Practice and Reflection on the examination and approval of Clinical Trials for Innovative Medical Devices
Recently, the Fourth Evaluation Department of the Center for Medical Device Evaluation (hereinafter referred to as “the Center”) evaluated the clinical trial approval application of the “degradable magnesium endosseous fixing screw” product in the special approval process of innovative medical devices.
During the technical review of the clinical trial approval project of “degradable magnesium endosseous fixing screw”, the Center found the following problems and made preliminary comment for research:
1. For the innovative medical devices which need the clinical trial approval, especially the “world new” innovative medical devices, there are difficulties to achieve that “clinical trial shall be carried out within one year after the issue of the registration inspection report”.
The Article 7 of the Norms on the Quality Management for the Clinical Trials of Medical Devicesprovides that “before the clinical trial, the applicants shall complete the preclinical study of medical devices for the trial, including...... and acquire the product registration qualification test report issued by accredited test institutions within one year”. For the innovative medical devices, especially the “world new” innovative medical devices, and due to the lack of universally accepted review and reference methods, the applicants may be required to supplement preclinical research information during the approval of the clinical trial, and such studies often take plenty of time to complete. Moreover, after the applicants complete the registration inspection, it also takes significant amount of time to pass the ethical review of several clinical trial facilities and sign the agreement. Therefore, for the innovative medical devices which need the clinical trial approval, there are difficulties to achieve that “clinical trial shall be carried out within one year after the issue of the registration inspection report”. In the meantime, the Administrative Measures for Medical Device Registration provides that for the application of clinical trial approval, the applicants will be given one year to supplement the needed information. And the applicants can conduct clinical trial within three years after getting the approval documents of the clinical trial. It is recommended to take the stipulations on relative time nodes of clinical trials in applicable laws and regulations into account and specify the time limit requirements of feasible clinical trials.
2. For innovative medical devices, opinions from all clinical trial facilities and the ethic committee need to be submitted during the clinical trial approval, which may result in repetitive work of the applicants.
Enterprises intend to revise the clinical trial protocol according to the consensus of the conference, which will need repetitive work to re-pass the review of many clinical trial facilities. For the global pioneering products, the science of the clinical trial design will face more challenges. Thus, the design shall be discussed and seriously considered by the regulatory agencies, test agencies and clinical experts. To avoid repetitive work of the applicants, and considering that the Norms on the Quality Management for the Clinical Trials of Medical Devices has explicitly provided that in a multi-center clinical trial, the ethic committee shall take the lead in reviewing the ethical rationality and scientificity of the trial protocol, and ethic committees of the other test facilities are responsible only for reviewing the feasibility of the trial in each facility. It is suggested that only the opinions from the ethic committee need to be submitted during the clinical trial approval.
3. The appropriate requirements of clinical trial approval for preclinical research information shall be studied.
From the perspective of risk control, it is necessary to focus on the basic safety study of the product during the review of the clinical trial approval. And for research materials need to be further supplemented, it is necessary to make clear that what need to be done before clinical trials, and what need to be done before the product registration.
Provided the products are safe and effective, we are able to timely transform the global-leading science and technology into clinical usable products. On the one hand, this demonstrates our ability to apply science and technology to practical use, on the other hand, it also reflects that the self-improved supervision can promote and adapt to the scientific development. New products and new technologies often bring challenges to existing approaches and methods of review, while promising significant clinical benefits in some certain fields, they may also lead to new risks . It is urgent to find out how to further and comprehensively identify, effectively control and establish the risk review system, and to establish regulatory theory and regulatory system that can adapt to the transformation of technical innovation of medical devices.