Recruiting in China

Based on information gathered from several sources, it appears that clinical trial subjects in China are recruited in a limited number of ways, starting with heavy reliance on the investigator to tell appropriate patients about the study, followed by the use of posters and fliers in waiting rooms at accredited clinical trial sites.

Hospitals in the major cities, such as Beijing, Shanghai, Ghangzhou, Chongqing, and Nanjing, tend to be very large by Western standards, many with more than 1,000 beds, reflecting the centralized nature of healthcare delivery in China. As a result, doctors in those institutions are extremely busy, seeing as many as 50 patients most mornings.

Yet, while working at that harried pace, some doctors, especially those seeking to increase their clinical trial workload, remember to discuss clinical trials with patients. Yue Wei, vice president and medical director of Beijing MedSept Consulting Co., a CRO, says, “Doctors generally discuss the opportunity to participate with patients. That is the common way.”

Stefan Astrom, Ph.D., CEO of Astrom Research International, adds, “[Doctors] recruit patients from their regular patient pool. There is an abundance of patients and it's very attractive for them to participate in trials as they may receive new treatment, extra patient care and free medication.” In addition, patients generally do not see the same physician each time they visit a clinic, so the promise of seeing the same physician over the course of a clinical trial may spur interest...

Posters in the waiting rooms may make patients aware of ongoing trials but, according to Shanghai Pharma Engine, a Chinese CRO, patients rarely initiate discussions about them and generally look to the doctor to start this type of conversation.

Notification by physicians and posters may be the key modalities used to recruit subjects, but evidence suggests that other tools are used, as well, but to a lesser degree. A recent article referred to the use of newspapers to advertise about clinical trials.

Representatives of Union Clinical Research Services, Ltd., a Beijing-based company handling clinical trial management at Peking Union Medical College Hospital, explained to a 2005 U.S. delegation (see next section) that various types of electronic media, namely television and radio, are used. The general sense, however, is that electronic media is rarely used.

Sandy Matzek-Cole, one of the delegates, explains, “It’s not clear how frequently these modalities are used, and their use seems to be random rather than as part of an organized recruitment campaign.” Dr. Wei of Beijing MedSept adds, “A few use websites, but ads hardly ever appeared in the media. It’s mostly print-style posters.”

The limited advertising in China seems to be done in accordance with GCP Guidelines, whereby written approval for subject recruitment material is required by an independent ethics committee (IEC). Lisa Sun, clinical process manager for AstraZeneca Pharmaceutical Co. in Shanghai, says IEC approval for patient recruitment advertisements is routine in China. Furthermore, she explains that the names of the sponsor and the product cannot appear in the ads, “only the indication and/or target group as well as the contact name of the hospital or institute.”

Is compensation to study volunteers allowed in China?

GCP Guidelines allow for compensation of study volunteers, provided this information appears in the informed consent document, which has the written approval of the appropriate institutional review board (IRB) or ethics committee (ICH-GCP Sec. 4.8 and Guideline 7 of CIOMS). So, technically speaking, compensation is permitted in China.

In practice, however, there appears to be conflicting opinion on whether compensation is permitted. Some believe that compensation is provided to subjects participating in Phase I studies, but not in subsequent phases. Dr. Astrom says, “Healthy volunteers in Phase I studies are compensated according to international practices. Patients in Phase II, III and IV studies are never compensated, except occasionally for travel costs.”

Similarly, representatives of the Peking Union Medical College mentioned to the People-to-People delegation that generally, patients are not compensated for participation.

By contrast, James Fan, M.D., of Protech Pharmaservices Corp., a CRO, says, “According to No. 43 items of GCP issued by SFDA on 2003-09-01, the sponsor must pay compensation and insurance to patients or volunteers.”

In addition, guidance for medical device studies found in “Provisions for Clinical Trials of Medical Devices,” Chapter 2, specifically states that compensation for study volunteers is permitted, encouraged even, and that information about compensation is to be presented during the informed consent process.

Excerpted from Anderson's book International Patient Recruitment Regulatory Guidelines, Customs and Practices.