Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to treat...Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to treatment.As an effective traditional Chinese medicine,the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.Objective:To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy.This statistical analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled trial.Methods:Our study is a multicenter,double-blind,randomized controlled clinical trial.This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula.To attenuate possible selection bias in the final report,we declared the overall trial design,outcome measures,subgroup analyses,and safety measures.Also,we described the data management and statistical analysis methods in detail.Conclusion:The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods.Further post-hoc analyses can be performed by referring to the SAP,and possible selection bias can be attenuated.展开更多
After preclinical research, the effectiveness and safety of new drugs are finally verified by human clinical trials. As an important tool for clinical trial design, implementation and analysis, statistics is becoming ...After preclinical research, the effectiveness and safety of new drugs are finally verified by human clinical trials. As an important tool for clinical trial design, implementation and analysis, statistics is becoming more and more important in innovative drug research and development. Based on the guiding principles of international and domestic regulators and industry consensus, this paper expounds the key issues that should be considered in the statistical analysis plan of confirmatory drug clinical trials.展开更多
Introduction:Letrozole showed higher ovulation and live birth rates than clomiphene in infertile women with polycystic ovary syndrome(PCOS).Berberine,a major active component of Chinese herbal medicine rhizomacoptidis...Introduction:Letrozole showed higher ovulation and live birth rates than clomiphene in infertile women with polycystic ovary syndrome(PCOS).Berberine,a major active component of Chinese herbal medicine rhizomacoptidis,has been used to improve insulin resistance to facilitate ovulation induction in women with PCOS,but there is no study reporting the live birth or its potential as a complementary treatment to letrozole.We aim to determine the efficacy of letrozole with or without berberine in achieving live births among 644 infertile women with PCOS in China's Mainland.Methods and analysis:This is a prospective,randomized,multicentre,double-blinded,controlled design.Infertile women with PCOS were randomized into three-arm,letrozole and berberine,letrozole and berberine placebo,letrozole placebo and berberine.Data and blood were collected at baseline,the third month and sixth month after treatment,or immediately were collected if subject was pregnant.Statisticians and clinical investigators were blinded to treatment allocation and treatment related study results until the central database was locked for final data extraction and analysis determined.The statistical analysis plan described basic analysis principles,methods commonly encountered in data analysis issues,and the specific statistical procedures for analyzing the primary,secondary,and safety outcomes.Ethics and dissemination:The study was approved by the ethics committee of the First Affiliated Hospital,Heilongjiang University of Chinese Medicine.The study findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration:Chinese Clinical Trial Registry:Chi CTR-TRC-09000376.Clinical Trials.gov identifier:NCT01116167.展开更多
基金funded by the Key R&D project of the Ministry of Science and Technology,China(2017YFC1700604).
文摘Background:Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions,including nausea,vomiting,and diarrhea,which make it challenging for them to adhere to treatment.As an effective traditional Chinese medicine,the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy.Objective:To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy.This statistical analysis plan(SAP)is intended to enhance the transparency and research quality of our randomized controlled trial.Methods:Our study is a multicenter,double-blind,randomized controlled clinical trial.This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula.To attenuate possible selection bias in the final report,we declared the overall trial design,outcome measures,subgroup analyses,and safety measures.Also,we described the data management and statistical analysis methods in detail.Conclusion:The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods.Further post-hoc analyses can be performed by referring to the SAP,and possible selection bias can be attenuated.
文摘After preclinical research, the effectiveness and safety of new drugs are finally verified by human clinical trials. As an important tool for clinical trial design, implementation and analysis, statistics is becoming more and more important in innovative drug research and development. Based on the guiding principles of international and domestic regulators and industry consensus, this paper expounds the key issues that should be considered in the statistical analysis plan of confirmatory drug clinical trials.
基金Funded by the National Public Welfare Projects for Chinese Medicine(200807021)of Chinathe "11th–Five" Supportive Program for Science and Technology of China(2007BAI20B015)+1 种基金the Heilongjiang Province Foundation for Outstanding Youths(JC200804)the Intervention for Polycystic Ovary Syndrome Based on Traditional Chinese Medicine Theory-‘Tian Gui Shi Xu’(2011TD006)
文摘Introduction:Letrozole showed higher ovulation and live birth rates than clomiphene in infertile women with polycystic ovary syndrome(PCOS).Berberine,a major active component of Chinese herbal medicine rhizomacoptidis,has been used to improve insulin resistance to facilitate ovulation induction in women with PCOS,but there is no study reporting the live birth or its potential as a complementary treatment to letrozole.We aim to determine the efficacy of letrozole with or without berberine in achieving live births among 644 infertile women with PCOS in China's Mainland.Methods and analysis:This is a prospective,randomized,multicentre,double-blinded,controlled design.Infertile women with PCOS were randomized into three-arm,letrozole and berberine,letrozole and berberine placebo,letrozole placebo and berberine.Data and blood were collected at baseline,the third month and sixth month after treatment,or immediately were collected if subject was pregnant.Statisticians and clinical investigators were blinded to treatment allocation and treatment related study results until the central database was locked for final data extraction and analysis determined.The statistical analysis plan described basic analysis principles,methods commonly encountered in data analysis issues,and the specific statistical procedures for analyzing the primary,secondary,and safety outcomes.Ethics and dissemination:The study was approved by the ethics committee of the First Affiliated Hospital,Heilongjiang University of Chinese Medicine.The study findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration:Chinese Clinical Trial Registry:Chi CTR-TRC-09000376.Clinical Trials.gov identifier:NCT01116167.
