Analysis of Common Clinical Verification Issues for In Vitro Diagnostic Reagents

In vitro diagnostic reagents clinical trials refer to the systematic study of the clinical performance of in vitro diagnostic reagents in their corresponding clinical conditions. They are the last stage of research and development used in clinical applications to guide the effectiveness and safety of clinical treatment. The trial data and results are important basis for registration evaluation and approval by the regulatory department.

Ethics of In Vitro Diagnostic Reagents

In terms of ethics, the entire ethical review system for IVD reagents clinical trials is not yet mature compared to drug clinical trials. Currently, it is generally based on the method of drug clinical trials as a reference standard, and ethical review is generally conducted by the ethics committee of drug clinical trials, ignoring the unique characteristics of IVD reagents clinical trials.

In vitro diagnostic reagents clinical trials started relatively late in the entire clinical trial field, and related laws and regulations are gradually being improved. Some ethics committee members lack experience in reviewing in vitro diagnostic reagents clinical trials, and even know little about the product characteristics, which weaken the ethics committee's review ability as the most important link in reviewing medical device clinical trials, leading to problems for clinical trial researchers in finding reasonable basis during ivd diagnostic reagent operation, and resulting in a decline in the quality of clinical trials.

How to improve the quality of ethics committees' review of IVD reagents clinical trials and ensure their smooth progress? Firstly, it is recommended that ethics committees should start from the actual situation of the research, draw on the experience of domestic and foreign hospital ethics committees in reviewing IVD reagents clinical trials, invite related personnel experienced in in vitro diagnostic reagents clinical trials to be members of the ethics committee, and formulate a set of operating procedures suitable for the hospital to carry out in vitro diagnostic reagents ethical review. Secondly, it is recommended that ethics committee members and research personnel at all levels of the hospital receive training on relevant laws, regulations, and policies regarding IVD reagents clinical trials, increase their understanding of ethics, and continuously improve and customize the review process according to the characteristics of different products during the review process. Finally, it is recommended that ethics committee members fully understand the entire clinical trial process, strengthen ethical review, and strictly review every key aspect involved in the clinical trial plan to ensure the quality of the clinical trial.

Organization and Personnel of In Vitro Diagnostic Reagents

With the passage of time, drug clinical trial institutions have made qualitative leaps in terms of qualification recognition, institutional construction, and supervision, and have continuously promoted the innovative development and overall level of drug clinical trials. Institutions and personnel are the basis for ensuring whether a clinical trial is compliant. Having a complete clinical trial management institution is the basis for guaranteeing that the clinical trial is conducted in compliance; trained and experienced researchers are the guarantee for the smooth completion of the clinical trial.

With the development of science and technology of in vitro diagnostic solutions, in vitro diagnostic products are becoming more and more widely used. Medical device clinical trial institution management is also gradually becoming standardized. In the stage where regulations are continuously improved and updated, there are still many problems in on-site inspections, mainly including:

• The division of labor among personnel participating in the trial is unclear. The sponsor and investigator are the main leaders of the clinical trial, and they lack understanding of the process of conducting the IVD reagents clinical trial. Most sponsors think that as long as they provide the trial institution with relevant materials or instrument and equipment needed for the trial, they can obtain approval. No supervisor or appointed supervisor is seen throughout the trial to conduct supervision on relevant trial processes.

• The researchers are not familiar with the quality management regulations and standards of the clinical trial, there is no perfect training mechanism, and there is a lack of communication and understanding between the applicant and the investigator. The researchers are not familiar with the operating procedures of IVD clinical trials, and they do not understand the characteristics of the IVD in vitro diagnostic reagents products, ignoring the quality of the trial, and failing to effectively identify the potential problems that may exist in clinical trials.

• Supervision and clinical data recording tend to be formalized, and cannot objectively and comprehensively reflect the entire quality control process of the trial, directly leading to a decline in the quality of the clinical trial.