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详细信息
全球各国临床试验API数据接口
临床试验是一段跨越两千多年、融合了科学进步、伦理觉醒与制度规范的波澜壮阔的历程，见证了医学从经验探索到科学验证的转变，但因地缘发展原因，使得美国、欧盟、日本、英国、中国的临床试验数据内容并不完全相同，而如何将各国的这些临床试验数据融合成一个全球临床试验数据集则是今天所要谈论的议题。
其实，建立并融合这样一个庞大的数据非常简单，并不需要我们一点一滴的去采集规整各国的临床试验数据，只需要找到各个国家的临床试验数据API接口，然后建立统一字段即可实现，而各国临床试验数据库接口可以直接通过摩熵数科开放平台获取，其数据结构内容如下:
图源：摩熵数科开放平台
美国临床试验API接口
{
"试验登记号": "NCT02332850",
"登记日期": "2015-01-07",
"其他试验登记号": ["NCI-2015-00712", "139511"],
"试验标题":"Phase Ib Study of SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma",
"正式的科学名称": "A Multi-ARM Phase Ib Study of SAR650984 (Isatuximab, an Anti-CD38 mAb) in Combination With Standard Carfilzomib, and High-dose Weekly Carfilzomib and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma",
"国家/地区": ["United States(美国)","Canada(加拿大)"],
"开始日期": "2015-01-21",
"首例受试者入组日期": "2015-01-07",
"主要终点完成日期": "2021-10-14",
"结束日期": "",
"结果发布日期": "2025-01-01",
"最近更新日期": "2025-05-01",
"招募状态":"Active, not recruiting（试验进行中，但目前不招募）",
"注册机构": "美国",
"申办单位": ["University of California San Francisco（美国加州大学旧金山分校）"],
"合作方": ["Amgen Inc（安进）","Sanofi Inc（赛诺菲）"],
"药品名称":["Variable regimens including carfilzomib","dexamethasone", "isatuximab(艾沙妥昔单抗)" , "isatuximab + carfilzomib + dexamethasone"],
"干预信息": [{"名称":"isatuximab","干预类型":"生物药"},{"名称":"dexamethasone","干预类型":"药品"}，{"名称":"carfilzomib","干预类型":"药品"}],
"靶点": [{"全称":"CD38 Molecule（CD38）","简称":"CD38","中文":"环腺苷二磷酸核糖1","别名":["CD38 Antigen","ADPRC1","T10"],"详情":"https://www.uniprot.org/uniprotkb/P28907"}],
"作用机制": ["ADP ribosyl cyclase-1 inhibitor（环腺苷二磷酸核糖1抑制剂）","Proteasome inhibitor（蛋白酶体抑制剂）","Ubiquitin inhibitor（泛素化抑制剂）"],
"适应症": ["multiple myeloma（多发性骨髓瘤）"],
"工艺技术": ["Biological（生物药）","Formulation powder（粉末制剂）","Freeze drying（冻干制剂）","Solution（溶液剂）","Subcutaneous formulation（皮下注射剂）"]，
"治疗领域": ["癌症及其他肿瘤","心血管系统疾病","血液和淋巴系统疾病","免疫性疾病"],
"试验阶段": ["Phase 1 Clinical（Ⅰ期）"],
"试验类型": ["Interventional（干预性研究）"],
"试验目标":["Treatment（治疗性）"],
"干预类型": ["Biological（生物药）","Drug（药品）"],
"干预分组方式": "随机化",
"干预模型": "平行设计",
"盲法": "单盲",
"设盲对象": "结果评价人员",
"观察模型": "",
"观察时间点": "",
"患者登记研究": "",
"患者登记随访持续时间": "",
"生物标本存放形式": ""，
"生物标本说明": ""，
"生物标记物作用": "Male and Female",
"性别": "Male and Female"，
"性别": "Male and Female",
"终点类型":["Safety（安全性）","Efficacy（有效性）","Pharmacokinetics（药代动力学）","Pharmacodynamics（药效学）"] ,
"主要终点指标": [{"指标":"Incidence of Dose-Limiting Toxicities (DLT)","评价时间":"Up to 60 days of the last dose of study drug","描述":"Treatment-related Adverse events resulting in a DLT will be summarized by maximum toxicity grade for each dose level of isatuximab."}],
"次要终点指标": [{"指标":"Incidence of isatuximab-specific antidrug antibodies (ADA) ","评价时间":"Up to 1 year ","描述":"Analysis of Incidence of isatuximab-specific antidrug antibodies (ADA) to be performed by Sanofi-Oncology."}],（样例数据）
"其他终点指标": [{"指标":" Overall survival (OS)","评价时间":"assessed at 1, 2, and 3 years from start of treatment","描述":" Duration of time from start of treatment to death on study from any cause,"}],（样例数据）
"目标入组人数": "80",
"实际入组人数": "83"，
"年龄范围": "18 Years - No limit",
"性别": "Male and Female"，
"是否接受健康受试者": "No",
"入组期限": "110.39 Months"，
"入组率": "0.75 Patients/Month",
"联系人信息": [{"联系人类别":"试验联系人","姓名":"Clinical Trials Referral Office","联系方式":"mayrstudies@mmmn.edu"}], （样例数据）
"试验点信息": ["Princess Margaret Cancer Centre","Icahn School of Medicine at Mount Sinai","Colorado Blood Cancer Institute","University of California, San Francisco","Sarah Cannon Cancer Center","Hackensack University Medical Center"]，
"临床试验结果": [{"结果名称":"Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients","结果链接":"https://clinicaltrials.gov/study/NCT03275285?rank=3&tab=results"}],（样例数据）
"试验文件": [{"文件名称":"Study Protocol","文件链接":"https://cdn.clinicaltrials.gov/large-docs/85/NCT03275285/Prot_002.pdf"}],（样例数据）
}
中国临床试验API接口
{
"药品名称": "RX208(HLX208)片",
"规范名称": "RX-208片",
"药物类型": "化学药物",
"适应症": "成人朗格汉斯细胞组织细胞增生症（LCH）和Erdheim-Chester病（ECD）",
"靶点": ["B-Raf Proto-Oncogene","Serine/Threonine Kinase（BRAF）"],
"方案是否为联合用药": "否",
"申请人名称": ["苏州润新生物科技有限公司"],
"试验专业题目": "一项评估HLX208片在BRAF V600E突变的成人朗格汉斯细胞组织细胞增生症（LCH）和Erdheim-Chester病（ECD）中的有效性、安全性和PK的罕见病单臂、开放、多中心的Ⅱ期临床研究",
"试验通俗题目": "一项评估HLX208片在BRAF V600E突变的成人朗格汉斯细胞组织细胞增生症（LCH）和Erdheim-Chester病（ECD）中的有效性、安全性和PK的罕见病单臂、开放、多中心的Ⅱ期临床研究",
"首次公示信息日期": "2021-10-14",
"试验状态": "进行中",
"临床受理号": ["企业选择不公示"],
"版本日期": "2023-06-16",
"试验目的": "主要目的：(1) 评估HLX208片对携带BRAF V600E突变的成人朗格汉斯细胞组织细胞增生症（Langerhans cell histiocytosis，LCH）和Erdheim-Chester病（Erdheim-Chester Disease，ECD）受试者的客观缓解率（Objective Response Rate, ORR）次要目的：(1) 评估HLX208片在成人LCH/ECD受试者群体中的安全性和耐受性(2) 进一步评估HLX208片对BRAF V600E突变的成人LCH/ECD受试者的除基于PERCIST v1.0标准评估的ORR之外的其他有效性(3) 进一步评价HLX208片及其代谢物（如适用）的PK特征探索性目的：(1) 受试者血浆游离DNA（circulating cell-free DNA，cfDNA）中BRAF V600E突变的表达量、检出率以及与疗效的关系。",
"试验分类": "安全性和有效性",
"试验分期": "II期",
"设计类型": "单臂试验",
"随机化": "非随机化",
"盲法": "开放",
"试验状态（招募状态）": "招募完成",
"登记号": "CTR20212459"
}
欧盟临床试验ctrAPI接口
{
"试验登记号":"2015-003958-41",
"官网链接":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/NL",
"登记日期":"",
"其他试验登记号":["NSR-REP-01","Biogen-protocol-273CH301","NCT03496012"],
"试验标题":"Trial of a Gene Therapy for the Treatment of Chorioderemia",
"正式科学名称":"A Single-Masked, Randomised, Controlled, Parallel Group, Phase 3 Clinical Trial Of Retinal Gene Therapy For Choroideremia Using An Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)",
"试验简称":"STAR Study",
"国家主管机构":"丹麦",
"国家/地区":["Brazil（巴西）","Canada（加拿大）","United States（美国）","United Kingdom（英国）","France（法国）","Denmark（丹麦）","Finland（芬兰）","Germany（德国）","Netherlands（荷兰）"],
"开始日期":"2016-10-31",
"结束日期":"2020-12-01",
"最近更新日期":"2016-04-11",
"试验状态":"Completed（试验结束）",
"招募状态":"",
"注册机构":"欧盟",
"干预类型":["Biological（生物药）","Gene therapy（基因疗法）"],
"药品信息":[{"药品名称":"","活性成分":"timrepigene emparvovec","药物剂型":"Suspension for injection","给药途径":"Intraocular use","药物类型":"","商品名":"","持证商":""}],
"适应症":["choroideremia（脉络膜缺损）"],
"治疗领域":["眼疾病"],
"试验阶段":"Phase 3 Clinical（Ⅲ期）",
"试验目标":["Treatment（治疗性）"],
"干预分组方式":"随机化",
"盲法":"开放标签",
"对照类型":"其他",
"设计类型":"平行设计,其他",
"组数":"3",
"终点类型":["Safety（安全性）","Efficacy（有效性）"],
"主要疗效":[{"判定指标1":"Change from baseline in best corrected visual acuity (BCVA).",
"时间节点1":"BCVA assessments will be performed as per protocol."}],
"次要疗效":[{"判定指标1":"Visual assessments will be performed as per protocol.","时间节点1":"Safety assessments will be performed at all timepoints."}],
"目标入组人数":"100",
"年龄范围":"18-64 years",
"受试者性别":"Male",
"受试者范围":"Patients",
"入选标准":[
"Subjects are eligible for study participation if they meet all of the following inclusion criteria.",
"1. Are willing and able to provide informed consent for participation in the study.",
"2. Are male and ≥18 years of age.",
"3. Have a genetically-confirmed diagnosis of CHM.",
"4. Have active disease clinically visible within the macular region in the study eye.",
"5. Have reduced visual acuity in the study eye"],
"排除标准":[
"Subjects are not eligible for study participation if they meet any of the following exclusion criteria.",
"- Any significant disease/disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study.",
"- Have participated in another research study involving an investigational product in the past 12 weeks or received a gene/cell-based therapy at any time previously."],
"申办单位":["NightstaRx Ltd"],
"合作单位":[""],
"联系人信息":[{"联系人类别":"试验联系人","姓名":"NightstaRx Ltd,Clinical Operations Department", "联系方式":"4402076112077"}],
"是否有临床试验结果":"是",
"临床试验结果":[{
"text":"A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial of Retinal Gene Therapy for Choroideremia Using an Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1) [STAR]",
"url":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/results"}],
"试验文件":[{"text":"德国,试验结束","url":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/DE"}
{"text":"芬兰,试验结束","url":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/FI"}
{"text":"丹麦,试验结束","url":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/DK"}],
}
日本临床试验API接口
{
"试验登记号":"UMIN000054277",
"查看全文":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061771",
"登记日期":"2024-04-28",
"其他试验登记号":["1637/E/MDX","C12-17"],
"试验标题":"TEFFICACY AND SAFETY OF TESOFENSINE FOR THE TREATMENT OF OBESITY IN ADULTS. A PHASE 3 RANDOMIZED CONTROLLED STUDY",
"正式的科学名称":"Clinical study to evaluate the efficacy and safety of Tesofensine on body weight loss and body composition of Mexican patients with obesity. Double-blind, randomized, placebo-controlled, multicenter clinical trial.",
"试验简称":"MEX-TESObesity;TESObesity",
"国家/地区":["North America（北美）"],
"开始日期":"2017-08-08",
"结束日期":"",
"末次随访日期":"2018-01-29",
"最近更新日期":"2024-04-27",
"招募状态":"Completed（完成招募）",
"注册机构":"日本",
"药品名称":[""],
"适应症":["Obesity（肥胖）"],
"治疗领域":[""],
"试验阶段":"Phase 3 Clinical（Ⅲ期）",
"试验类型":["Interventional（干预性研究）"],
"试验目标":["Treatment（治疗性）"],
"干预类型":["Drug（药品）"],
"干预分组方式":"随机化",
"盲法":"双盲",
"对照类型":"安慰剂对照",
"设计类型":"平行设计",
"组数":"3",
"试验方案":[{"干预组别":"Interventions/Control_1","干预措施":["Intervention - Tesofensine 0.25 mg"]},{"干预组别":"Interventions/Control_2","干预措施":["Intervention - Tesofensine 0.50 mg"]},{"干预组别":"Interventions/Control_3","干预措施":["Placebo"]}],
"终点类型":"Other（其他）",
"主要的疗效判定指标":["1. Mean change in absolute and percentage body weight after 24 weeks of treatment 2. Proportion of drug-related adverse events after 24 weeks of treatment"],
"次要的疗效判定指标":["1. Proportion of subjects who reached a body weight percentage equal or higher than 5 and 10 percentage after 12 and 24 weeks of treatment. 2. Absolute difference between baseline and week 24 in body mass index "],
"目标入组人数":"372",
"实际入组人数":"372",
"年龄范围":"18 years - 65 years",
"性别":"Male and Female",
"入选标准":["1. Men and women with ages between 18 to 65 years,",
"2. A body mass index (BMI) greater than or equal to 30 and lower than 50,",
"3. Agreed to participate in the study and provided their written informed consent.",
"4. Women of childbearing age who declared using a contraceptive method"],
"排除标准":["1. Pregnant or lactating women",
"2. Hypersensitivity to tesofensine",
"3. Treatment with special diets (vegan or ketogenic)",
"4. Prior pharmacological or surgical treatment against obesity,",
"5. Presence of chronic metabolic diseases or another diseases as:",
"a) Uncontrolled type 2 diabetes (without regular treatment with metformin or lifestyle modifications)",
"b) Uncontrolled systemic arterial hypertension",
"c) Psychiatric illnesses",
"d) Thyroid disease",
"e) Cardiovascular diseases",
"f) Gastrointestinal malabsorptive disease",
"g) Cancer",
"h) Ophthalmologic disease",
"i) Electrocardiographic abnormalities",
"j) History of hypotension"],
"首例受试者入组日期":"",
"申办单位":["Instituto Politecnico Nacional"],
"合作单位":[""],
"联系人信息":[{"联系人类型":"公众联系人","姓名":"Reyes-Garcia Gerardo Juan","联系方式":"525557296300;jgreyesg@ipn.mx"},{"联系人类型":"科学联系人","姓名":"Reyes-Garcia Gerardo Juan","联系方式":"525557296300;jgreyesg@ipn.mx"}"],
"是否有临床试验结果":"是",
"临床试验结果":[{"结果名称":"","结果链接":" https://siipris03.cofepris.gob.mx/Resoluciones/Consultas/ConWebRegEnsayosClinicosDetalle.asp?idsolic"],
}
英国临床试验API接口
{
"试验登记号":"ISRCTN73887615",
"英国官网链接":"https://www.isrctn.com/ISRCTN73887615",
"登记日期":"2018-10-10",
"其他试验登记号":["RG_17-229","IRAS248487"],
"试验标题":"Carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis",
"正式的科学名称":"CArvediloL versus varIceal Band ligation in primary pREvention of variceal bleeding in liver cirrhosis",
"试验简称":"CALIBRE",
"国家/地区":[
"England（英格兰）Northern Ireland",
"Scotland, United Kingdom（英国）",
"Wales"],
"开始日期":"2018-03-01",
"结束日期":"2024-05-31",
"最近更新日期":"2025-04-28",
"招募状态":"No longer recruiting（不再招募）",
"注册机构":"英国",
"药品名称":"Carvedilol",
"干预信息":[{"名称":"Carvedilol","干预类型":"Drug"}],
"适应症":["variceal bleeding in liver cirrhosis"],
"治疗领域":["消化系统疾病"],
"试验阶段":"Phase 3 Clinical（Ⅲ期）",
"试验类型":["Interventional（干预性研究）"],
"试验目标":["Treatment（治疗性）"],
"干预类型":["Drug（药品）"],
"终点类型":["Efficacy（有效性）"],
"试验设计":["Interventional prospective multicentre pragmatic open-label two-arm randomized controlled parallel group trial with internal pilot"],
"试验方案":[
"After participant eligibility has been confirmed and informed consent has been received, the participant can be randomised into the trial. A Randomisation Form will be ……stored in a confidential document at BCTU.",
"Participants will be in the study for a total duration of 12 months from the point of randomisation."
],
"主要的疗效判定指标":["Any variceal bleeding within 12 months of randomisation, assessed through endoscopy for the variceal band ligation (VBL) and through observation for the carvedilol arm at 4 weeks and after 6 and 12 months"],
"次要的疗效判定指标":[
"1. Time to first variceal bleed in days from randomisation, assessed through endoscopy for the variceal band ligation (VBL) and through observation for the carvedilol arm at 4 weeks and after 6 and 12 months.",
"2. Mortality at 12 months from randomisation,assessed using medical records and staff notification after 6 and 12 months:",
"2.1. All-cause mortality.",
"2.2. Liver-related mortality"],
"目标入组人数":"2630",
"实际入组人数":"266",
"受试者人群":"Patient",
"年龄范围":"20 years - No limit",
"性别":"Both",
"入选标准":[
"1. Liver cirrhosis as defined clinically, radiologically (USS and transient elastography), or on histology.",
"2. Medium varices (Grade II varices that do not flatten on air insufflation and do not occlude the lumen) and large varices (Grade III varices which are larger than Grade II varices and occupy the whole lumen) that have never bled as defined in the BSG guidelines.",
"3. Aged 18 years or older."],
"排除标准":[
"Current exclusion criteria as of 24/11/2021:",
"1. Age <18 years.",
"2. Pregnant or lactating women.",
"3. Known intolerance or contraindications to beta-blockers including asthma."],
"申办单位":["University of Birmingham"],
"合作单位":["Health Technology Assessment Programme"],
"联系人信息":[{"联系人类别":"试验联系人","姓名":"Dr Lisa Holden","联系方式":"+44 (0)121 414 7943;l.m.holden@bham.ac.uk"}],
"是否有临床试验结果":"是",
"临床试验结果":[{"文献内容":"Protocol article","文献链接":"https://doi.org/10.1136/bmjgast-2019-000290/"},{"文献内容":"Results article","文献链接":"https://pubmed.ncbi.nlm.nih.gov/40241373/"],
"试验停止原因":"",
"试验文件":[{"文献内容":"HRA research summary","文献链接":"https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/calibre-2/."},{"文献内容":"Protocol file","文献链接":"https://www.isrctn.com/editorial/retrieveFile/750160ec-59b8-4c9a-90bc-c042ae324417/35827"],
}
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