GOOD CLINICAL PRACTICE
Good Clinical Practice (GCP) is an international quality standard for conducting clinical trials that is provided by International Conference on Harmonization of technical requirements (ICH) for registration of pharmaceuticals for human use.
GCP guideline includes protection of human right for the subject and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. All clinical trials conducted in HKCCR adhere to ICH-GCP. The study protocols are submitted to a local ethics committee and the Hong Kong Department of Health for approval.
Studies are subjected to audits by the Food and Drug Administration of the USA (FDA) and the European Medicine Agency (EMA). We have passed all previous audits.
Q1. What are clinical trials?
Clinical trials are conducted to test and develop new drugs. In clinical trials, the effectiveness and safety of new drugs are being studied in details.
Q2. Why should I participate in a clinical trials?
Participants in clinical trials can play an active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Q3. Who can participate in a clinical trial?
Every clinical trial has particular entry criteria such as age, gender, medical history. The criteria are used to identify appropriate participants and keep them safe. Before joining a clinical trial, a participant must be examined and qualified for the study.
Q4. What are the procedures of a clinical trial?
The clinical trial team includes doctors, nurses and professional research and technical staff. They provide comprehensive assessment to the participants, give specific instructions, monitor the participants’ health carefully during the trial, and provide necessary continuesd care after the trial is completed.
Q5. What should I consider before participating in a trial?
You should know as much as possible about the clinical trial and feel comfortable by asking the members of the research team questions about the trial.