{"title":"临床研究中如何处理样本量的探索和报告?","authors":"S. Dwivedi","doi":"10.58999/cijmr.v1i03.65","DOIUrl":null,"url":null,"abstract":"The minimum sample size required to answer a specific research question is unavoidable regardlessof study designs, more pertinent in case of randomized controlled trials. Sample size exploration isnot required in many situations, including a pilot study; it is simply decided as feasible or a rule ofthumb. However, in situations, including a conclusive study like the third and final phase of drugdevelopment, it becomes mandatory to ensure optimal power as well as level of confidence to thestudy. The present write-up aims to address various issues related to sample size considerations forclinical studies in a non-statistical language, focusing on making it easily understandable by medicalresearchers.","PeriodicalId":127536,"journal":{"name":"Central India Journal of Medical Research","volume":"19 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"How to Deal with Sample Size Exploration and its reporting in Clinical Research?\",\"authors\":\"S. Dwivedi\",\"doi\":\"10.58999/cijmr.v1i03.65\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The minimum sample size required to answer a specific research question is unavoidable regardlessof study designs, more pertinent in case of randomized controlled trials. Sample size exploration isnot required in many situations, including a pilot study; it is simply decided as feasible or a rule ofthumb. However, in situations, including a conclusive study like the third and final phase of drugdevelopment, it becomes mandatory to ensure optimal power as well as level of confidence to thestudy. The present write-up aims to address various issues related to sample size considerations forclinical studies in a non-statistical language, focusing on making it easily understandable by medicalresearchers.\",\"PeriodicalId\":127536,\"journal\":{\"name\":\"Central India Journal of Medical Research\",\"volume\":\"19 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-02-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Central India Journal of Medical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.58999/cijmr.v1i03.65\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Central India Journal of Medical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.58999/cijmr.v1i03.65","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
How to Deal with Sample Size Exploration and its reporting in Clinical Research?
The minimum sample size required to answer a specific research question is unavoidable regardlessof study designs, more pertinent in case of randomized controlled trials. Sample size exploration isnot required in many situations, including a pilot study; it is simply decided as feasible or a rule ofthumb. However, in situations, including a conclusive study like the third and final phase of drugdevelopment, it becomes mandatory to ensure optimal power as well as level of confidence to thestudy. The present write-up aims to address various issues related to sample size considerations forclinical studies in a non-statistical language, focusing on making it easily understandable by medicalresearchers.