Meeting Highlights: DIA China 2023
Expanding Patient Engagement and Patient Centricity in Clinical Trials in China
Shuting Li
Anhui Jimin Cancer Hospital
Xinfang Fan
Bayer Health Care Ltd.

n recent years, with the Chinese government’s vigorous support and all-round promotion for innovative drugs, more than 3,000 clinical trials with investigational drugs have been conducted annually. In this context, patient engagement has become increasingly important, and how to keep patients informed of progress in drug development and actively participating in clinical trials has become a hot topic in the pharmaceutical industry.

A recent survey conducted by a Chinese R&D clinical research organization among patients, their families, and investigators in China focused mainly on “the understanding of clinical trials,” “the channel to get information about clinical trials,” “the difficulty of patient enrollment,” and “how to initiate clinical trials quickly.” The survey contained eleven (11) single-choice questions and five (5) multiple-choice questions and received 5,832 total responses. Eighty-one percent of the patient-respondents knew about clinical trials, indicating broad public awareness of this concept. However, 37% of these same patient-respondents were unwilling to participate in clinical trials due to their concerns about the risk of investigational drugs; 67.2% of the physician-respondents also believed that patients were afraid of participating in the clinical trials for safety reasons. Insight into the underlying causes of patients’ unwillingness to participate in clinical trials is essential for improving patient engagement.

Another company has found an avenue into understanding patient engagement by conducting patient interviews, in an early phase of a trial for an investigational drug, in members of the target population who have no clinical trial experience in China. While not intended for publication, these interviews have helped this company identify the feasibility of trial conduct in terms of timing and environment that are suitable for potential trial participants, and to identify key differences in disease awareness and recognition between patients in China and in other countries. The results of these interviews have helped guide this company’s China study team to modify their clinical development strategy in China.

The importance of educational programs that help more patients understand the scientific rationale of clinical trials to improve patient engagement and treatment compliance is also growing in China. Identifying, selecting, and informing potential trial participants is also essential for regulatory compliance.

On International Clinical Trials Day (May 20) 2023, several hospital-based clinical trial institutions in China conducted various activities to publicize and educate people about clinical trials. For example, the Cancer Hospital of the Chinese Academy of Medical Sciences organized on-site and online activities, including free consultations and science lectures, which welcomed more than 30,000 participants. A patient consultation group was also established. These activities received widespread attention from the news media in China and will become regular “International Clinical Trials Day” events to annually promote patient engagement. They aim to encourage more patients to actively participate in and contribute to the development of new medicines in China.

China’s huge population and large number of patients makes patient enrollment a major focus of sponsors and CROs in China. The growing role of informatic technology is already leading to technical improvement in accurate analysis and rapid identification of specific target patient populations. Pharmaceutical companies, CROs, and clinical study institutions are collaborating closely to promote patient engagement by increasing their awareness of clinical trials and accelerate the development of investigational drugs into clinical use, with the aim to improve the health and well-being of patients.

This article draws from the discussions at the DIA China Annual Meeting session Patient Engagement in Clinical Development hosted by Li Shuting (Jimin Cancer Hospital, Anhui Medical University) and featuring Song Kun (Pharmaron), Fan Xingfang (Bayer), and He Man (Taimei Technology).