Writing in the special December 2022 edition of DIA’s Global Forum magazine – which focuses exclusively on decentralised clinical trials – on behalf of the DIA China Digital Health Community (DHC), Takeda’s Alicia He and Pfizer’s Mia Sun examine the progress made on decentralised and digitalised trials in China.
The concept of DCT is attracting more and more attention in China. The paper Expert Consensus on Decentralized and Digitalized Clinical Trials, jointly written by the DIA China Digital Health Community (DHC) and Shanghai Pharmaceutical Association, was recently published (in Chinese) in the Chinese Journal of New Drugs and Clinical Remedies. DCT stands for not only decentralised clinical trial but also digitalised clinical trial in China.
Regulatory Framework
In August 2022, China’s Center for Drug Evaluation (CDE) published three draft guideline documents on patient-centric clinical trials. CDE cited the referenced expert consensus paper in the draft guideline on implementing patient-centric clinical trials. Decentralised clinical trials, patient experience data, and clinical outcome assessment are the keywords in these draft guidelines. They cover clinical trial design, implementation, and benefit-risk evaluation:
- Technical Guidance for the Design of Patient-Focused Clinical Trials (Draft) (in Chinese)
- Technical Guidance for the Implementation of Patient-Focused Clinical Trials (Draft) (in Chinese)
- Technical Guidance for Benefit-Risk Assessment of Patient-Focused Clinical Trials (Draft) (in Chinese)
All experts agreed in the consensus paper that DCT implementation requires technical/digital solutions as well as a clinical trial team to best serve the patients, and that either fully remote or hybrid remote (remote and on-site combined) can achieve the goal of patient-centricity. The paper provided a comprehensive model of the DCT digital platform.
Unique advantages and different approaches in China
What are the differences between DCT implementation approaches in China and abroad?
On this point, the experts’ opinions are relatively consistent. One major difference is the organisational structure of medical hospitals or institutions where most clinical trial activities take place. In China, the Clinical Trial Institutional Office in the hospitals has broader authorities and greater responsibilities in clinical trial governance and management compared with most Western countries.Differences are also reflected in other aspects:
Medical resources: Medical resources are concentrated in top-tier and second-tier cities. As a result, clinical trial sites are also concentrated in such cities. Regulatory requirements: Clinical trials in China must follow guidance from the National Medical Products Administration (NMPA) and the Human Genetic Resources Administration of China (HGRAC).
Patient preferences: Patients may prefer to go to big hospitals in big cities for medical treatments, particularly for difficult and/or complicated medical conditions.
Personal information processing: China has recently published laws and regulations to govern personal information handling, such as:
- China Cybersecurity Law (in Chinese)
- China Data Security Law (in Chinese)
- China Personal Information Protection Law (PIPL) (in Chinese)
The PIPL provides for Cross Border Data Transfer (CBDT) by specifying requirements for cross-border transfer of all personal information data.These differences will require careful consideration particularly when regulatory submissions outside China using data generated from such trials are planned.
Read the full article on the DIA Global Forum website
