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I am curious about the procedure for pharmaceutical clinical trials.

Hello. As I have been studying matters related to new drug development, I have become curious about how the procedure for pharmaceutical clinical trials proceeds. I would like to know the overall process of what procedures a pharmaceutical clinical trial goes through. I would also be grateful if you could tell me whether a new drug can be approved and actually sold only after all of these procedures have been completed.

pharmaceutical clinical trials

Answer to Related Inquiry

Author: 김국일

A pharmaceutical clinical trial proceeds through the approval procedures of the Ministry of Food and Drug Safety and the Institutional Review Board (IRB), and it is structured so that whether a new drug is approved is determined through verification of its safety and efficacy.

First, the sponsor of the clinical trial prepares a clinical trial protocol and applies for approval to the Ministry of Food and Drug Safety and the Institutional Review Board (IRB) within the conducting institution.

The two bodies review the protocol in detail and then decide whether to approve it.

The sponsor then requests the principal investigator to conduct the pharmaceutical clinical trial in order to confirm the safety and efficacy of the candidate substance for the new drug.

The principal investigator fully explains the purpose and procedures of the clinical trial to the subjects, obtains their consent, and then conducts the trial in a scientific and ethical manner in accordance with the clinical trial protocol.

In addition, during the course of the pharmaceutical clinical trial, the Ministry of Food and Drug Safety may conduct fact-finding investigations of the trial-conducting institution, the sponsor, and the principal investigator, and ultimately it evaluates the safety and efficacy of the candidate substance to decide whether to approve the new drug, so that only approved pharmaceuticals can be sold.