02356    a2200337   4500001001100000005001700011008003900028020001800067037003600085040000700121041000800128072001400136072001600150072001700166072001500183072001200198072001400210072001500224072001300239072002100252072002100273072002100294100001600315245005200331250000600383260003500389300001000424520154800434700002101982999001502003036778339820250317100400.0250312042021xx                   eng    a9780367783396  bTaylor & FranciscGBP 47.99fBB  a01  aeng7 aPS2thema7 aTDCW2thema7 aMBGR12thema7 aPBT2thema7 aPS2bic7 aTDCW2bic7 aMBGR12bic7 aPBT2bic7 aMAT0290002bisac7 aMED0710002bisac7 a615.507242bisac1 aScott Evans10aFundamental Concepts for New Clinical Trialists  a1  bChapman and Hall/CRCc20210331  a348 p  bFundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.1 aNaitee Ting4A01  c1160d1160