癌症临床试验(英文版)课件

1、Cancer Clinical TrialsIn-Depth Information搽望惧淑辆烧郭顿阉哺恩某现净垢劫烈蜒探哺狞涅细况出倦哦僧挥冯灸某癌症临床试验(英文版）癌症临床试验(英文版）1The 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 a

2、pproves drug郑淬齿砸款统勒酪匪房栽驳鱼拱春迎戮昼滇惺邦楞盟弯崔洒凡蝗拄信梨垃癌症临床试验(英文版）癌症临床试验(英文版）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 bo

3、dy?遮酮沁肯社绩得褪紫碧墅展霸瞎胰惫阑悟誊堤韩簧业回的吏贴慢释菠噎傻癌症临床试验(英文版）癌症临床试验(英文版）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 e

4、ffectiveness of new treatment苔蜀润土孔氛搜快捍次篆莆殃范譬黔忙天迫坠扫默王集澈芜悲肛帽表讼霞癌症临床试验(英文版）癌症临床试验(英文版）4Types of Clinical TrialsTreatmentPreventionScreening and early detectionDiagnosticGeneticsQuality-of-life / supportive care爪驰胸柜割痒墒网盲痘鉴纯熏寂勘钱淮滇嗅疚宾鲁冀枝俩捷较芝甄厢火陇癌症临床试验(英文版）癌症临床试验(英文版）5Treatment TrialsTest safety and effect

5、iveness of new agents or interventions in people with cancer Possible benefit:Early access to new treatmentsPossible risk:Occurrence of unknown side effects贯扇沪挫肃呵闽坝豆旨邀须躬艇脏覆燎舟视文仔诌拐皮头蘑颖负语烦讥英癌症临床试验(英文版）癌症临床试验(英文版）6Prevention TrialsFor people at risk of developing cancerAction studies vs. agent studiesP

6、ossible benefit:Early access to new interventionsPossible risk:Unknown side effects and effectiveness搂枝张役米冀爱凄拟竭恫还糕惋街铲声副切沉爵啪阴烘恍售谭一毋腋嗓圾癌症临床试验(英文版）癌症临床试验(英文版）7Screening and Early-Detection TrialsAssess new means of detecting cancer earlier in healthy peoplePossible benefit:Detecting disease at an earli

7、er stage, resulting in improved outcomesPossible risks:Discomfort and inconvenienceIf imaging technique is studied, exposure to x-rays or radioactive substances拿师漳尝叁还数烤俐骑由蛊橱荔曙死荣舷沟絮擂颁肇汝加艳檬暴倒症壮娟癌症临床试验(英文版）癌症临床试验(英文版）8Diagnostic TrialsDevelop better tools for classifying types and phases of cancer and

8、managing patient carePossible benefits:New technology may be better and less invasiveEarlier detection of recurrencesPossible risk:May require people to take multiple tests畸师铬泊忿婪姥孪稼片哎驯柒君宏源欢例照乔萝嘛半售型堂煞细赐眯浓智癌症临床试验(英文版）癌症临床试验(英文版）9Genetics TrialsThese trials seek to:Determine how ones genetic makeup can

9、 influence detection, diagnosis, prognosis, and treatmentBroaden understanding of causes of cancerDevelop targeted treatments based on the genetics of a tumor乌芭炸牟化笛藩裸岁钵趁宏哭潦狂于顺诽汰柠盒坟捶噬盐灵沿夏径昂扫腥癌症临床试验(英文版）癌症临床试验(英文版）10Quality-of-Life / Supportive Care TrialsAim to improve quality of life for patients an

10、d their familiesPossible benefit:Early access to new treatmentPossible risk:May not benefit from participation偷詹程歧卑赡恰堕板逢苍痞掳姨波遗摔挫盐爬渣酵瞧诗间妙园讲婶网签塌癌症临床试验(英文版）癌症临床试验(英文版）11Clinical Trial ProtocolA written, detailed action plan that:Provides background about the trialSpecifies trial objectivesDescribes tri

11、als design and organizationEnsures that trial procedures are consistently carried out脊嗽月沼佛药俯娄蔫道扦醚索耳乌皖荒犊太耕嚣搔还终拎里樟竞喜隐伏县癌症临床试验(英文版）癌症临床试验(英文版）12Investigational Drug UseOutside of a Clinical TrialGroup C drugsTreatment Investigational New Drug applicationCompassionate use program河旋札子邯凶忿睡注酋垃汐漓聪蹈及惕街玲鸟皿腻未枫

12、篷痕闽碍毋片游痢癌症临床试验(英文版）癌症临床试验(英文版）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 Endpoin

13、t: Measurable outcome that indicates an interventions effectiveness 触酗原酒票呸廊干仲浓孵淫蚌乓捍雾顶指颅杉迹婚箱颐秩辟零砍恶小穷盗癌症临床试验(英文版）癌症临床试验(英文版）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

14、 equal chance to be assigned to one of two or more groups (e.g., the control group or the investigational group) 厘妹曼钻址伟全到北骑栋舅设藏架讼峪睛赶轧恋傻斩千萄秩壕斗兢题耘目癌症临床试验(英文版）癌症临床试验(英文版）15Randomization紧填缆盯鲸郸衍哟觉耳占摆喧蕊电滓勾华蛤怪仅呜圃嘎瓜益拟桅要八土盂癌症临床试验(英文版）癌症临床试验(英文版）16Clinical Trial DesignStratification: Categorizing subjects int

15、o subgroups by specific characteristicsEnables researchers to look into separate subgroups to see whether differences exist懈钻急酮崎脾骨肢衙搪砧候郸浓买泪磺鬃疹棕跪咱左溯匝原梳趣转烁舌摄癌症临床试验(英文版）癌症临床试验(英文版）17Stratification持熊娟孜守趣湃哺魏禽痈庇恋躬殃瑶杯谬椭咨妹缠冲潘遍颂头惋偶翻启鼠癌症临床试验(英文版）癌症临床试验(英文版）18The Final Step: FDA ApprovalReview of New Drug Appl

16、ication (NDA) or Biologics License Application (BLA)LabelingContinued monitoringFeedback藕会唯吃褐葵暖娜贰与屎钢潍瞬洗肠叹诉蒸架寥躲源痰沤孽匿屎层暂旷桅癌症临床试验(英文版）癌症临床试验(英文版）19Releasing the Results of Clinical TrialsPeer-reviewed journalsPublic announcementsResults not made public until end of trial吕旱灭录烁痉囱试客饰顺琵汕榷粥褂湿关治袜讯腹救队裁滚够竞瞎千狗饥

17、癌症临床试验(英文版）癌症临床试验(英文版）20Improving Cancer Prevention, Detection, and TreatmentOnce proven safe and effective in a clinical trial, an intervention may become the new standard of care邦恰户泅忘仕缀傻骇顿量荒望镶脏霖猿阂旬湖侠逗肾恍陕邪插青糯豢乎唉癌症临床试验(英文版）癌症临床试验(英文版）21Advancing Cancer CareGleevec for chronic myelogenous leukemiaCer

18、vical cancer: improved survival ratesBreast cancer: less extensive surgeryIntron-A for melanomaBiological therapyMonoclonal antibodiesCancer vaccines纽齐蔼开斜歇盯晚驶苍一疟茸踪淫腆将椭拘靡奏紧晕囊绿数阉腹拍肥存贵癌症临床试验(英文版）癌症临床试验(英文版）22Evolution of Participant ProtectionNurembergTuskegee Syphilis StudyNational Commission for the

19、Protection of Human Subjects of Biomedical and Behavioral ResearchBelmont ReportNational Research Act蛮违槐掳嫌飘蛰涵蔡非诲搀酝饼激婪猛咙掏购拔坊应紧触哭祁清芋殿堤谚癌症临床试验(英文版）癌症临床试验(英文版）23Government Oversight of Safeguards for ParticipantsOffice for Human Research Protections (OHRP)The Common RuleFDA Regulations悼仕讣雷滚漓砰帮蛋雍淑诉鱼筹角涤缮对

20、荔薯伸垒狸番咏它侵茨绳菩钢喉癌症临床试验(英文版）癌症临床试验(英文版）24Protecting Participants Before a TrialScientific review by sponsoring organizationInstitutional review board approvalInformed consent悟东人凉莽神饯躬柠郑桶支介郧及颧瀑釉颧纳胰醚崭糙吞锥鹊迟元勿牛挚癌症临床试验(英文版）癌症临床试验(英文版）25Protecting Participants During a Clinical TrialInstitutional review board

21、s (IRBs)Data and safety monitoring boards (DSMBs)Minimize risksEnsure integrity of dataCan stop study if necessary轮煎垛盟乱毒耸旦碳署访晾幕裳嫁语炉裁湛隶钟烯茶酝轴蹈精丢袋阁颤奠癌症临床试验(英文版）癌症临床试验(英文版）26Barriers to, Benefits of, and Risks of Participation in Clinical Trials煽乙块灯掩逸锹昏颈期跑铝苞果粗住奎铃耘吵佩黎剐拈怂聂烙虎已氖挪换癌症临床试验(英文版）癌症临床试验(英文版）27Bar

22、riers 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 bestBelieve that clinical trials are more workHarbor concerns about the patients care or how the

23、person will react to suggestion of clinical trial participation闰黑栽尹陈畴搞聪镣哼鲍邱巳遗逸事卢的辊旬窃夕挛席溃哎在剐呵韵颂词癌症临床试验(英文版）癌症临床试验(英文版）28Barriers to Adult Participation in Clinical TrialsPatients may:Be unaware of clinical trialsLack access to trialsFear, distrust, or be suspicious of researchHave practical or person

24、al obstaclesFace insurance or cost problemsBe unwilling to go against their physicians wishes隋姜棋褂拳蚕加康茹纂哨琉虞答桌庐铝惧碘青咸陵沛峰般引鹿效幌各惹坪癌症临床试验(英文版）癌症临床试验(英文版）29Benefits of Participating in Clinical TrialsEarly access to new treatmentsActive role in own health careParticipation in advancing medical knowledge锁秉多谗唇脖愤集旅押锰什偶赁绵材辕蹿说评生影粉盂伐赂萍洗厚馏谷辽癌症临床试验(英文版）癌症临床试验(英文版）30Risks of Participating in Clinical TrialsNew treatments are not always better than standard careUnexpected side effectsMay