Review of current controversial issues in clinical trials
作者机构：Department of Biostatistics and BioinformaticsDuke University School of MedicineDurhamNorth CarolinaUSA Kansas City UniversityCollege of Osteopathic MedicineKansas CityMissouriUSA Merck&Co IncKenilworthNew JerseyUSA
出 版 物：《General Psychiatry》 (综合精神医学（英文）)
年 卷 期：2021年第34卷第5期
页 面：16-22页
核心收录：
学科分类：1006[医学-中西医结合] 1002[医学-临床医学] 100602[医学-中西医结合临床] 10[医学]
主 题：clinical whenever independence
摘 要：In clinical development,adequate and well-controlled randomised clinical trials are usually conducted to evaluate the safety and efficacy of test treatment under *** purpose is to ensure that there is an accurate and reliable assessment of test treatment under *** practice,however,some controversial issues inevitably appear despite the compliance of good clinical *** debatable issues include,but are not limited to,(1)appropriateness of hypotheses for clinical investigation,(2)feasibility of power calculation for sample size requirement,(3)integrity of randomisation/blinding,(4)strategy for clinical endpoint selection,(5)demonstrating effectiveness or ineffectiveness,(6)impact of protocol amendments and(7)independence of independent data monitoring *** this article,these controversial issues are *** impact of these issues in evaluating the safety and efficacy of the test treatment under investigation is also *** regarding possible resolutions to these issues are provided whenever possible.
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