Challenges To Clinical System In China

In the past five years, the Clinical Trial has increasingly developed in China. When looking at the data from China CDE (Center for Drug Evaluation), we can see the number of Clinical Trials registered in CDE of 2021 has been more than twice of the number of 2017. The change is not only on the registration number. The new version of China Good Clinical Practice (GCP) has been issued in 2020, which has set a higher request to the quality of clinical trials running in China. Also in 2020, The State Council, China's cabinet, published a regulation on the management of human genetic resources, to supervise the systems with human genetic information in a strict process. With all these changes, the clinical system providers are accommodating in China markets to meet the challenges.

In the new version of China GCP, it has clearly pointed out the requirements of Clinical System Validation to ensure data integrity. The sponsors will pay more attention in vendor selection of clinical systems, represented by EDC, IRT, etc. Global big branding vendors have advantages in managing validation processes and documentations, and showed great competitiveness.

In another way, according to the regulation on the management of human genetic resources, if any system provider is Foreign organizations and domestic institutions founded or controlled by foreign entity, and the system will collect, store, use and provide human genetic information, then the system provider need go through a declaration process with sufficient information, and wait for a few weeks for approval. As every minute counts in a clinical trial, the sponsors then start to look at China local clinical system vendors with reliable quality, to save the time on additional declaration process. Additionally, with the Data Security Law of the People’s Republic of China taking effective on September 1st 2021, it further strengthen the protection of data exporting, it will impact the IT strategies of China Pharma or Biotech companies in clinical system architecture.

"In the new version of China GCP, it has clearly pointed out the requirements of Clinical System Validation to ensure data integrity"

If a clinical trial is carried out in multiple countries, the global system vendors will show the advantages of their global support and experiences in facing inspections. For the China-only trials, local vendors could provide quicker local support and save time for human genetic resources declaration, and usually with a lower cost for setup. Considering the increasing amount of new clinical trials in China every year, and the request for more remote tools due to COVID-19’s impact, we all can see a good time of clinical systems together with challenges.