DISCOVER RESEARCH & DEVELOPMENT > CLINICAL TRIALS

What are clinical trials?

Clinical trials are research studies intended to answer scientific questions and find better ways to treat or prevent diseases. They are fundamental to the development of innovative biopharmaceutical products.

Clinical studies are conducted to determine the safety and efficacy of new treatment or medicine used by humans. Such studies require voluntary participants (both healthy volunteers and patients) who accept to be involved in trying new medicines or vaccines.

Generally, the tested drugs or investigational drugs can be either the drug has not yet been approved by international health authorities or the on-sale drug with improved formula to evaluate potential of this drug to other treatments.

 CLINICAL TRIAL

Various phases of clinical trials:

Clinical trials are usually consisted of four phases. Each phase is designed to answer specific research questions. They have to follow strict, pre-defined protocol to assure safe and accurate results.  The drug-development process will normally last throughout four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually gain the approval of the national regulatory authority for marketing. Thus, Phase IV are called “post-marketing” study.

Before the drug is tested on clinical trials, it must be evaluated in vitro and in a pre-clinical study by using animals

Nanogen clinical trials

At Nanogen, all clinical trials are run according to the Principles of Good Clinical Practice (GCP) of ICH (International conference o­n Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use) or GCP of WHO (World Health Organization). Additionally, they must be approved by National Regulatory authorities and Ethics Committees. These boards ensure that proposed trials are acceptable and all participants are fully aware of benefits and risks related to the trial. Healthcare professional, or investigators, who conduct the trials must take appropriate actions to protect patients from any potential harms.

During the phases of trials, Nanogen takes evaluation of the benefit-risk portfolio of new medicine. If the risks exceed patients’ benefits, Nanogen will adjust the protocol or halt the study for that medicine.

Furthermore, Nanogen has taken several important steps to ensure that information about clinical trial results reach the public in a timely and balanced manner.

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