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In 1996, Good Clinical Practice (GCP), or ICH-GCP, has been formulated to provide guidelines for clinical research worldwide. GCP declares Quality assurance, Quality control, Monitor, Audit and Inspections. Which suggest that quality control is only one aspect of the quality assurance system, refers to the specific operation technology and implementation behave to meet a certain quality requirement of clinical trials, is a continuous process throughout the clinical trials to find problems, seek reasons and solutions and ultimately solve problems.
Specifically, GCP has stipulated the following requirements for the quality assurance of the following contents:
The preparation and necessary conditions before the test.
The contents of the rights and interests of the subjects in the trial.
The design, approval and modification of the test plan.
The responsibilities of the researcher, the applicant and the inspector in the experiment.
The requirements for data management and statistical analysis of the test.
The management of experimental drugs.
The establishment and implementation of test quality control and quality assurance system.
The core idea of GCP is to prevent and discover possible or already irregular problems in clinical trials to ensure the quality of clinical trials through a series of quality assurance and quality control activities. Quality assurance activities can benefit bidders in terms of time and funding. In order to achieve maximum benefits, quality assurance activities should be initiated in the early stages of new drug development, i.e. before clinical trials, until the conclusion of clinical trials.
Blind, randomized and well-controlled studies constitute the essence of modern clinical trials and solve the basic methodological problems of drug clinical trials. In the process of solving the contradictions such as test deviation, evaluation of test results, protection of subjects’ rights and interests, and insufficient test samples, the discipline system of drug clinical trials has been gradually constructed. It is the continuous improvement of this research system that has gradually transformed clinical trials into a highly efficient method, allowing about 90% of the tested drugs to be terminated or rejected for various reasons in order to ensure the quality of the drugs on the market as much as possible.
Clinical trials are generally divided into I, II, III and IV phases. There is an organic connection between the periods, rather than the four stages of division and isolation. Each phase of clinical trials should be properly planned, programmed and evaluated to ensure the scientificity of the trials and objectively evaluate the safety and effectiveness of the drugs.
Phase I clinical trials aim to test the dosage and safety of the drug, and specifically acquire the reasonable dose, the adverse reactions, and the metabolic pathway. Because phase I clinical trials are often the first human trials, monitoring toxicity or adverse reactions is very important.
Phase II clinical trials aim to study the effectiveness of drugs for a specific indication within the safe dose range defined by phase I, and the short-term adverse reactions and risks. Phase II clinical trials also include the further establishment of the maximum and minimum effective dose ranges, and the relationship between the therapeutic plasma concentrations and pharmacodynamic parameters, i.e. the relationship between drug metabolism and pharmacodynamics.
Phase III clinical trial is a key test for drug research and development. It is the basis for drug approval. Phase III clinical trials can only begin when satisfactory safety and efficacy results are obtained in both Phase I and Phase II trials. Phase III clinical trials are designed to further study the efficacy, long-term safety, and benefit/risk ratio of drugs.
Phase IV clinical trial is a clinical study conducted after the approval of the drug to explore the indications for new drug treatment, further evaluate the safety of new drugs or to prepare strategies for new drug marketing. Such clinical trials mainly include the following categories: supplementary clinical trials required by the Drug Administration when it makes conditional approval of new drug applications; long-term safety clinical studies required by the Drug Administration; drug clinical studies comparing efficacy with marketed drugs; clinical trials designed to familiarize doctors with or understand new drugs; a study of pharmacoeconomics or epidemiological methods.
In clinical trials, it is impossible to completely avoid quality problems, but we can maximize the avoidance of quality problems. This requires us to seriously discover the problems in the quality management of clinical trials, analyze the factors affecting the quality management, and use relevant methods to fundamentally solve the problems in the quality management of clinical trials, thereby improving the overall level of clinical trials.
The aim of quality control is to ensure the safety of drug clinical trial, and protect the rights and interests of the subjects to the fullest extent. High-quality clinical trials are based on standardized management and strict quality control. To ensure the drug safety, quality control for drug safety in all aspects of clinical trial is needed to ensure the scientificity and authenticity.
International Conference on Harmonization Tripartite Guideline for Good Clinical Practice
Joubert, P. H., & Rogers, S. M. (2015). ‘International Conference on Harmonization (ICH) and Other Guidelines.’ Strategic Scientific and Medical Writing. pp 85-89.
Moore SW. (2003) ‘An overview of drug development in the United States and current challenges.’[J]. SouthMed J, 96: 1244-1255.
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