clinical TrialsEarly access to new treatmentsActive role in own health careParticipation in advancing medical knowledge30Risks of Participating

15、 in Clinical TrialsNew treatments are not always better than standard careUnexpected side effectsMay not work for everyoneAdditional cost31NCI-Sponsored Clinical Trial ProgramsClinical Trials Cooperative Group ProgramClinical Trials Support Unit (CTSU)Community Clinical Oncology Program (CCOP)Minority-Based Community Clinical Oncology ProgramCancer Centers ProgramClinical Grants Program32Referring Patients to Clinical TrialsHealth care professionals shoul