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There is no precedent for innovative medical devices. How to design clinical trial plan

There is no precedent for innovative medical devices. How to design clinical trial plan

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  • Time of issue:2020-12-08
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(Summary description)There is no precedent for innovative medical devices. How to design clinical trial plan

There is no precedent for innovative medical devices. How to design clinical trial plan

(Summary description)There is no precedent for innovative medical devices. How to design clinical trial plan

  • Categories:News
  • Author:
  • Origin:
  • Time of issue:2020-12-08
  • Views:0
Information

The success of clinical trials requires strict trial design. Randomized controlled clinical trial is the "gold standard" of clinical research. The clinical research of medical devices, especially the confirmatory clinical trials providing key evidence, generally adopts randomized controlled design.
For innovative medical devices, well-designed randomized controlled trials are still the first choice. When randomized controlled trials are not feasible, single target clinical trials can be used as an alternative strategy and provide key evidence for product registration. In the single group target value test, the determination of the target value needs a solid scientific basis, the inherent limitations of the single group design should be considered, and the target value should be estimated conservatively.
For highly innovative products, it is difficult to reasonably predict the real effectiveness of products, or there may be risks that are difficult to predict in advance. Therefore, it is a reasonable strategy to carry out small sample feasibility test before confirmatory test.
At present, China's medical device industry has entered a period of rapid development. In order to encourage enterprises to develop and innovate medical devices, in 2018, the State Food and Drug Administration issued the newly revised "special evaluation procedure for innovative medical devices". The implementation of the measures is conducive to promoting the popularization and application of new technologies of medical devices and promoting the healthy and rapid development of China's medical device industry.
At present, there are three ways of clinical evaluation of medical devices before marketing in China: clinical trial exemption, comparison of the same variety and clinical trial. The clinical trial exemption of medical devices is basically feasible, but it is not feasible for low-risk medical devices. According to the requirements of technical guidelines for clinical evaluation of medical devices, medical devices listed through the same product comparison path must be analyzed and evaluated by using the data of clinical trials or clinical use of similar medical devices. However, innovative medical devices are novel. Generally, there will be no similar products on the market, which is often not feasible. Therefore, for the vast majority of innovative medical devices, clinical trial path has become an inevitable choice.
For innovative clinical trials of medical devices, clinical trial scheme design is an important link. Medical device innovation often has no precedent. How to fully evaluate the effectiveness and safety of products through clinical trials, and how to reflect the characteristics and advantages of medical device innovation are the key issues to be considered in the design of clinical trial scheme..

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