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Clinical Trial

Traditional Korean medicine center clinical trials leading to the era of the 21st century, traditional Korean medicine

An Overview

Introduction of Clinical Trial

Clinical trials refer to experimental research on human participants, the purpose of which is to evaluate the efficacy or safety of drugs or medical devices. The objective and methodology of the clinical trials should be reasonably scientific and ethical, since the experimental drugs or procedures are administered on healthy as well as unwell individuals. That is why clinical trials should follow, as per the Declaration of Helsinki, the ‘Good Clinical Practice’ guidelines issued by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Considering the risks involved, clinical trials should be able to justify the expected benefits to the participants as well as society. The rights, safety, and welfare of the participants are of utmost importance when designing and conducting clinical trials.

Procedure of Clinical Trial

  • Request of a clinical trial by sponsors, investigators, or any relevant parties
  • Feasibility assessment
  • Selection of primary investigator and offer of an estimate
  • Contract
  • Conduct of the clinical trial
  • Results and report

Development and Support for Clinical Trials of Drugs or Medical Devices in Korean Medicine

The Korean Medicine Clinical Trial Center (K-CTC) in Kyung Hee University Korean Medicine Hospital designs and conducts clinical trials on drugs and medical devices developed based on Korean Medicine, in order to evaluate their efficacy and safety. At K-CTC, clinical effectiveness of herbal medicine and medical devices can be tested along with pharmacodynamics or pharmacology. K-CTC tries to show the effectiveness and safety of the aforementioned terms, investigate the interactions of herbal medicine and western drugs, and develop the scientific tools necessary to diagnose a disease and its severity, through Korean medicine. K-CTC is striving for the scientification and standardization of Korean Medicine.

Performance

  • Recommendation of Primary Investigator
  • Development of Protocols
  • Development of paper or electronic CRFs
  • Consultation or Support on Regulations and Guidelines for Clinical Trials
  • Development of Investigator’s Products / Placebo Drugs
  • Conduct of Clinical Trials