10 tips to successfully manage China’s Clinical Trials Singularities
There has been a very quick progress in clinical trials in China to adapt to international standards, but there are unique features that should be considered for ensuring a successful outcome of these trials. Experience managing studies at an international level, local team expertise, clear communication, and an open approach to the studies are key elements when conducting clinical trials in China, but it will also be essential to properly manage China’s singularities.
Here is a review of some of the most remarkable:
NMPA (Regulatory Authority) can require setting up specific clinical trials with Chinese population (PK trials and /or confirmatory clinical trials) to support the results from ongoing foreign studies, or to validate drugs already approved at markets out of China.
- Face to Face Meetings.
Usual in Chinese culture. Visits to institutions (e.g. HGRAC) or Principal Investigator apart from the monitoring visits can be frequent.
- Reports from Regulatory and Ethics Committees (ECs).
Official reports can have information that can be interpreted. The actual requirements may be provided at informal contacts.
Hospitals in China are spread through thousands of kilometres so most sites can be at more than 1,000 km from Beijing. It is especially important at COVID-19 restrictions environment.
- COVID-19 restrictions.
Extreme restrictions were applied in the first half of 2020. Guideline from NMPA: (“Guidelines for the management of drug clinical trials during COVID-19 outbreaks”) to be followed.
Following the contract with the site, sites in China are paid in advance meaning patient visits are paid before they are performed. In case of payment delay, sites may stop study activities.
- Media and public opinion.
Clinical trials are followed by media and public opinion depending on the interest of the clinical trial, they can impact PI willingness of participation in the study.
The concept of out-of-scope costs sometimes may need to be reminded and followed up, e.g. informing immediately when there are significant out of scope costs.
Everything should be translated to Chinese as English is not commonly spoken and the Chinese version of the documentation is required by Institutions and ECs.
- Traditional Chinese Medicine.
Traditional Chinese Medication is commonly used. A specific list of TCM that can be used at the clinical trial will be appreciated by the Study Investigators.
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