使用体外诊断试剂境外临床试验数据的技术指南(征求意见稿)

2020-11-26 器审中心 器审中心

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今日,中国器审中心发布《使用体外诊断试剂境外临床试验数据的技术指南(征求意见稿)》,全文如下:全球化和一体化是当今世界的发展趋势,在此背景下,如何避免或减少医疗器械申请环节的重复性临床试验,加快医疗器械在我国的上市进程更好地满足公众对医疗器械的临床需要促进医疗器械的技术创新,是各国监管机构共同面临的挑战。为此,国家药品监督管理局发布了《接受医疗器械境外临床试验数据的技术指导原则》,以便为申请人和技术审评人员提供及时科学的技术指导。

体外诊断试剂作为一类特殊的医疗器械,随着产品创新的加速,临床证据在产品上市过程中发挥着越来越重要的作用。在使用境外临床试验数据作为我国注册申报的临床证据时,需要对其合理性和充分性等进行分析,以判定境外临床试验数据是否可作为临床证据用于我国注册申报,以及是否需要提供进一步的境内外临床试验数据。

本操作指南旨在明确使用体外诊断试剂境外临床试验数据作为我国注册申报临床证据时应考虑的几问题,明确使用境外临床试验数据在我国注册申报体外诊断试剂时的认可准则与标准,明确境内外监管要求差异情况进行分析的操作路径,并举例说明差异情况,以便为申请人使用境外临床试验数据进行注册申报提供技术指导同时为监管机构对该类临床试验数据的技术审评提供指导。

一、 范围

本操作指南旨在为申请人使用境外临床试验数据作为体外诊断试剂在我国注册申报临床证据提供指导,适用于进行首次注册申报和相关许可事项变更申请产品。

操作指南声称的境外临床试验数据是指,全部或同期在境外具备临床试验开展所在国家(地区)要求条件的临床试验机构中,对拟在我国申报注册的体外诊断试剂进行临床试验时所产生的研究数据。

二、 境内外临床试验差异的重点考虑

使用境外临床试验数据作为我国注册申报的临床证据时,首先应对境内外临床试验进行差异分析,以确定境外临床试验数据作为我国注册申报临床证据的充分程度。境内外临床试验差异应重点考虑境内外临床试验质量管理要求的差异(包括伦理要求)以及境内外临床试验设计关键要素的差异等。

(一)境内外临床试验质量管理要求的差异

申请人应重点关注如下内容:

1、境外临床试验所在国家(地区)监管机构是否对临床试验有完整的质量管理要求;

2、进行临床试验时,境外临床试验机构是否按要求进行了严格的临床试验质量管理;

3、境外临床试验所在国家(地区)与我国体外诊断试剂临床试验质量管理是否存在差异;如存在,是否导致境内外临床试验数据的差异。

(二)境内外临床试验设计关键要素的差异

临床试验设计显著影响临床试验结果。临床试验设计的关键要素主要包括:临床试验机构和人员(临床试验条件)、对比方法/试剂、样本量、受试人群及样本及统计分析等。基于现有认知,本技术指南对可能的差异进行了梳理,但并未穷举所有差异。为便于理解,本技术指南还结合典型例子进行了举例说明。针对具体产品,申请人应根据产品特点进行分析确认。

1、临床试验机构和人员(临床试验条件)的差异

1.1 临床试验机构的差异

临床试验机构的差异应关注机构数量、资质或条件等的差异。例如,我国要求二类或三类体外诊断试剂分别在至少2家或3家临床试验机构进行临床试验。申请人应关注申报产品在我国的管理类别,以确定进行境外临床试验的机构数量是否满足我国相关要求,如不满足,应在境外或境内补充临床试验。如某些产品对临床试验机构的条件或资质有特殊要求,申请人还应考虑特殊要求可能导致的境内外临床试验数据的差异。

1.2 临床试验人员的差异

对于可供非专业人员使用的自测类产品及结果的判读受临床试验人员主观影响较大的组化类产品等,境内外临床试验人员的差异可能显著影响其对临床试验用产品的使用及结果的判读等,从而导致境内外临床试验数据的差异。

例1:预期使用人群为专业人员和糖尿病患者等非专业使用者的自测用血糖试纸。临床试验需要评价非专业使用者对产品的使用能力、对产品说明书的认知能力,以及非专业使用者与专业人员检测结果的一致性。境内外非专业使用者在受教育程度、依从性、对说明书的认知能力以及操作使用能力等方面可能存在差异,导致境外临床试验的适用人群不能代表境内预期使用人群,从而导致境内外临床试验数据的差异。申请人应在我国境内补充临床试验,以确认申报产品适用于我国非专业使用者。

例2:用于检测福尔马林固定、石蜡包埋人乳腺癌组织切片中HER-2蛋白的HER-2抗体试剂,其结果判读较为复杂,受病理阅片者的主观影响较大。该类试剂一般采用0、1+、2+和3+进行半定量分级判读,境内外病理阅片者对0、1+、2+和3+的判断可能存在较大差异,从而导致境内外临床试验数据的差异。申请人应在我国境内补充临床试验,以确认申报产品适用于我国临床使用场景。

例3:用于筛选特定免疫治疗人群的PD-L1抗体伴随诊断试剂,其染色步骤和结果判读较为复杂,受临床试验操作人员和病理阅片者的主观影响较大。境内外临床试验人员的差异可能导致境内外临床检测性能不同。申请人应在我国境内补充临床试验,以确认申报产品适用于我国临床使用场景。

2、对比方法/试剂的差异

境内外临床试验一般采用临床参考标准(如:临床诊断、培养鉴定、表型药敏等)或已上市同类产品作为对比方法/试剂。

2.1如境外临床试验采用临床参考标准作为对比方法,申请人应关注境内外临床参考标准(如:实际操作和结果判读等)的差异。

例4:微生物药敏试剂的临床试验一般采用微量肉汤稀释法作为临床参考标准。境外临床试验时,该方法的耐药折点通常采用进行临床试验时有效的CLSI、FDA或EUCAST(欧洲抗菌药物敏感性试验委员会)耐药折点,我国主要采用CLSI折点或中国人群的折点,并且这些折点会不定期更新,上述情况可能造成境外临床试验临床参考标准所采用的折点与申报产品在我国注册申报时现行使用的折点不同,导致境内外临床参考标准试验结果的差异。

2.2 如境外临床试验采用同类产品作为对比试剂,申请人应关注所用对比试剂在我国的上市情况,申请人应采用中国已上市的同类产品作为对比试剂。

3、样本量的差异

我国在体外诊断试剂通用指导原则里明确了样本量确定的一般考虑,并在某些产品的指导原则里规定了该类试剂样本量的具体要求,如对基因型或突变位点等特定亚组的阳性例数要求。针对具体产品的样本量,境内外监管机构可能具有不同要求。申请人应关注境外临床试验的样本量是否满足我国通用指导原则及具体产品指导原则等的相关要求,如不满足,应视情况在境外或境内补充临床试验。

4、受试人群的差异

尽管境外临床试验数据支持申报产品在所在国家(地区)人群的使用,部分产品由于境内外受试人群的人种(种族)、遗传信息、疾病特征、体质、体内生理生化特征、境内外预期用途及受试人群中病原体流行情况等的差异,造成境外受试人群不能代表境内受试人群的全部特征,可能导致境外临床试验数据无法充分支持申报产品在中国人群的使用。境内外受试人群的差异包括但不限于:

4.1、不同人种(种族)遗传信息的差异

可能涉及该类差异的产品主要为用于人类基因检测的产品,如:药物作用靶点基因多态性检测试剂、药物代谢酶基因多态性检测试剂及伴随诊断试剂等。

例6:药物作用靶点基因多态性检测试剂。同一多态性位点对于境内外人群可能具有不同的临床意义,导致境外进行的基因多态性与药物使用相关性的临床证据无法直接外推至中国人群。例如,用于华法林用药剂量指导的VKORC1基因多态性检测试剂。维生素k环氧化物还原酶复合体亚单位1(VKORC1)是华法林的作用靶点。华法林通过抑制VKORC1的活性,发挥抗凝作用。不同个体华法林的用药剂量差异较大,这种差异受多种因素影响,其中VKORC1基因启动子区的单核苷酸多态性rs9923231(-1639 G>A)是主要因素之一。研究表明,与携带GA和GG基因型的患者相比,携带AA基因型患者的华法林平均使用剂量显著降低。由于该位点的多态性分布具有明显的种族差异,AA、GA和GG基因型在中国人群中的发生频率分别为79.7%、17.6%和2.7%,而在白种人群中的发生频率分别为14%、47%和39%,因此,该位点多态性用于华法林用药剂量指导的权重在境内外不同种族人群间存在显著差异。境外基于其他种族人群的临床试验数据建立的包含该基因多态位点的华法林药物基因组学剂量预测模型不能直接外推至中国人群。申请人应提供相关临床证据,以明确基于中国人群的包含该基因多态位点的华法林药物基因组学剂量预测模型。当有类似情况的药物作用靶点基因多态性检测试剂新产品申报时,申请人应关注境内外基因多态性与药物使用相关性是否具有差异。

例7:药物代谢酶基因多态性检测试剂。对于同一多态性位点,境内外人群的发生频率可能存在差异,导致境外临床试验数据无法满足我国临床试验阳性例数的要求。例如,用于硝酸甘油用药指导的ALDH2基因多态性检测试剂。线粒体乙醛脱氢酶2(ALDH2)将硝酸甘油代谢为活性产物一氧化氮。携带突变等位基因(ALDH2*2,G1510A)的个体,其ALDH2酶活性下降,杂合子个体酶活性仅为野生型个体的10%,突变纯合子个体酶活性缺失。因此,携带ALDH2*2等位基因的心绞痛患者对硝酸甘油的代谢能力下降,应尽可能改用其他急救药物,避免硝酸甘油含服无效。中国人群中ALDH2*2等位基因的携带率为30~50%,白种人和黑人几乎不携带,导致境外临床试验数据可能不含有ALDH2*2等位基因阳性病例。申请人应在我国境内补充该等位基因的阳性病例,以满足我国临床试验中有关阳性病例数的要求。

4.2、疾病特征的差异

境内外疾病患病率、病原体流行率或感染率、疾病分型、疾病病因、体质和体内生理生化状态等的差异,可能造成境内外临床试验数据的差异。

例8:疾病患病率和病原体感染率等的差异。用于疾病筛查的试剂受此因素影响较大,如用于高级别宫颈病变筛查的人乳头瘤病毒(Human Papilloma Virus,HPV)核酸检测试剂。该类试剂用于高级别宫颈病变的风险预测,鉴别具有高级别宫颈病变风险的人群,临床评价指标受适用人群中宫颈癌患病率、各亚型HPV感染率及其导致宫颈癌病变的风险程度等多种因素的显著影响。现有研究表明,境内外人群营养和卫生条件等的差异可能导致宫颈癌的总体患病率和不同年龄段等亚组人群的患病率明显不同;另外,境内外疫苗接种等的差异可能导致不同病变程度等亚组人群中HPV亚型的感染率明显不同。例如,在细胞学正常人群中,全球感染率排前五位的HPV亚型为HPV 16/52/31/53/18,我国则为HPV 52/16/58/33/18;在低级别宫颈上皮内瘤样变(LSIL)患者中,全球感染率排前五位的HPV亚型为HPV 16/52/51/31/53,我国则为HPV 16/18/58/52/33;在高级别宫颈上皮内瘤样变(HSIL)患者中,全球感染率排前五位的HPV亚型为HPV 16/52/31/58/33,我国则为HPV 16/18/58/52/33;在宫颈癌患者中,全球感染率排前五位的HPV亚型为HPV 16/18/45/33/58,我国则为HPV 16/18/31/52/58。因此,对于HPV核酸筛查试剂,上述差异可能造成境内外临床试验受试人群的明显差异,导致境内外临床试验数据的显著差异。申请人应在境内补充临床试验。

例9:疾病分型和疾病病因等的差异。现有研究发现, 对于食管癌和肝癌等多种肿瘤,不同人种在肿瘤的病因、发病部位、病理特征和不同亚型分布等方面存在明显差异。例如,我国食管癌的主要病因是致癌性亚硝胺和某些真菌,而欧美食管癌的主要病因则为肥胖、胃食管反流和巴雷特食管;我国食管癌中鳞癌占95%,而欧美鳞癌只占30%;我国食管癌好发于上中段食管,而欧美食管癌多发于食管下 1/3 段。我国肝癌主要与HBV感染有关,而欧美则主要与HCV感染和酒精有关。另外,我国肝癌患者与欧美肝癌患者在流行病学、分子生物学特征、临床表现及分期上也具有明显差异。因此,对于预期用于食管癌或肝癌等的辅助诊断试剂,以及用于食管癌或肝癌等指导用药的PD-L1抗体等伴随诊断试剂,上述差异可能造成境内外临床试验受试人群的显著差异,导致境外临床试验数据不能外推至我国人群。申请人应在境内补充临床试验。

例10:体质和体内生理生化状态等的差异。例如,抗缪勒管激素定量检测试剂,可用于多囊卵巢综合征的辅助诊断。现有研究表明,境内外不同年龄段人群中抗缪勒管激素水平存在较明显的差异。我国年轻和中年女性的抗缪勒管激素水平低于白种人群,我国老年人抗缪勒管激素水平则低于美国黑种人,上述差异可能导致境内外不同年龄段人群参考区间不同,造成境内外临床试验数据的差异。申请人应按照中国人群的参考区间进行统计分析,以确认申报产品在中国人群的临床性能。

4.3、受试人群中病原体流行情况的差异

针对病原体检测试剂,境内外受试人群中病原体流行情况的差异可能造成境外临床试验所验证的病原体不能代表境内病原体的全部特征,导致境外临床试验数据无法支持申报产品在我国人群的使用。

例11:境内外病原体流行基因型的差异。例如,乙型肝炎病毒(HBV)基因分型检测试剂,用于辅助医疗专业人员了解患者的乙型肝炎病毒基因型别,以便确定适当的治疗方法。现有研究表明,HBV分为10种基因型(A~J)和34种亚型,且HBV基因型的分布存在人种和地域差异。我国常见基因型为B和C型,部分地区存在少数D型,黑种人中常见基因型为A、E和D型,白种人常见基因型为A和D型,基因型F是美洲爱斯基摩人的优势基因型,基因型G主要分布在西方国家,基因型H在墨西哥的高加索和蒙古人种中占主导地位,而基因型I和J则主要在亚洲人中发现。因此,申请人应关注申报产品声称的可检出基因型及境外临床试验所验证的基因型是否涵盖我国流行基因型,各基因型数量是否满足我国技术审评的要求。如未涵盖或不满足,申请人应视情况在境外或境内补充临床试验。

例12:境内外病原体流行菌种的差异。例如,用于对血液样本中细菌和酵母菌等进行培养和定性检测的血培养瓶。由于地域、环境、种族、基础疾病以及临床常用抗生素情况的差异等,境内外感染患者血液样本中的临床常见病原体种类可能不同,导致境外临床试验所检出的菌种并未完全覆盖我国临床常见的病原体菌种。另外,由于境内外临床常见菌种流行率的差异,针对某些在境内流行率较高、但在境外流行率低的菌种,境外临床试验检出的菌种数量可能不足以验证申报产品对我国境内流行菌种的检测性能。例如,现有研究表明,铜绿假单胞菌在加拿大的血流感染发病率为0.0036%,在我国则为7.2%。申请人应关注申报产品声称的可检出的病原体菌种及境外临床试验所覆盖的菌种是否涵盖我国常见病原体流行菌种,各菌种数量是否满足我国技术审评的要求。如未涵盖或不满足,申请人应视情况在境外或境内补充临床试验。

例13:境内外病原体耐药流行菌种的差异。例如,抗生素药敏试剂或病原体耐药基因突变检测试剂。由于地域、环境、临床抗生素使用情况及病原体基因型等的差异,境外临床试验所检出的耐药菌种类型可能并未完全覆盖我国临床常见的病原体耐药菌种类型。例如,肺炎克雷伯菌对碳青霉烯类抗生素的耐药机制之一是产生碳青霉烯酶。碳青霉烯酶包括A、B和D三大类,每大类又细分成各亚型。中国耐碳青霉烯类抗生素肺炎克雷伯菌主要产生KPC-2型碳青霉烯酶,西方国家则主要产生KPC-3型。申请人应关注申报产品声称的可检出的病原体耐药菌种及境外临床试验所覆盖的菌种是否涵盖我国病原体常见耐药流行菌种,各菌种数量是否满足我国技术审评的要求。如未涵盖或不满足,申请人应视情况在境外或境内补充临床试验。

5、临床试验样本和统计分析的差异

对于某些产品,境内外样本采集、保存和处理等的差异可能造成境内外样本质量的差异,导致境内外临床试验数据的差异。申请人应在我国境内补充临床试验。

对于某些产品,境内外临床试验结果的统计分析可能存在差异,导致境内外临床试验数据的差异。申请人应根据我国相关要求进行统计分析。

6、与我国具体产品指导原则的差异

申请人还应关注境外临床试验设计等是否满足我国相关产品指导原则的具体要求,如不满足,应视情况在境内或境外补充临床试验。

例14:我国《结核分枝杆菌复合群耐药基因突变检测试剂注册技术审查指导原则》要求,结核分枝杆菌耐药基因突变检测试剂,如选择药敏表型作为临床参考标准,还需对所有耐药/阳性样本采用分子生物学方法进行验证,以明确引起耐药的具体突变类型,验证申报产品对耐药基因突变的检测性能。

三、针对差异的处理

申请人应根据产品具体情况,详细分析境内外临床试验可能存在的各种差异,确认境外临床试验数据是否能够充分支持申报产品在我国注册声称的预期用途、是否满足我国注册申报临床试验的相关要求。

如经分析发现,境外临床试验数据充分支持申报产品在我国注册声称的预期用途,满足我国注册申报临床试验的相关要求,则可将境外临床试验数据作为在我国注册申报的充分临床证据。

如经分析发现,境外临床试验数据不能充分支持申报产品在我国注册声称的预期用途,无法满足我国注册申报临床试验的相关要求,则可将境外临床试验数据作为在我国注册申报的部分临床证据。申请人应视情况在我国境内或境外补充临床试验。

如经分析发现,境外临床试验数据完全不能支持申报产品在我国注册声称的预期用途,无法满足我国注册申报临床试验的相关要求,则境外临床试验数据不能作为在我国注册申报的临床证据。申请人应视情况在我国境内或境外按要求开展临床试验。

四、使用境外临床试验数据的相关资料要求

(一)申请人应明确境外临床试验数据的用途(如:用于申报产品的境外上市申报),境外临床试验数据是否完整、是否纳入中国人群数据,申请人及临床试验机构是否愿意接受我国药品监督管理局的监督检查。

(二)申请人应提交境外临床试验机构的伦理意见、临床试验方案和临床试验报告。伦理意见、临床试验方案和报告的提交形式、内容与签字签章等应满足当地临床试验质量管理的要求。申请人应提供完整的临床试验数据,不得筛选,临床试验报告应包含对完整临床试验数据的分析及结论。境外临床试验数据应真实、科学、可靠、并可追溯。

(三)申请人还应提交境内外临床试验的差异分析报告,应包括针对上述各种差异的分析与处理。

针对境内外临床试验质量管理要求的差异分析,申请人至少应提交:

1、境外临床试验机构的名称、所在国家(地区)及其符合当地临床试验质量管理的情况、遵循《世界医学大会赫尔辛基宣言》确定的伦理准则的情况;

2、境外临床试验所在国家(地区)有关临床试验质量管理的相关法律、法规、规范或标准等;

3、临床试验所在国家(地区)与我国体外诊断试剂临床试验质量管理要求的差异。

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    2021-08-31 黒鍵般的叛逆

    学习了

    0

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