When was the latest revision of the Clinical Research Emergency Handling Guidelines?

At present, the latest revision time of the emergency response guidelines for clinical research in different domestic subdivisions is not uniform. Among the two most commonly used national-level special guidelines in the industry, the latest revised version of the "Medical Device Clinical Trial Emergency Response Guidelines" issued by the Center for Device Evaluation of the State Food and Drug Administration for medical device clinical trials was issued on December 29, 2023. The latest revision time for the core guidelines related to drug clinical trial safety emergencies is July 2022.

Many new clinical research practitioners may be confused as to why the revision time of the guidelines in the same direction differs by one and a half years. In fact, the regulatory lines of drugs and medical devices are originally updated separately. There is no more authoritative statement about which one is more authoritative. For projects in the corresponding fields, just refer to the guidelines in the corresponding fields. Last month we monitored a new member of an oncology drug project team who found the wrong guideline and took the 2023 version of the guideline to determine the adverse event reporting process. However, he was slapped back by ethics and had to change it twice before passing it. It was a bit of a joke.

There are actually a lot of discussions in the industry now, especially in the past two years, there have been more and more trials of drug-device combinations and companion diagnostic combinations. When encountering cross-field clinical research emergencies, there are often disagreements about which guideline to refer to. I followed up on a multi-center trial of drug-loaded balloons last year. I have been in this situation. The sponsor believed that adverse events should be reported within 7 days according to the requirements of the drug guideline, but the Center for Ethics believed that device projects should follow the 5-day time limit of the 2023 version of the device guideline. The two sides argued for almost a week, and finally they went through the provincial bureau's communication channel to set unified standards.

In addition to national guidelines, the ethics committees of many medical institutions will also issue their own emergency handling rules for in-hospital clinical research. The update pace is more flexible than national guidelines. For a medical aesthetics IIT project I just accepted last week, the ethics committee of the tertiary A hospital where I worked just updated the hospital rules in March this year. It added a lot of new requirements for the handling process of sudden serious adverse reactions in subjects. The priority is higher than the national general guidelines. If you don't notice this, it is easy to get into trouble. Previously, a colleague doing IIT research did not check the latest ethics rules in advance. When minor adverse events occurred, they only submitted an electronic report according to national guidelines. They forgot the ethical requirement to provide paper instructions within 24 hours, and were almost suspended from the project qualifications. It took a lot of effort to recover.