I wanted to share some insights about the medical device clinical trial procedure in China.
NMPA (CFDA) requires clinical trials for Class III and Class II medical devices unless the product is listed on the clinical exempt catalog. (NMPA published the "Clinical Exemption Catalog for Medical Devices" on Sep 30, 2018 in which a total of 855 medical devices and 393 IVDs exempted from clinical trial.)
** Please note that, since clinical trials are expensive and time consuming, clinical evaluation report (CER) and overseas data can be assessed and applied as alternatives to clinical trials.
To conduct a clinical trial in China, manufacturers need to follow the "Medical Device Clinical Trial Quality Management Practice" (China Medical Device GCP), published on March 1, 2016. The figure below shows the workflow of conducting clinical trials in China from the initial study protocol design to the final reporting.
Below highlights a few of the key steps to pay attention to:
- Sample size: Patient Number
It is very important to determine the appropriate number of patients needed for the clinical trial. If the number is too small, NMPA may require more data in the registration supplement phase, which may delay the manufacturer's registration timeline and China market entry. If the number is too large, the clinical trial could cost more money than needed.
The accurate and reasonable patient number will be determined based on the product's safety and effectiveness profile and statistical calculation.
- Patient Recruitment
If manufacturers intend to indicate all the indications with NMPA, patients referring all the indications need to be recruited in China. The recruitment distribution among all the indications is mainly determined by the curing rate of patients treated with the proposed medical devices or IVDs for different indications. The recruitment distribution will also impact the costs of the study. For example, for wound therapy devices, it is easier and cheaper to recruit patients with burn wounds than patients with venous ulcers wounds.
Manufacturers also need to understand that to recruit multiple types of patients, multiple investigators will be needed to conduct the clinical trials because a certain wound type may belong to a certain independent department in Chinese hospitals. For example, burn and traumatology are two independent departments in Chinese hospitals.
- Clinical Trial Monitoring and Coordination
During the study implementation stage, it needs to be clarified that site management is conducted by two functions: Clinical research associate (CRA) and Clinical trial coordinator (CRC). CRA will be sent by CMD to conduct site visit monitoring. CRC represents the site and needs to be involved in the whole process of clinical trials to assist investigators.
- Patient Follow-up
Patient follow-up after the treatment is a key segment of clinical trials.
- Institutional Review Board Approval
Clinical trials in China need to be approved by local Institutional Review Board (IRB). Once the IRB approval is obtained, manufacturers can sign the clinical trial agreement with sites.
- Clinical Trial Filing
Another key step before the study initiation is to submit a clinical trial filing to the provincial NMPA offices. With an IRB approval, the local provincial agency approval will be easy.
- Human Genetic Resources Declaration
It is required by NMPA that clinical trials involving the use of human genetics, human blood, organ, tissues and cells need to submit a declaration to the Human Genetic Resource Department of China. This is the last step before study initiation.
I hope this was helpful. Has anyone ever gone through and/or are currently going through the clinical trial process in China? I'd love to hear about your experience(s).
If you have any questions or want more information, feel free to send me a message or email at gpalma@chinameddevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------