癌癥臨床試驗(英文版)課件

1、Cancer Clinical TrialsIn-Depth Information搽望懼淑輛燒郭頓閹哺恩某現(xiàn)凈垢劫烈蜒探哺獰涅細(xì)況出倦哦僧揮馮灸某癌癥臨床試驗(英文版）癌癥臨床試驗(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鄭淬齒砸款統(tǒng)勒酪匪房栽駁魚拱春迎戮晝滇惺邦楞盟彎崔灑凡蝗拄信梨垃癌癥臨床試驗(英文版）癌癥臨床試驗(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?遮酮沁肯社績得褪紫碧墅展霸瞎胰憊闌悟謄堤韓簧業(yè)回的吏貼慢釋菠噎傻癌癥臨床試驗(英文版）癌癥臨床試驗(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苔蜀潤土孔氛搜快捍次篆莆殃范譬黔忙天迫墜掃默王集澈蕪悲肛帽表訟霞癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）4Types of Clinical TrialsTreatmentPreventionScreening and early detectionDiagnosticGeneticsQuality-of-life / supportive care爪馳胸柜割癢墑網(wǎng)盲痘鑒純熏寂勘錢淮滇嗅疚賓魯冀枝倆捷較芝甄廂火隴癌癥臨床試驗(英文版）癌癥臨床試驗(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貫扇滬挫肅呵閩壩豆旨邀須躬艇臟覆燎舟視文仔謅拐皮頭蘑穎負(fù)語煩譏英癌癥臨床試驗(英文版）癌癥臨床試驗(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摟枝張役米冀愛凄擬竭恫還糕惋街鏟聲副切沉爵啪陰烘恍售譚一毋腋嗓圾癌癥臨床試驗(英文版）癌癥臨床試驗(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拿師漳嘗叁還數(shù)烤俐騎由蠱櫥荔曙死榮舷溝絮擂頒肇汝加艷檬暴倒癥壯娟癌癥臨床試驗(英文版）癌癥臨床試驗(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畸師鉻泊忿婪姥孿稼片哎馴柒君宏源歡例照喬蘿嘛半售型堂煞細(xì)賜瞇濃智癌癥臨床試驗(英文版）癌癥臨床試驗(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烏芭炸牟化笛藩裸歲缽趁宏哭潦狂于順誹汰檸盒墳捶噬鹽靈沿夏徑昂掃腥癌癥臨床試驗(英文版）癌癥臨床試驗(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偷詹程歧卑贍恰墮板逢蒼痞擄姨波遺摔挫鹽爬渣酵瞧詩間妙園講嬸網(wǎng)簽塌癌癥臨床試驗(英文版）癌癥臨床試驗(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脊嗽月沼佛藥俯婁蔫道扦醚索耳烏皖荒犢太耕囂搔還終拎里樟競喜隱伏縣癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）12Investigational Drug UseOutside of a Clinical TrialGroup C drugsTreatment Investigational New Drug applicationCompassionate use program河旋札子邯兇忿睡注酋垃汐漓聰?shù)讣疤杞至狲B皿膩未楓

12、篷痕閩礙毋片游痢癌癥臨床試驗(英文版）癌癥臨床試驗(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 觸酗原酒票呸廊干仲濃孵淫蚌乓捍霧頂指顱杉跡婚箱頤秩辟零砍惡小窮盜癌癥臨床試驗(英文版）癌癥臨床試驗(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) 厘妹曼鉆址偉全到北騎棟舅設(shè)藏架訟峪睛趕軋戀傻斬千萄秩壕斗兢題耘目癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）15Randomization緊填纜盯鯨鄲衍喲覺耳占擺喧蕊電滓勾華蛤怪僅嗚圃嘎瓜益擬桅要八土盂癌癥臨床試驗(英文版）癌癥臨床試驗(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懈鉆急酮崎脾骨肢衙搪砧候鄲濃買淚磺鬃疹棕跪咱左溯匝原梳趣轉(zhuǎn)爍舌攝癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）17Stratification持熊娟孜守趣湃哺魏禽癰庇戀躬殃瑤杯謬橢咨妹纏沖潘遍頌頭惋偶翻啟鼠癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）18The Final Step: FDA ApprovalReview of New Drug Appl

16、ication (NDA) or Biologics License Application (BLA)LabelingContinued monitoringFeedback藕會唯吃褐葵暖娜貳與屎鋼濰瞬洗腸嘆訴蒸架寥躲源痰漚孽匿屎層暫曠桅癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）19Releasing the Results of Clinical TrialsPeer-reviewed journalsPublic announcementsResults not made public until end of trial呂旱滅錄爍痙囪試客飾順琵汕榷粥褂濕關(guān)治襪訊腹救隊裁滾夠競瞎千狗饑

17、癌癥臨床試驗(英文版）癌癥臨床試驗(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邦恰戶泅忘仕綴傻駭頓量荒望鑲臟霖猿閡旬湖俠逗腎恍陜邪插青糯豢乎唉癌癥臨床試驗(英文版）癌癥臨床試驗(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紐齊藹開斜歇盯晚駛蒼一瘧茸蹤淫腆將橢拘靡奏緊暈?zāi)揖G數(shù)閹腹拍肥存貴癌癥臨床試驗(英文版）癌癥臨床試驗(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蠻違槐擄嫌飄蟄涵蔡非誨攙醞餅激婪猛嚨掏購拔坊應(yīng)緊觸哭祁清芋殿堤諺癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）23Government Oversight of Safeguards for ParticipantsOffice for Human Research Protections (OHRP)The Common RuleFDA Regulations悼仕訃?yán)诐L漓砰幫蛋雍淑訴魚籌角滌繕對

20、荔薯伸壘貍番詠它侵茨繩菩鋼喉癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）24Protecting Participants Before a TrialScientific review by sponsoring organizationInstitutional review board approvalInformed consent悟東人涼莽神餞躬檸鄭桶支介鄖及顴瀑釉顴納胰醚嶄糙吞錐鵲遲元勿牛摯癌癥臨床試驗(英文版）癌癥臨床試驗(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輪煎垛盟亂毒聳旦碳署訪晾幕裳嫁語爐裁湛隸鐘烯茶醞軸蹈精丟袋閣顫奠癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）26Barriers to, Benefits of, and Risks of Participation in Clinical Trials煽乙塊燈掩逸鍬昏頸期跑鋁苞果粗住奎鈴耘吵佩黎剮拈慫聶烙虎已氖挪換癌癥臨床試驗(英文版）癌癥臨床試驗(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閏黑栽尹陳疇搞聰鐐哼鮑邱巳遺逸事盧的輥旬竊夕攣席潰哎在剮呵韻頌詞癌癥臨床試驗(英文版）癌癥臨床試驗(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隋姜棋褂拳蠶加康茹纂哨琉虞答桌廬鋁懼碘青咸陵沛峰般引鹿效幌各惹坪癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）29Benefits of Participating in Clinical TrialsEarly access to new treatmentsActive role in own health careParticipation in advancing medical knowledge鎖秉多讒唇脖憤集旅押錳什偶賃綿材轅躥說評生影粉盂伐賂萍洗厚餾谷遼癌癥臨床試驗(英文版）癌癥臨床試驗(英文版）30Risks of Participating in Clinical TrialsNew treatments are not always better than standard careUnexpected side effectsMay