The process of obtaining approval for a new medication takes years. Clinical trials are one of the most important steps in the approval process.
A clinical trial is a series of research studies in which people volunteer to receive a treatment (such as a drug) and be observed for its effects-both in terms of its safety and its effectiveness.
CSL conducts clinical trials in accordance with the current Guideline for Good Clinical Practice (GCP) of the International Conference on Harmonisation (ICH). GCP is an international ethical and scientific quality standard for designing, conducting and reporting studies that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of study subjects are protected and that the clinical trial data are credible. Compliance with this standard also ensures that CSL conducts clinical trials consistent with the principles that have originated in the Declaration of Helsinki.
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Following a positive outcome in preclinical testing, the sponsoring organisation (usually a drug manufacturer) will seek approval to conduct clinical trials. Once approval has been granted, the sponsor will usually complete three phases of clinical testing in order for the applicable regulatory authority to approve the new treatment. An optional fourth phase typically follows approval.
|| ||For each phase of a clinical trial, the sponsor collaborates with physicians to conduct the clinical trial, prepares a plan (or protocol) that describes the clinical trial, and submits detailed paperwork to the applicable regulatory authority and independent review board to obtain approval to conduct the trial.|
-The process of testing an investigational drug on a small number of subjects to establish that it is safe for use in humans.
Phase II-The process of testing an investigational drug on a small number of subjects to show it is generally safe and effective in treating or preventing a specific condition or illness.
Phase III-The process of testing an investigational drug on a larger population of subjects to show that it is safe and effective in treating or preventing a specific condition or illness.
Phase IV-The process of testing an approved drug in order to determine additional information.