Around the Globe

China: Introduction to Consensus Document on Clinical Trial Management
in Pandemic
Zhongyuan Xu
Research Center for Clinical Pharmacology, Nanfang Hospital
Southern Medical University

stablished and organized by the Committee for Drug Clinical Evaluation Research (CDCER) of the Chinese Pharmaceutical Association (CPA), the China Forums of Clinical Research Capacity Building and Human Research Participants Protection known as CCHRPP brought together a majority of representatives from hospital clinical research centers, the R&D-based Pharmaceutical Association Committee (RDPAC), research sponsors, contract research organizations (CROs), and site management organizations (SMOs), to share clinical resources and improve communication efficiency, especially during the current pandemic. More than 120 facilities throughout China have become CCHRPP members since 2017.

As a leading organization devoted to clinical science and research in China, the CDCER recommended that the CCHRPP organize a group of medical experts from non-profit, academic, and industry research organizations to draft an expert consensus document for clinical trials during the pandemic. (See accompanying list of participating organizations.)

This expert consensus document is a summary of their relevant experience as recommended prudent practices for conducting clinical research. It was conceived and compiled by experts in China, based on the initial experience in the country. At the time this was published in February 2020, there was no large-scale COVID-19 outbreak outside of China, so this document does not refer to relevant ICH GCP.

This is not a government regulation or other type of official government document; adherence is voluntary. Guidelines subsequently issued in the US (by FDA) in March 2020, in the European Union (by EMA) in April 2020, and in China (by NMPA, formerly CFDA) concur with many of the experiences and opinions expressed herein.

Download the CCHRPP Consensus Document on Clinical Trial Management in Pandemic

Organizations Contributing to Consensus Document Development

Astellas Pharma (China) Inc.

Bayer Healthcare Co., Ltd.

Beijing 360CQA Ltd.

Beijing Bairui Law Firm

Beijing Youan Hospital, Capital Medical University

China PLA General Hospital

Guangdong Provincial People’s Hospital

Hunan WeTrial Medical Information Co., Ltd.

Jiangsu Province Hospital

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Nanfang Hospital, Southern Medical University

Peking Union Medical College Hospital

Pfizer Dalian Pharmaceutical Plant

Qilu Hospital of Shandong University (Qingdao)

Renji Hospital, Shanghai Jiaotong University, School of Medicine

Shanghai General Hospital

Shanghai Mental Health Center

Shenzhen People’s Hospital

The Affiliated of Qingdao University

The First Hospital Affiliated to Army Medical University

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology