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001			200454102
999			_c200454102 _d72314
003			TR-AnTOB
005			20241115090248.0
006			m o d
007			cr cnuaaaau
008			201001s2021 nju ob 001 0 eng
020			_a9781119524649 _q(paperback)
020			_z9781119524656 _q(e-book)
020			_z9781119524670 _q(epub)
020			_z9781119524687 _q(o-book)
040			_aDNLM/DLC _beng _erda _cDLC _dTR-AnTOB
041	0		_aeng
060	0	0	_aW 20.55.C5 _bM149 2021
096			_aW20.55.C5 _bM149 2021 EBK
100	1		_aMachin, David _eauthor _9143144
245	1	0	_aRandomised clinical trials : _bdesign, practice and reporting / _cDavid Machin, Peter M. Fayers, Bee Choo Tai.
250			_aSecond edition
264		1	_aNew Jersey : _bWiley-Blackwell, _c2021.
300			_a1 online resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
500			_aİncludes index.
505	0		_aDesign Features -- The Trial Protocol -- Measurement and Data Capture -- Randomisation -- Trial Initiation -- Trial Conduct and Completion -- Basics for Analysis -- Trial Size -- Data and Safety Monitoring -- Reporting -- More than Two Interventions -- Paired and Matched Designs -- Repeated Measures Design -- Non-Inferiority and Equivalence Trials -- Cluster Designs -- Stepped Wedge Designs -- Genomic Targets -- Feasibility and Pilot Studies -- Further Topics.
520			_a"It is now more than ten years since the first edition of this book was published. In the intervening years, while many things have remained unchanged, there have also been many new developments over the period. This second edition refreshes the first, refining some of the sections to better explain their contents and, at the same time, replacing some examples with more current illustrations. To reflect the changes, we have created new chapters by splitting and then expanding old chapters. Thus, we now include full chapters on data and safety monitoring including interim analyses of accumulating data, cluster designs, repeated measures, and non-inferiority designs as there has been a rapid increase in the use of such trial designs along with some methodological developments and improvements in statistical software available for analysis. In addition, we have included entirely new chapters on stepped wedge designs, genomic targets and, feasibility and pilot studies. The chapter on stepped wedge designs reflects the growing importance of such complex intervention designs while that on genomic targets highlights the research focus directed towards more individualised medicine. In contrast the new chapter concerned with feasibility and pilot studies brings us back to the early planning stages of the clinical trial which is planned. The chapter is included as there is increasing recognition that perhaps a more structured approach is required at the planning stage of any proposed trial. The intention is to help avoid the conduct of clinical trials which fail due to the basic assumptions made at the planning stage being inappropriate. This edition is divided into three sections: I Basic Considerations, II Adaptions of the Basic Design, and III Further Topics. As the title suggests, the first section is intended to cover topics that are relevant to all randomised trials of whatever design and complexity. Thus, it may be the key section for those who are new to clinical trials and an aide-memoire for those more experienced in this area. For this purpose, it concentrates on the parallel two-group controlled trial with a single outcome measure where patients are randomised individually to one of the two interventions concerned. The second section expands on the individually randomised design in several ways by considering paired designs, repeated assessments of the (same) outcome measure over time, more than two interventions, and non-inferiority trials. It also includes cluster trials, and stepped wedge designs in which groups rather than individuals are randomised to the interventions concerned. The final section deals with genomic targets, feasibility and pilot studies, and a final chapter on miscellaneous topics including adaptive designs, large simple trials and very small trials with new additions describing alpha spending functions and the predictive probability test for use in interim analyses"-- _cProvided by publisher.
650		2	_aRandomized Controlled Trials as Topic _xmethods _9143145
650		2	_aBiomedical Research _xmethods _9128330
650		2	_aResearch Design _999434
655		0	_aElectronic books _92032
700	1		_aFayers, Peter M. _eauthor _9143146
700	1		_aTai, Bee Choo _eauthor _9143147
856	4	0	_zOnline access link to the resource _uhttps://onlinelibrary.wiley.com/doi/book/10.1002/9781119524687
942			_2NLM _cEBK