The product label for clinical trials should indicate “Only Use for Clinical Trial.” Product label verification is an important audit step for hospital QC in clinical trials.Takeaway: Inappropriate descriptions on product labels for clinical trials, such as “NOT FOR HUMAN USE” or “NOT FOR CLINICAL USE”, should be avoided.
Single site is not recommended for medical device clinical trials. As per China GCP requirements, at least two sites should be considered for clinical trials in China. Please note that the China Fast Track pathway offers great opportunities to discuss with NMPA on protocol design, site selection, sample size, etc.Takeaway: Consider multi-center study design when planning a clinical trial in China
The determination of sample size in a medical device clinical trial requires comprehensive understanding in the related medical field, study design, statistical methodology, information collected on the subject device, threshold established for alternative treatment modalities, country-specific regulation, overall global regulation, etc. BradyKnows will assess all available information on the investigational product and work closely with PIs and statisticians to develop a reasonable and justifiable sample size for your planned study in China.Takeaway: Sample size determination is a complex process that requires input from multiple professional areas.
As per Regulation on the Administration of Human Genetic Resources (State Council, Order No. 717, effective since July 1, 2019), the Ministry of Science and Technology of China (MOST) is responsible for administering HGR materials and information. The sponsors involving foreign stakeholders should apply to HGRAC filing and obtain approval from MOST.Takeaway: HGRAC filling, or approval is legally binding in China. READ MORE > https://www.bradyknowsmedical.com/category/faq2/hgrac/
Adverse events: unfavourable medical events that occur during clinical trials, regardless of whether they are related to experimental medical devices.Serious adverse events： deaths or serious deterioration of health that occur during clinical trials, including fatal diseases or injuries, permanent defects of body structure or body function, need for hospitalization or prolonged hospitalization, and need for medical treatment or surgery Intervention to avoid permanent defects in body structure or body function; events such as fatal distress, fatal death, or congenital abnormalities or congenital disabilities.In China, CTCAE (Common Terminology Criteria for Adverse Events) is usually used for judging AE severity as Grade 1, Grade 2, Grade 3, Grade 4, and Grade 5. All AEs should be recorded in the Original Medical Record and CRF in a timely and accurate manner. SAE should be reported to the GCP office of the clinical study site, IRB, local NMPA, and local Health Commission within 24 hours.Takeaway: SAE report is of a stringent timeframe, which should be done in 24 hours.