Episode 4: Clinical Evaluation vs. Clinical Trials

Clinical Evaluation or Clinical Trials?

As mentioned in Episode 1, before the concept of "clinical evaluation" existed, medical devices were often required to undergo clinical trials (whether under the name of clinical trials or clinical verification) prior to market launch to obtain their own clinical application evidence. In reality, most medical devices preparing for market launch are improved based on already marketed products. For devices with mature technology, extensive clinical application, and non-high clinical risks, it is entirely possible to find marketed products with the same scope of application and similar technical characteristics, thereby leveraging "stones from other hills." The path to market launch has changed from "must pass the graduation exam yourself" to two paths: the first is "pass the graduation exam yourself," and the second is "prove with your usual grades that you have the same level of knowledge mastery as the top student (equivalent device), and you can cite the top student's graduation exam score when graduating, without needing to take the exam again." Both paths are collectively referred to as "clinical evaluation."

I. Definition of Clinical Evaluation

The "Guiding Principles for Medical Device Clinical Evaluation Technology" issued by NMPA (No. 73 Announcement of 2021, Appendix 1) defines clinical evaluation as: "A continuous activity of analyzing and evaluating clinical data using scientific and reasonable methods to confirm the safety, clinical performance, and/or effectiveness of a medical device within its scope of application."

This definition contains three key elements:

The "Clinical Evaluation Report" (CER) is the outcome of clinical evaluation. The CER in the registration application dossier is generated at the registration time node, summarizing the clinical evidence that the medical device complies with the "Essential Principles of Safety and Performance of Medical Devices," to prove the safety, clinical performance, and/or effectiveness of the medical device within its scope of application.

II. Definition of Clinical Trials

The NMPA regulatory system provides two definitions for clinical trials, applicable to different regulatory contexts.

01. Context of "Good Clinical Practice for Medical Devices"

02. Context of Clinical Evaluation

III. Relationship Between Clinical Evaluation and Clinical Trials

Article 24 of the "Regulations on the Supervision and Administration of Medical Devices" (State Council Decree No. 739) stipulates: Class II and Class III medical device registration shall submit clinical evaluation materials. Clinical evaluation can be completed through equivalent device data, literature/empirical data, clinical trial data, or a combination thereof. It can be seen that clinical trial data is only one type of data used in clinical evaluation. Equivalent device data, literature/empirical data, and non-clinical data (such as bench testing, animal testing, etc.) can all be used for clinical evaluation.

The relationship between clinical evaluation data and clinical trial data can be summarized as: clinical trial data is a part of clinical data, and clinical data is a part of the input for clinical evaluation. Obviously, from a data perspective, the level of the clinical evaluation concept is higher than that of the clinical trial concept. If you hear someone say that a product cannot be launched through "clinical evaluation" and must conduct "clinical trials," this confuses the hierarchy of the two concepts.

IV. The Role of Clinical Trials in Clinical Evaluation

Clinical trials are an important tool for clinical evaluation. For high-risk medical devices, innovative medical devices, or when suitable equivalent devices cannot be identified, clinical trials need to be conducted to obtain direct evidence of the safety and effectiveness of the product under clinical use conditions.

Clinical trials conducted at different time points provide multi-layered data for clinical evaluation:

Clinical evaluation reports often present clinical trial results in the form of abstracts while analyzing and discussing clinical trial data, adverse events, etc., to demonstrate whether the product is safe and effective.

V. Conclusion

Clinical evaluation is the activity of confirming the safety, clinical performance, and/or effectiveness of a medical device within its scope of application, and is a systematic, multi-layered evidence integration process. Clinical trials are a high-level clinical data generation method used when existing evidence is insufficient to confirm the safety and effectiveness of the medical device, and their results are part of the input for clinical evaluation.

We need to formulate a clinical evaluation plan based on product characteristics, risk levels, and available clinical data resources. When clinical data resources do not meet the needs of clinical evaluation, clinical trials should also be conducted to ensure a comprehensive evaluation of the safety and effectiveness of the product and meet regulatory requirements, thereby achieving smooth market launch and the ultimate goal of continuously safeguarding public health.

Dr. Zhang Jiange (ORCID: https://orcid.org/0000-0003-2182-8686)