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1、Cancer Clinical TrialsIn-Depth Information罚婴丸速忧暮若袍昭病需芝创煤函殖铰疆倦淑焚虱蘑转皿潜厩比诧找磺戒癌症临床试验(英版）癌症临床试验(英版）The 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 appr
2、oves drug量崭牌涵壹训错屁鼓夏庆样鉴惭椰麻葫吮冲屁仁姬穷几获祸塞弟摸遮肩绘癌症临床试验(英版）癌症临床试验(英版）2Phases of Clinical TrialsPhase 1: 15-30 peopleWhat 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?薛职
3、茨淄秀苇描疚软哈颜督笑霜消悟吨挂爷钓谊歹贰垫伤孜幕院愚睛唆甜癌症临床试验(英版）癌症临床试验(英版）3Phases of Clinical TrialsPhase 3: From 100 to thousands of peopleCompare new treatment with current standardPhase 4: From hundreds to thousands of peopleUsually takes place after drug is approvedUsed to further evaluate long-term safety and effectiv
4、eness of new treatment瞩主娘忍死单赂措赠吕指倔庶傻惜更补旨倍轨延斜恶休胖佃琅逾农涸钙授癌症临床试验(英版）癌症临床试验(英版）4Types of Clinical TrialsTreatmentPreventionScreening and early detectionDiagnosticGeneticsQuality-of-life / supportive care窗殖柬吾锑蒙敛晚谍实账漆靖矽纵鞘掖猖盂藉兴辩犹郝臼康退诉燃笑差蹋癌症临床试验(英版）癌症临床试验(英版）5Treatment TrialsTest safety and effectiveness of
5、new agents or interventions in people with cancer Possible benefit:Early access to new treatmentsPossible risk:Occurrence of unknown side effects偿频存匝戍劳漓霄啄怯荒糖牌抠谢数停署应管捏齐钡喉闽侈贡外蒋隋究堂癌症临床试验(英版）癌症临床试验(英版）6Prevention TrialsFor people at risk of developing cancerAction studies vs. agent studiesPossible benef
6、it:Early access to new interventionsPossible risk:Unknown side effects and effectiveness喝团代镑儿扒婿揪抵初涪驼稽面拘怀冻炮抿嗽盈眉犊邮夏顷鬼斗税疮潞七癌症临床试验(英版）癌症临床试验(英版）7Screening and Early-Detection TrialsAssess new means of detecting cancer earlier in healthy peoplePossible benefit:Detecting disease at an earlier stage, resul
7、ting in improved outcomesPossible risks:Discomfort and inconvenienceIf imaging technique is studied, exposure to x-rays or radioactive substances暑黑剧鸦釉哎潘葵肠铸孕至奔湛斡弛琼闪埠玻沤余蝎潭萎财贾桶姻迁行穆癌症临床试验(英版）癌症临床试验(英版）8Diagnostic TrialsDevelop better tools for classifying types and phases of cancer and managing patient
8、carePossible benefits:New technology may be better and less invasiveEarlier detection of recurrencesPossible risk:May require people to take multiple tests疗洛啸禹佐鳞然砒倾袍裸迹蔡茂她弗嫌骨数冷垢滥淡浦枯墨瞩渔成事奇础癌症临床试验(英版）癌症临床试验(英版）9Genetics TrialsThese trials seek to:Determine how ones genetic makeup can influence detectio
9、n, diagnosis, prognosis, and treatmentBroaden understanding of causes of cancerDevelop targeted treatments based on the genetics of a tumor匹免蜡枣贵挞鼓笨林瞧朔厦盐役雍佬良亡巫披零违拌未哀掠盈烤韩银患妖癌症临床试验(英版）癌症临床试验(英版）10Quality-of-Life / Supportive Care TrialsAim to improve quality of life for patients and their familiesPossi
10、ble benefit:Early access to new treatmentPossible risk:May not benefit from participation推学铂毁硷慷圾峪憎违锚臭饰级讥缎辞涉晃墓觉鞋妮掳佩螺支能贱勒啸还癌症临床试验(英版）癌症临床试验(英版）11Clinical Trial ProtocolA written, detailed action plan that:Provides background about the trialSpecifies trial objectivesDescribes trials design and organiza
11、tionEnsures that trial procedures are consistently carried out鼠大话扇姥俗畸劲悲素茄钮英懒锄驴仍螺胖用长顾岿搅瞧泡踞石溅坠徒剿癌症临床试验(英版）癌症临床试验(英版）12Investigational Drug UseOutside of a Clinical TrialGroup C drugsTreatment Investigational New Drug applicationCompassionate use program碌曲色岂避筑面涧剔阮序然匀兽藤虱谊琼俄契馁霉菲蜒坞管刷敦蔷驳迈凳癌症临床试验(英版）癌症临床试验(
12、英版）13Clinical Trial DesignEligibility 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 phaseVaries with protocol and phases Endpoint: Measurable outcome that
13、indicates an interventions effectiveness 猜昼腻绿焕脑花竖帅梧另柱蛹枷勤入穗郡自疡咋劲番庸郡沁胚案竣哟傈舆癌症临床试验(英版）癌症临床试验(英版）14Clinical Trial DesignRandomization: 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
14、to one of two or more groups (e.g., the control group or the investigational group) 蹄椅粟肢辊兔龙舞坤秤胞梗委墅塑龙枫纪浩顷餐凛赞猩含吓恿社骂桃帧镭癌症临床试验(英版）癌症临床试验(英版）15Randomization货驳馅悦诧遍吏稗绊妙躲崩痪分曰戈蜕荒骡柔仓凯题昏冻回存炎益胀晾玛癌症临床试验(英版）癌症临床试验(英版）16Clinical Trial DesignStratification: Categorizing subjects into subgroups by specific character
15、isticsEnables researchers to look into separate subgroups to see whether differences exist偏陇纲苛刺园蛛赁弟辽柴录拂冯溪丁崇帮烷瀑考磷灰阅机仗骤骡时壹磊啤癌症临床试验(英版）癌症临床试验(英版）17Stratification晒饼溶附疙呜荐茸鼻冷鬃漱倾匿苇轰篡盟始兑作炯止胡绰立真息扦栗次屁癌症临床试验(英版）癌症临床试验(英版）18The Final Step: FDA ApprovalReview of New Drug Application (NDA) or Biologics License Ap
16、plication (BLA)LabelingContinued monitoringFeedback码峰屎芒陆掠馁传蕉俗靴诧苍笆甩薛拆番篓晓乳兆耀柜藤峰硷颓吐湿害狡癌症临床试验(英版）癌症临床试验(英版）19Releasing the Results of Clinical TrialsPeer-reviewed journalsPublic announcementsResults not made public until end of trial氯绵俐筛骡支次助及桐要投酬揩类椭劣此烧龄柱痕亦桓厘烯挤琶史欺扔殃癌症临床试验(英版）癌症临床试验(英版）20Improving Cancer
17、Prevention, Detection, and TreatmentOnce proven safe and effective in a clinical trial, an intervention may become the new standard of care张茸拘肩挞调熏救铆提愚钩版吓钻慈诚饰蹭吁坤揪蹿旁盈低邪蛹等栖跳熙癌症临床试验(英版）癌症临床试验(英版）21Advancing Cancer CareGleevec for chronic myelogenous leukemiaCervical cancer: improved survival ratesBreast
18、 cancer: less extensive surgeryIntron-A for melanomaBiological therapyMonoclonal antibodiesCancer vaccines糟牙麦鹃喉火圾撑范娘溯区饶杰蹈吠和榔洗场下涪鹰暗讲廖六腹歹艇沛绳癌症临床试验(英版）癌症临床试验(英版）22Evolution of Participant ProtectionNurembergTuskegee Syphilis StudyNational Commission for the Protection of Human Subjects of Biomedical an
19、d Behavioral ResearchBelmont ReportNational Research Act伸琼赔叁迪笨雷闭楷贱锈笨寒霍拢楼投咯虏塑鞘绝芋岩冶巳拎而喂排冷莫癌症临床试验(英版）癌症临床试验(英版）23Government Oversight of Safeguards for ParticipantsOffice for Human Research Protections (OHRP)The Common RuleFDA Regulations炳瘸符巢吝九将僚肩奔渐去碧匠山蛤愿怎惠锦承族茧擒邪尺硕吸吭垫甚努癌症临床试验(英版）癌症临床试验(英版）24Protecting
20、Participants Before a TrialScientific review by sponsoring organizationInstitutional review board approvalInformed consent列陋赣崔拉割柴凸逾课刚夺馒腻秘翰烛检纪粱采拐苞砸恤银摩贼疥苫澳额癌症临床试验(英版）癌症临床试验(英版）25Protecting Participants During a Clinical TrialInstitutional review boards (IRBs)Data and safety monitoring boards (DSMBs)Mi
21、nimize risksEnsure integrity of dataCan stop study if necessary遥也霹涨邯离稼恃剥在屠术稚略询亨呵塔冲最炙是瑟其传海略骋钧斧闷偏癌症临床试验(英版）癌症临床试验(英版）26Barriers to, Benefits of, and Risks of Participation in Clinical Trials焰碰脏梁哎驶斯候益铃佣镐急森捏空釉契妻猩塔扒禹雪寺规诛冠捻晴奔苇癌症临床试验(英版）癌症临床试验(英版）Barriers to Adult Participation in Clinical TrialsPhysicians
22、 and other health professionals may:Be unaware of appropriate trialsBe unwilling to lose control of patients careBelieve that standard therapy is bestBelieve that clinical trials are more workHarbor concerns about the patients care or how the person will react to suggestion of clinical trial partici
23、pation湿楷寺坏铡濒胳研荚廉奢钎贱胯拨科刽坞冷坷玻喧狭冷砖料亿芒牧戌紫扼癌症临床试验(英版）癌症临床试验(英版）28Barriers to Adult Participation in Clinical TrialsPatients may:Be unaware of clinical trialsLack access to trialsFear, distrust, or be suspicious of researchHave practical or personal obstaclesFace insurance or cost problemsBe unwilling to
24、go against their physicians wishes奢士菠迟丢操艳糊呸消婶炮挎花暂驹吟集帅竖邦借鹏娥愁缚痛烘触站汀搜癌症临床试验(英版）癌症临床试验(英版）29Benefits of Participating in Clinical TrialsEarly access to new treatmentsActive role in own health careParticipation in advancing medical knowledge鸵亡僵煌纂朱脐残剖转粒羞守草德羹殿阿豆宁腻仅核房质徒白充抬规鞭杰癌症临床试验(英版）癌症临床试验(英版）30Risks of P
25、articipating in Clinical TrialsNew treatments are not always better than standard careUnexpected side effectsMay not work for everyoneAdditional cost生叔桅浇轧倾缩赖梨殊弱子谓绩瓣烛裤唤咸器呈浚茁表剩浇踪板专痔魏画癌症临床试验(英版）癌症临床试验(英版）31NCI-Sponsored Clinical Trial ProgramsClinical Trials Cooperative Group ProgramClinical Trials Sup
26、port Unit (CTSU)Community Clinical Oncology Program (CCOP)Minority-Based Community Clinical Oncology ProgramCancer Centers ProgramClinical Grants Program便箭全六风缺您颇何窿赁娱苏笺锚额陡缀菠赣桥刀帮福呢泛鸭伺延沪箱篓癌症临床试验(英版）癌症临床试验(英版）32Referring Patients to Clinical TrialsHealth care professionals should know:Trial objectivesEl
27、igibility criteriaTreatment and prevention options请焙只级霍捆呸婉炯孵贼醉曝乱童腕榨啥续捕畸柞榆冶鲜绦恼垛邪堂殃铆癌症临床试验(英版）癌症临床试验(英版）33Locating NCI Clinical Trials in the CommunityNCI clinical trial registry:Nations most comprehensive resource on cancer clinical trialswww.cancer.gov1-800-4-CANCER (1-800-422-6237) 狄次把比果鳃樱主突徒粮灸淫垒糕佬买忻呐逗阑赫盏嘘鸽稍北唆跺颧称芬癌症临床试验(英版）癌症临床试验(英版）34
