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The value the ICH Guidelines bring to the field of clinical research - Essay Example

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It is defined as research that needs the direct involvement of an individual or group of people. It can also involve the usage of materials from human beings,…
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The value the ICH Guidelines bring to the field of clinical research
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ICH Guidelines Clinical research is a sensitive area because it is research based on humans or things from human beings like samples. It is defined as research that needs the direct involvement of an individual or group of people. It can also involve the usage of materials from human beings, which include but limited to tissue samples and behavioral patterns. Therefore, it is paramount for authorities to set clear guidelines to ensure the research is done within ethical guidelines for the benefit of humankind. ICH Guidelines have helped in creating the benchmark for quality, safety, efficiency, and the involvement of other fields of study in the research.
The quality guidelines ensure maintenance of high quality in clinical research at all times. The guidelines provide harmonization procedures that are crucial for standardization of clinical research. The presence of standardization means it is easy to monitor factors that point to low quality. The quality guidelines provide the thresholds for testing and a relatively flexible approach to research that includes the use of pharmaceutical products (ICH, 2005). Quality guidelines ensure good manufacturing practices are implemented in the production of all pharmaceutical products.
ICH guidelines support clinical research by availing detailed safety guidelines that increases the chances of success and limits injuries (ICH, 2005). The guidelines aid in identifying or unearthing potential risks, which include carcinogenicity, reprotoxicity, and genotoxicity. Recently, there was a breakthrough in a non-clinical testing strategy that is used to assess the QT internal prolongation liability. It is a signification contribution to the field of clinical research. The carcinogenicity studies provide safety guidelines on the use of rodents, the importance of carcinogenicity pharmaceuticals, prices, and any relevant issues that affect the performance of the drug. Safety guidelines help in maximizing success and minimizing failure and losses. Safety is among the foundational issues in matters concerning clinical research.
Efficacy guidelines are all about conduct, design, safety and the reporting guidelines for clinical trials (ICH, 2005). They provide a benchmark that can be used to measure success or efficiency in the clinical research. The guidelines also touch on new drugs that have been made biotechnological procedures and the use of genomic techniques. These processes aid in the development of improved medicines. These guidelines have a huge impact on the safety of clinical trials. The use of inappropriate design or reporting procedures amounts to no success.
Multidisciplinary guidelines cover the significant topics that cannot be classified under efficacy, quality, or safety guidelines. Some of the topics covered under these guidelines include ICH medical terminology (MedDRA) and the Common Technical Document (CTD) (ICH, 2005). These guidelines play a significant role in the definition and classification of drugs during classical trials. A proper understanding of these factors has an impact on the success of the organization.
In conclusion, ICH guidelines are valuable to the field of clinical research. They provide a quality benchmark that can be used for evaluation. The resulting effect is quality improvement and innovation, which helps to boost clinical research. The guidelines provide direction for clinical research professionals who are involved in the engineering of medicine, clinical trials, or administration of trial drugs. ICH guidelines are at the center of clinical research.
References
ICH. (2005). ICH Guidelines. Retrieved from ICH: http://www.ich.org/products/guidelines.html Read More
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