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What are clinical trials?
>Clinical trials refer to systematic trials on human subjects (patients or healthy subjects) that are designed to investigate pharmacology, pharmacokinetics and pharmacodynamics of an investigational drug in order to determine the safety, tolerability as well as efficacy of an investigational drug.
Clinical trials generally consist of four phases:
Phase I studies are designed to examine safety, tolerability as well as pharmacokinetics and pharmacodynamics of an investigational drug. Phase I studies are also designed to uncover early evidences of clinical efficacy that warrant Phase II studies.
Phase II studies are designed to investigate the efficacy and safety of an investigational drug in patients with a specific or multiple disease indications that warrant Phase III studies.
Phase III studies are designed to examine the safety and efficacy of an investigational drug as compared to the standard-of-care treatment and are carried out as multicenter clinical trials. Phase III studies are critical for evaluating safety, efficacy and overall benefit-risk relationship of an investigational drug that are essential for the NDA application.
Phase IV studies are designed to examine the effectiveness and safety of a post-marketing drug in order to evaluate benefit-risk relationship in the general or special population.
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What are subjects?
>Subjects are patients and healthy volunteers in clinical trials who receive an investigational drug or a placebo.
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What eligibility do you need to participate in a clinical trial?
>Each clinical trial has inclusion and exclusion criteria including age and physical condition, etc. Subjects will be screened for eligibility including medical history, current and past medications, preliminary checkups and checkups designed for the clinical trials.
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Where can you get information about clinical trials?
>●Information for on-going clinical trials can be found on the following registries: Chinadrugtrials.org (http://www.chinadrugtrials.org.cn/index.html) and Clinicaltrials.gov (https://clinicaltrials.gov/ ).
●Information of ongoing clinical trials may be posted hospitals and clinics or referred by doctors.
●Information of ongoing clinical trials may be obtained through health talks at communities, hospitals, patient support groups as well as organizations and associations.
●Information of ongoing clinical trials may be found through app in WeChat.
