医疗器械的上市前评估：向德国伦理委员会提交的临床研究的横断面分析。

Premarket evaluation of medical devices: a cross-sectional analysis of clinical studies submitted to a German ethics committee.

机构信息

Department of Non-Drug Interventions, Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.

出版信息

BMJ Open. 2019 Feb 22;9(2):e027041. doi: 10.1136/bmjopen-2018-027041.

DOI:10.1136/bmjopen-2018-027041

PMID:30798319

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6398724/

Abstract

OBJECTIVE

To assess the methodological quality of pre-market clinical studies performed on medical devices (MDs), including in-vitro diagnostic (IVD) MDs, in Europe.

DESIGN

Observational cross-sectional study.

SETTING

A large German ethics committee.

MATERIALS

From the consecutive sample of study applications between March 2010 and December 2013, we selected MD study applications requiring approval by an ethics committee and the competent federal authority. These included pre-market studies on devices that had not yet received a CE (Conformité Européenne) mark or had previously been CE marked for a different indication. Also included were post-CE studies requiring federal authority approval because the study entailed additional invasive or otherwise burdensome components.

PRIMARY AND SECONDARY OUTCOME MEASURES

Besides the design of the studies, we assessed the planned sample size, study duration and other aspects.

RESULTS

122 study applications were analysed: 98 (80%) concerned therapeutic rather than diagnostic devices and 84 (69%) were pre-market studies. The proportion of studies on class I, IIa, IIb and III devices was 10%, 15%, 28% and 39%, respectively. 10 studies (8%) investigated IVD MDs. A randomised controlled trial (RCT) was planned in 70 (57%) of the 122 applications; studies with non-randomised control groups (n=23; 19%) or without controls (n=29; 24%) were less common. In the sub-group of pre-market studies on therapeutic devices, the proportion of RCTs was 66% (43/65). The median sample size was 120 participants or samples (IQR 53-229). The median study duration was 24 (14-38) months. 87 studies (71%) considered at least one patient-relevant outcome. 12 (17%) and 37 (53%) of the 70 RCTs applied a fully or partially blinded design, respectively.

CONCLUSION

A large proportion of MD studies in Germany apply a randomised controlled design, thus contradicting the industry argument that RCTs on MDs are commonly infeasible.

摘要

目的

评估在欧洲进行的医疗器械（MDs），包括体外诊断（IVD）MDs 的上市前临床研究的方法学质量。

设计

观察性横截面研究。

地点

德国一家大型伦理委员会。

材料

从 2010 年 3 月至 2013 年 12 月连续的研究申请样本中，我们选择了需要伦理委员会和联邦当局批准的 MD 研究申请。这些研究包括尚未获得 CE（欧洲符合性）标志或先前为不同适应症获得 CE 标志的设备的上市前研究。还包括需要联邦当局批准的 CE 后研究，因为该研究涉及额外的侵入性或其他繁重的部分。

主要和次要结果

除了研究设计外，我们还评估了计划的样本量、研究持续时间和其他方面。

结果

分析了 122 项研究申请：98 项（80%）涉及治疗性而非诊断性设备，84 项（69%）为上市前研究。I 类、IIa 类、IIb 类和 III 类设备的研究比例分别为 10%、15%、28%和 39%。10 项研究（8%）调查了 IVD MDs。122 项申请中有 70 项（57%）计划进行随机对照试验（RCT）；非随机对照组研究（n=23；19%）或无对照组研究（n=29；24%）较少。在治疗性设备上市前研究的子组中，RCT 的比例为 66%（43/65）。中位数样本量为 120 名参与者或样本（IQR 53-229）。中位数研究持续时间为 24 个月（14-38 个月）。87 项研究（71%）考虑了至少一项与患者相关的结果。70 项 RCT 中有 12 项（17%）和 37 项（53%）分别采用了完全或部分盲法设计。