The development and challenges of Investigator-Initiated Trials (IITs) in China
Abstract Investigator-Initiated Trials (IITs) have seen substantial growth in China, particularly in drug and medical device research. IITs are initiated by investigators addressing clinical needs without focus on product registration or marketing, thereby offering flexibility for advancing clinical...
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| Format: | Article |
| Language: | English |
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Springer
2024-12-01
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| Series: | Holistic Integrative Oncology |
| Online Access: | https://doi.org/10.1007/s44178-024-00123-7 |
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| _version_ | 1850169421139542016 |
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| author | Minghuang Hong Zhao Yan |
| author_facet | Minghuang Hong Zhao Yan |
| author_sort | Minghuang Hong |
| collection | DOAJ |
| description | Abstract Investigator-Initiated Trials (IITs) have seen substantial growth in China, particularly in drug and medical device research. IITs are initiated by investigators addressing clinical needs without focus on product registration or marketing, thereby offering flexibility for advancing clinical practices. Despite their potential, IITs in China face challenges, including regulatory ambiguities, funding limitations, quality control issues, and inconsistencies in ethical review processes. This paper examines the current IIT landscape, identifies major obstacles, and proposes solutions, including regulatory reforms, funding increases, ethical review standardization, and international collaboration, to enhance IITs' effectiveness and impact on Chinese clinical research. |
| format | Article |
| id | doaj-art-27befbcc67cc4b93a47dca7eec32c178 |
| institution | OA Journals |
| issn | 2731-4529 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Springer |
| record_format | Article |
| series | Holistic Integrative Oncology |
| spelling | doaj-art-27befbcc67cc4b93a47dca7eec32c1782025-08-20T02:20:44ZengSpringerHolistic Integrative Oncology2731-45292024-12-01311410.1007/s44178-024-00123-7The development and challenges of Investigator-Initiated Trials (IITs) in ChinaMinghuang Hong0Zhao Yan1Department of Clinical Research, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer CenterDepartment of Continuing Education and Technology Services, China Anti-Cancer AssociationAbstract Investigator-Initiated Trials (IITs) have seen substantial growth in China, particularly in drug and medical device research. IITs are initiated by investigators addressing clinical needs without focus on product registration or marketing, thereby offering flexibility for advancing clinical practices. Despite their potential, IITs in China face challenges, including regulatory ambiguities, funding limitations, quality control issues, and inconsistencies in ethical review processes. This paper examines the current IIT landscape, identifies major obstacles, and proposes solutions, including regulatory reforms, funding increases, ethical review standardization, and international collaboration, to enhance IITs' effectiveness and impact on Chinese clinical research.https://doi.org/10.1007/s44178-024-00123-7 |
| spellingShingle | Minghuang Hong Zhao Yan The development and challenges of Investigator-Initiated Trials (IITs) in China Holistic Integrative Oncology |
| title | The development and challenges of Investigator-Initiated Trials (IITs) in China |
| title_full | The development and challenges of Investigator-Initiated Trials (IITs) in China |
| title_fullStr | The development and challenges of Investigator-Initiated Trials (IITs) in China |
| title_full_unstemmed | The development and challenges of Investigator-Initiated Trials (IITs) in China |
| title_short | The development and challenges of Investigator-Initiated Trials (IITs) in China |
| title_sort | development and challenges of investigator initiated trials iits in china |
| url | https://doi.org/10.1007/s44178-024-00123-7 |
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