Challenges of Investigator-initiated Clinical Trials to Support the New Drug Development
A large number of investigator-initiated clinical trials (IIT) were conducted in China, some of them should play an important supporting role in new drug development. Due to the large number, small scale and uneven quality of IIT in China, especially a big gap between the IIT and industry-sponsored...
| Main Authors: | , |
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| Format: | Article |
| Language: | zho |
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Chinese Anti-Cancer Association; Chinese Antituberculosis Association
2022-07-01
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| Series: | Chinese Journal of Lung Cancer |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.3779/j.issn.1009-3419.2022.102.31 |
| _version_ | 1811312805330026496 |
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| author | Hua BAI Shuyang ZHANG |
| author_facet | Hua BAI Shuyang ZHANG |
| author_sort | Hua BAI |
| collection | DOAJ |
| description | A large number of investigator-initiated clinical trials (IIT) were conducted in China, some of them should play an important supporting role in new drug development. Due to the large number, small scale and uneven quality of IIT in China, especially a big gap between the IIT and industry-sponsored trials in terms of protocol design, quality management and ethical review, many IIT can’t be used to support the new drug development. Therefore, it is necessary for regulatory authorities, sponsors, research institutions, ethics committees and researchers to improve their understanding of the role of IIT. In order to support the new drug development with high-quality IIT, formulating supervising system, establishing an effective quality management system, enhancing the training of researchers and improving the ability of ethical review should be implemented effectively. |
| first_indexed | 2024-04-13T10:43:05Z |
| format | Article |
| id | doaj.art-ea0e8f39145e4f1890c06bed7cdcd941 |
| institution | Directory Open Access Journal |
| issn | 1009-3419 1999-6187 |
| language | zho |
| last_indexed | 2024-04-13T10:43:05Z |
| publishDate | 2022-07-01 |
| publisher | Chinese Anti-Cancer Association; Chinese Antituberculosis Association |
| record_format | Article |
| series | Chinese Journal of Lung Cancer |
| spelling | doaj.art-ea0e8f39145e4f1890c06bed7cdcd9412022-12-22T02:49:53ZzhoChinese Anti-Cancer Association; Chinese Antituberculosis AssociationChinese Journal of Lung Cancer1009-34191999-61872022-07-0125751151610.3779/j.issn.1009-3419.2022.102.31Challenges of Investigator-initiated Clinical Trials to Support
the New Drug DevelopmentHua BAI0Shuyang ZHANG1Department of Scientific Research, Peking Union Medical College Hospital,
Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, ChinaDepartment of Cardiology, Peking Union Medical College Hospital,
Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, ChinaA large number of investigator-initiated clinical trials (IIT) were conducted in China, some of them should play an important supporting role in new drug development. Due to the large number, small scale and uneven quality of IIT in China, especially a big gap between the IIT and industry-sponsored trials in terms of protocol design, quality management and ethical review, many IIT can’t be used to support the new drug development. Therefore, it is necessary for regulatory authorities, sponsors, research institutions, ethics committees and researchers to improve their understanding of the role of IIT. In order to support the new drug development with high-quality IIT, formulating supervising system, establishing an effective quality management system, enhancing the training of researchers and improving the ability of ethical review should be implemented effectively.http://dx.doi.org/10.3779/j.issn.1009-3419.2022.102.31investigator-initiated clinical trialsnew drug developmentquality managementethical review |
| spellingShingle | Hua BAI Shuyang ZHANG Challenges of Investigator-initiated Clinical Trials to Support the New Drug Development Chinese Journal of Lung Cancer investigator-initiated clinical trials new drug development quality management ethical review |
| title | Challenges of Investigator-initiated Clinical Trials to Support
the New Drug Development |
| title_full | Challenges of Investigator-initiated Clinical Trials to Support
the New Drug Development |
| title_fullStr | Challenges of Investigator-initiated Clinical Trials to Support
the New Drug Development |
| title_full_unstemmed | Challenges of Investigator-initiated Clinical Trials to Support
the New Drug Development |
| title_short | Challenges of Investigator-initiated Clinical Trials to Support
the New Drug Development |
| title_sort | challenges of investigator initiated clinical trials to support
the new drug development |
| topic | investigator-initiated clinical trials new drug development quality management ethical review |
| url | http://dx.doi.org/10.3779/j.issn.1009-3419.2022.102.31 |
| work_keys_str_mv | AT huabai challengesofinvestigatorinitiatedclinicaltrialstosupportthenewdrugdevelopment AT shuyangzhang challengesofinvestigatorinitiatedclinicaltrialstosupportthenewdrugdevelopment |