Pharmaceutical News
Protect subjects’ rights in clinical trials

Reported by Chen Xuan-Yu from Taipei


Patients with chronic diseases quite often find themselves in a dilemma when being approached by their doctors who offer them an invitation of new drug clinical trials.  They worry that their refusal may disappoint doctors and hence make themselves unpopular or even lead to treatment discrimination.  According to experts, it is essential for patients to be fully informed of the information about the investigational medicinal products and potential risks before they sign up for any clinical trials.  Patients should also make sure that they don’t have any contraindications to the trial products.


The NTUH held an educational event to advocate subject’s rights in clinical trials.  Hsu Ming-Nung, Deputy Minister of the MOHW, Cheng An-Li, Deputy Superintendent of the NTUH, and Chen Chien-Wei, Deputy Director of the Department of Medical Research of the NTUH, all attended this event.


Chen An-Li, Deputy Superintendent of the NTUH, expressed that the NTUH established the Clinical Trial Center in 2001 in order to promote the research and application of investigational medicinal products during the stage of clinical trials.   Doctors may invite patients to participate in clinical trials after evaluating the safety issues.  However, patients are entitled to withdraw from clinical trials at any time during the trial without worrying about being discriminated by doctors afterwards.


Chen Chien-Wei, Deputy Director of the Department of Medical Research of the NTUH, expressed that there are about 200 clinical trial projects in the NTUH every year, covering new drugs, vaccines and medical devices.  Doctors have the obligation to explain in details to patients intending to participate so that patients can fully understand the potential risk.


There is no need for patients to rush into decisions.  They can hold on to the consent form for a period of time and read it thoroughly with their family.


Many patients worry that they might be blacklisted by the doctors once they refuse to take part in a clinical trial.  Chen Chien-Wei explained that the consent form gives patients the right to withdraw from a trial at any time during the trial without any string attached.  The consent form also states that the withdrawal will not lead to any unfavourable treatments afterwards.  However, if patients feel their rights have been affected, they can file a complaint to the NTHU at any time. 



【2015-10-15/ China Times】