The Sino-Japan Friendship Hospital in Beijing created history in mid August, becoming the first hospital in China to enlist volunteers for clinical trials. The medications on trial are Gout Medication, designed to cure gout, and YH-16, designed to cure lung cancer.
Developed countries have been conducting such trials for many years now, where members of the public have contributed to the development of specialised medicine. The medical establishments have been able to assess the potential of new medications by observing the effects on volunteer patients. In China the situation is very different, where legal and moral standards have prevented the medical community?s pursuit of this experimental approach.
Notices requesting volunteers at the China-Japan Friendship Hospital have bemused Chinese patients. Despite the support and enthusiasm of medical staff at the hospital, few candidates have volunteered for the trials. The problem is one of perception. The medical community take a pioneering approach, while the public view the trials as experimental tests.
Far from being experimental, the process is a rather stringent one. Suitable volunteers must sign an agreement and undergo an assessment by medical specialists before receiving either Gout Medication or YH-16. Of the volunteers who have actually come forward, only a small number have been found to be suitable for the trial.
Doctors involved with the trials say there are no risks for the volunteers, however this confidence has done little to allay the fear and apprehension felt by the public. Ignorance and misconception has prevented many potential candidates from volunteering. Patients are just not willing to take part in what they consider to be untried research. The majority of potential candidates mistakenly believe that the medication on trial is uncertified.
Contrary to popular belief, the experimental nature of the medicine is a minor component of the trial. Clinical trials are actually designed to illustrate the remedial qualities of new medication. Trials also aim to determine appropriate dosage and assess potentially harmful side effects. Famous tumour specialist, Doctor Xu Guangwei, states ?The only risk for patients taking new medicine is the potential for harmful side effects. Patients will not be charged for the treatment of these side effects.?
In an effort to dispel ignorance, Doctor Xu explains the importance of a safe and comprehensive program. In order to reach the clinical trial stage, new medication must pass a compulsory three-stage program. Firstly, the medication must satisfy a medical researcher in 18 different data trials. Secondly, the State Drug Administration must grant permission for clinical trials to commence. Lastly, the medical researcher must satisfy the queries of an expert panel of specialists.
Success in these three stages does not necessarily guarantee that a new drug will be clinically trialled.
The trial can only take place in hospital programs that have been sanctioned by the central government. All doctors involved in the programs must be qualified specialists.
Doctors supervising the trials are required by state regulation to clearly explain to volunteers the key elements of the trial. All candidates must be informed of the characteristics of the medicine being tested, the aim of the clinical trial, the potential side effects and the rights of the volunteer. Trials cannot commence until volunteers have understood this information and voluntarily accepted the conditions explained to them. Once the clinical trials commence, all volunteers have the right to leave the trial process at any time, under any condition.
(china.org.cn by Wu Nanlan, September 17, 2002)
