{"title":"加速药物开发:缩短临床试验的管理和操作策略","authors":"","doi":"10.33140/ijcrt.08.03.08","DOIUrl":null,"url":null,"abstract":"This article explores various regulatory and operational strategies aimed at accelerating drug development by shortening clinical trials. The length of traditional clinical trials presents challenges in delivering timely therapies to patients, making it crucial to identify approaches that expedite the process without compromising safety or data integrity. The strategies discussed include adaptive trial designs, utilizing surrogate endpoints, leveraging real-world evidence, regulatory flexibility, streamlined protocols and procedures, and enhanced patient recruitment and enrollment. By implementing these strategies, researchers can make informed decisions, expedite data analysis, and enhance trial efficiency. The article emphasizes the importance of collaboration among stakeholders to advance the field of clinical trials and bring innovative therapies to patients more quickly","PeriodicalId":93106,"journal":{"name":"International journal of cancer research & therapy","volume":"77 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Accelerating Drug Development: Regulatory and Operational Strategies for Shortening Clinical Trials\",\"authors\":\"\",\"doi\":\"10.33140/ijcrt.08.03.08\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"This article explores various regulatory and operational strategies aimed at accelerating drug development by shortening clinical trials. The length of traditional clinical trials presents challenges in delivering timely therapies to patients, making it crucial to identify approaches that expedite the process without compromising safety or data integrity. The strategies discussed include adaptive trial designs, utilizing surrogate endpoints, leveraging real-world evidence, regulatory flexibility, streamlined protocols and procedures, and enhanced patient recruitment and enrollment. By implementing these strategies, researchers can make informed decisions, expedite data analysis, and enhance trial efficiency. The article emphasizes the importance of collaboration among stakeholders to advance the field of clinical trials and bring innovative therapies to patients more quickly\",\"PeriodicalId\":93106,\"journal\":{\"name\":\"International journal of cancer research & therapy\",\"volume\":\"77 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International journal of cancer research & therapy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.33140/ijcrt.08.03.08\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International journal of cancer research & therapy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.33140/ijcrt.08.03.08","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Accelerating Drug Development: Regulatory and Operational Strategies for Shortening Clinical Trials
This article explores various regulatory and operational strategies aimed at accelerating drug development by shortening clinical trials. The length of traditional clinical trials presents challenges in delivering timely therapies to patients, making it crucial to identify approaches that expedite the process without compromising safety or data integrity. The strategies discussed include adaptive trial designs, utilizing surrogate endpoints, leveraging real-world evidence, regulatory flexibility, streamlined protocols and procedures, and enhanced patient recruitment and enrollment. By implementing these strategies, researchers can make informed decisions, expedite data analysis, and enhance trial efficiency. The article emphasizes the importance of collaboration among stakeholders to advance the field of clinical trials and bring innovative therapies to patients more quickly