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What is clinical trial?

A trial or research that is executed with human subjects for the purpose of verifying the stability and validity of an investigative drug, we confirm the corresponding drug’s pharmacokinetic, pharmacodynamic, pharmacologic, clinical effects and research abnormal reactions.


CENTRAL

Clinical Trial Center

Stages of clinical trial

  • 01


    Novel drug candidate substance development

    A procedure that compose and separate novel drug candidates from natural substances after setting drug discovery target. The chances of a successful new drug development from the procedure of screening a substance is about one in 1000~10000.

  • 02


    Preclinical Trial

    A procedure that estimate the efficacy and stability through animal testing before testing a newly developed drug in a human subject, it is mainly formed with manufacturing pharmacologic test, toxicity test, pharmacological test.

  • 03


    Phase 1 Clinical Trial

    An early clinical trial stage that examines the drug absorption, distribution, metabolizing, excretion and confirms the adverse effect, safety dose by initially medicating novel drug candidates to relatively limited human subjects(20~80 subjects) with the bases of pharmacological action datas from preclinical trials.

  • 04


    Phase 2 Clinical Trial

    A procedure that is proceed to verify the safety and validity of the new drug, it is usually sorted into two stages. One an early pilot study which confirms pharmaceutical efficacy, determination of optimum dose, method, and post – pivotal trial level. It is usually proceeded in a limited number of about 100~200 or more target patient that can be thoroughly examined, as for antibiotics that has various indications it is proceeded in much more target patients.

  • 05


    Phase 3 Clinical Trial

    It is proceed for additional valid informations or a firm collection of evidence about the indicant target diseases, after the validity of the new drug is established at a certain degree. Depending on the type of the trial, usually a long-term multi-center study is proceeded and the number of target patients vary with the characteristics of the drug. In general, the desirable number of target patients are when we can confirm the key side effects that occurs at one in a 1000 rate.

  • 06


    Phase 4 Clinical Trial

    As a clinical trial proceed after getting applications for marketing, is to inquire effectiveness on safety investigation, special pharmacological action investigation( pharmacological action research, morbidity rate of drug use, mortality by the purpose of a long-term large tracer study, further research for data supplementation drawn after phase 3 clinical trial, clinical trial with special target patients that hasn’t been reviewed at clinical trials before marketing applications, and search for new indications.

Clinical Trials Submission Process

  • 01Participant recruit notice

    - When a researcher or client needs a participant for clinical trials, they run a recruit notice/ad. We run a recruit notice at bulletin boards inside the hospital, clinical trial center’s internet message board, or if needed, a recruit ad on mass media(news paper, broadcasting).

  • 02Clinical trials application for participation

    - If you are willing to participate on clinical trials, apply by our website, telephone, or come visit the Clinical Trial Center directly.

  • 03Make an appointment for visit

    - After registering as a clinical trial participant, you get to choose a schedule to visit for the detailed information introduction of the clinical trial you’ve been registered.

  • 04Sign written agreement

    - A participant that are available for the clinical trial should visit the Clinical Trial Center on the reservation day, get introductions about the trial from the researcher or research nurse and sign written agreements that this participation was a spontaneous decision. You’ll receive detailed explanations of recommended necessaries about protection of the participant’s human rights such as: the purpose and procedure of the clinical trial, expected efficacy and effects, side effects and risks, (if you’re currently a patient) the existence of other therapeutic methods for the current disease, that you’ll not be disadvantaged because of disagreeing participation, the participant can whenever withdraw by one’s own will even after agreeing to participate in the trial, etc.

  • 05Preliminary inspection(screening)

    - Preliminary inspection is a necessary step that confirms the participant’s fitness in this clinical trial, the required time may vary but takes about 30 minutes average.

  • 06Participate on clinical trials

    - When judged adequate for the corresponding clinical trial, you can participate in the actual clinical trial. As the clinical trial is a research that is proceeded following the fixed plans, you may receive planned procedures and take investigative new medication by accurately following the introduction of the researcher. We may collect the participant’s blood or urine several times for the examination of safety and validity, pharmacokinetics of the subjected remedy or medicine. The total blood collection volume of these tests does not exceed the amount of blood that is collected in one time blood donation.

  • 07End of visit

    - If there aren’t significant reports during the clinical trial, the test participation ends after planned period. But on the contrary when significant reports occur, we may stop the participant’s test participation by depending of the researcher’s judgement or participant’s decision.