From Bench to Bedside: A Review of Clinical Trials in Drug Discovery and Development

Fuente: arXiv
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Main Authors: Wang, Tianyang, Liu, Ming, Peng, Benji, Song, Xinyuan, Zhang, Charles, Sun, Xintian, Niu, Qian, Liu, Junyu, Chen, Silin, Chen, Keyu, Li, Ming, Feng, Pohsun, Bi, Ziqian, Wang, Yunze, Zhang, Yichao, Fei, Cheng, Yan, Lawrence KQ, Qin, Ziyuan, Bao, Riyang, Jiang, Zekun
Format: Preprint
Published: 2024
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author Wang, Tianyang
Liu, Ming
Peng, Benji
Song, Xinyuan
Zhang, Charles
Sun, Xintian
Niu, Qian
Liu, Junyu
Chen, Silin
Chen, Keyu
Li, Ming
Feng, Pohsun
Bi, Ziqian
Wang, Yunze
Zhang, Yichao
Fei, Cheng
Yan, Lawrence KQ
Qin, Ziyuan
Bao, Riyang
Jiang, Zekun
author_facet Wang, Tianyang
Liu, Ming
Peng, Benji
Song, Xinyuan
Zhang, Charles
Sun, Xintian
Niu, Qian
Liu, Junyu
Chen, Silin
Chen, Keyu
Li, Ming
Feng, Pohsun
Bi, Ziqian
Wang, Yunze
Zhang, Yichao
Fei, Cheng
Yan, Lawrence KQ
Qin, Ziyuan
Bao, Riyang
Jiang, Zekun
contents Clinical trials are an indispensable part of the drug development process, bridging the gap between basic research and clinical application. During the development of new drugs, clinical trials are used not only to evaluate the safety and efficacy of the drug but also to explore its dosage, treatment regimens, and potential side effects. This review discusses the various stages of clinical trials, including Phase I (safety assessment), Phase II (preliminary efficacy evaluation), Phase III (large-scale validation), and Phase IV (post-marketing surveillance), highlighting the characteristics of each phase and their interrelationships. Additionally, the paper addresses the major challenges encountered in clinical trials, such as ethical issues, subject recruitment difficulties, diversity and representativeness concerns, and proposes strategies for overcoming these challenges. With the advancement of technology, innovative technologies such as artificial intelligence, big data, and digitalization are gradually transforming clinical trial design and implementation, improving trial efficiency and data quality. The article also looks forward to the future of clinical trials, particularly the impact of emerging therapies such as gene therapy and immunotherapy on trial design, as well as the importance of regulatory reforms and global collaboration. In conclusion, the core role of clinical trials in drug development will continue to drive the progress of innovative drug development and clinical treatment.
format Preprint
id arxiv_https___arxiv_org_abs_2412_09378
institution arXiv
publishDate 2024
record_format arxiv
spellingShingle From Bench to Bedside: A Review of Clinical Trials in Drug Discovery and Development
Wang, Tianyang
Liu, Ming
Peng, Benji
Song, Xinyuan
Zhang, Charles
Sun, Xintian
Niu, Qian
Liu, Junyu
Chen, Silin
Chen, Keyu
Li, Ming
Feng, Pohsun
Bi, Ziqian
Wang, Yunze
Zhang, Yichao
Fei, Cheng
Yan, Lawrence KQ
Qin, Ziyuan
Bao, Riyang
Jiang, Zekun
Computers and Society
Computation and Language
Clinical trials are an indispensable part of the drug development process, bridging the gap between basic research and clinical application. During the development of new drugs, clinical trials are used not only to evaluate the safety and efficacy of the drug but also to explore its dosage, treatment regimens, and potential side effects. This review discusses the various stages of clinical trials, including Phase I (safety assessment), Phase II (preliminary efficacy evaluation), Phase III (large-scale validation), and Phase IV (post-marketing surveillance), highlighting the characteristics of each phase and their interrelationships. Additionally, the paper addresses the major challenges encountered in clinical trials, such as ethical issues, subject recruitment difficulties, diversity and representativeness concerns, and proposes strategies for overcoming these challenges. With the advancement of technology, innovative technologies such as artificial intelligence, big data, and digitalization are gradually transforming clinical trial design and implementation, improving trial efficiency and data quality. The article also looks forward to the future of clinical trials, particularly the impact of emerging therapies such as gene therapy and immunotherapy on trial design, as well as the importance of regulatory reforms and global collaboration. In conclusion, the core role of clinical trials in drug development will continue to drive the progress of innovative drug development and clinical treatment.
title From Bench to Bedside: A Review of Clinical Trials in Drug Discovery and Development
topic Computers and Society
Computation and Language
url https://arxiv.org/abs/2412.09378