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Addressing the knowledge of subjects’ protection by us 【發布日期:2019-12-11】 發布單位:藥品組

The goal of new drug development is to develop safe and effective drugs and then to promote public health. New drugs must conduct systematic, rigorous studies on the human body, commonly referred to as clinical trials.

Consequently, clinical trials are an essential part of the new drug development, investigation drugs are still being studied for therapeutic efficacy and safety, even there exists higher unknown risks, and its final efficacy has also to be determined.

The Taiwan Food and Drug Administration (TFDA) had upheld the principle of protecting the subject and conducted 18 promotional campaigns around Taiwan since 2016. Hope to enhance the knowledges of the participants.

Consider the unknown risks of new drug trials and protect subjects, TFDA recommends those participants who are willing to attend the clinical trial, have to understand the following 7 matters: What is the purpose of the clinical trial? What happens during the clinical trial process? What are the possible adverse reactions? What are the inclusion criteria for the participants? What are the benefits and expected outcomes of the clinical trial? Does the participant need to pay for joining the clinical trial? Is there any alternative treatment available? What are the rights of the participants? What are the obligations of participants? Please understand the information before participating and protect your rights.

When conducting a clinical trial, the clinical team complies with the Declaration of Helsinki (autonomy, beneficence, and justice) as well as obeys the Medical Care Act and Regulations for Good Clinical Practice. TFDA and Institutional Review Boards will carefully review clinical trial protocols and reports in order to protect participants together.

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