Discussion on innovative medical device clinical trials: feasibility tests

Medicine saugust 14As the domestic industry upgrades and transforms
the state strongly encourages innovation, which also includes policy support for medical devicesThe state has promulgated relevant policies and regulations to encourage innovation, such as the Special Review Procedure for Innovative Medical DevicesMedical devices need to be registered for marketing, which is the most basic requirement of national regulationfor innovative therapeutic medical device products, because of its more innovation point, high potential risks, simpleliteratureand related clinical data difficult to explain its safety and effectiveness, so for the vast majority of innovative medical devices, through clinical trials for registration and marketing, is the only way for such deviceshowever, due to the high degree of innovation of innovative medical devices, some innovation points are not reflected in previous clinical studies:1There are significant differences between the clinical data of the past and the innovative device itself, and the use of this type of data for speculation, it is not possible to reasonably predict the "true value" of innovative devices, i.ethe calculation The "estimate" and the "real value" of the device itself are far from the "real value" of the device itself, making the clinical trial uncontrollable as a whole, and2The evaluation method sandand and safety of the device innovation point, the evaluationstandard , etc., are not applicable, which makes it impossible to evaluate the relevant evaluation methods and evaluation standards for the innovative products How to obtain the relevant clinical data at this time, how to evaluate the safety effectiveness of the relevant, will be the future confirmed clinical trial success of one of the core points feasibility test
it is precisely because of the existence of the above-mentioned difficulties, innovative medical devices if directly confirmed test, will make the overall test become uncontrollable, or even ultimately can not come up with reasonable relevant test results Therefore, before the formal and forensic clinical trials, whether feasibility tests need to be conducted is the primary consideration of innovative therapeutic medical devices entering the clinical stage Innovative therapeutic medical devices, since they are innovative, are bound to be different and this innovation is both an advantage and a potential hazard and a risk point Because of whether new innovations lead to new risk points, and while there is enough non-clinical data to support them, it is difficult to cover the full range and it is not possible to fully predict all the risks in advance before they are officially entered into human use therefore, for the declaration registration of highly high-risk products, the State is mandatory for feasibility testing (for example: Bioabsorbable coronary drug elution stent clinical trial guidelines provide for one of the following situations require feasibility testing: 1 The applicant has not yet bio-absorbable coronary drug elution stent approval for listing, declared products for the enterprise spending the first time to apply for the application Available bioabsorbable drug stent products; 2 The applicant has bioabsorbable coronary drug elution stent approved for listing, declares new bio-absorbable drug stent products on the market, but the product drug (including the introduction of new derivatives), coating (ingredients, proportions, etc.), polymer stent platform (ingredients, proportions, etc.) when compared to the approved product changes Such products include catheter-implanted artificial aortic valves, bioabsorbable coronary drug elution stents, aortic cladding stent systems, etc but can a product that requires feasibility testing a non-
regulation can be completely unfeasible? On the face of it, feasibility tests extend the registration cycle and increase the cost of product registration However, feasibility tests can also roughly verify the safety and effectiveness of the product at an early stage, allowing for some unpredictable risks to be avoided this is necessary for some highly innovative medical devices Although the feasibility test will extend the registration cycle and increase the cost, but because the feasibility test sample size is not much, the number of centers is not much, compared with hundreds of cases of multi-center confirmed clinical trials, its cost of time and economic cost is low, it is still a low-cost risk-averse approach And whether successful or unsuccessful, can provide the corresponding experience and basis if the actual risk of the product is too high to lead to the failure of the feasibility test, can stop in time, avoid more human costs, time, economic losses, on the other hand, although the feasibility test has failed, but also according to this test to provide relevant data to further improve the product or improve the relevant clinical trial-related design If the feasibility test is successful, the data may also provide evidence for the determination of the design of the next corroboration test summarize need to be specifically analysed on the question of whether feasibility tests are needed In terms of different types of innovative products, whether feasibility tests are required, depending on the product situation and the enterprise's own situation For products with low degree of innovation or enterprises have a high degree of confidence in their own products, and there are no mandatory regulatory requirements, you can also skip the feasibility test, directly into the corroboration test However, for highly innovative medical devices, such as treatment methods, innovation in the use of methods, or the product itself is a high lysing medical device, it is still recommended to conduct a small sample feasibility test, so that the relevant potential risk factors can be exposed, so that the safety and effectiveness of the device is initially verified author: Ozida Medical Device services group Clinical Research Division