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Books on the topic 'Clinical Trial Randomization'

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Author: Grafiati

Published: 10 December 2022

Last updated: 29 January 2023

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1

Rosenberger, William F., and John M. Lachin. Randomization in Clinical Trials. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2002. http://dx.doi.org/10.1002/0471722103.

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2

Rosenberger, William F., and John M. Lachin. Randomization in Clinical Trials. Hoboken, NJ, USA: John Wiley & Sons, Inc, 2016. http://dx.doi.org/10.1002/9781118742112.

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3

Rosenberger, William F. Randomization in clinical trials: Theory and practice. New York: Wiley, 2002.

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4

1942-, Lachin John M., ed. Randomization in clinical trials: Theory and practice. Hoboken, New Jersey: John Wiley & Sons, Inc., 2016.

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5

F, Rosenberger William, ed. The theory of response-adaptive randomization in clinical trials. Hoboken, NJ: John Wiley & Sons, 2006.

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6

Hu, Feifang, and William F. Rosenberger. The Theory of Response-Adaptive Randomization in Clinical Trials. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2006. http://dx.doi.org/10.1002/047005588x.

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7

Neil, Klar, ed. Design and analysis of cluster randomization trials in health research. London: Arnold, 2000.

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8

Haynes, Richard, Martin J. Landray, William G. Herrington, and Colin Baigent. Clinical trials. Edited by Christopher G. Winearls. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199592548.003.0019.

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Randomized trials are the best method for identifying and quantifying the benefits and risks of interventions in clinical practice. Nephrology lags behind most specialties in medicine in its evidence base. Many commonly used therapies are untested and may be ineffective or even cause harm. For trials to provide reliable answers to important clinical questions they must first avoid two sources of error. Firstly, systematic error (or bias) can only be removed by proper randomization. Secondly, random error (the play of chance) can only be removed by the randomization of large numbers of patients (and therefore the accrual of large numbers of trial outcomes). Following successful large-scale randomization, it is critical that patients’ compliance with their allocated treatment is maintained, relevant study outcomes are systematically ascertained, and appropriate statistical analyses are performed. There is an urgent need to conduct such trials to address the many important clinical questions in nephrology.

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9

Wiffen, Philip, Marc Mitchell, Melanie Snelling, and Nicola Stoner. Clinical trials. Oxford University Press, 2012. http://dx.doi.org/10.1093/med/9780199603640.003.0005.

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Clinical trial regulations 108Licensing of a clinical trial 109Clinical trial development phases 110Trial design, randomization, and blinding 111European Clinical Trials Directive 112Clinical trials: hospital pharmacy guidance 114Ethical committees 116Clinical trials form a fundamental part in the research, development, and licensing of new medicines. Research of how the drug interacts in humans is essential to ensure safe and effective medicines are licensed as new treatments. It is an exciting and varied role at the cutting edge of modern research with trials ranging across all therapeutic specialities. Clinical Trial pharmacists are therefore required to have a broad clinical knowledge and a specialist knowledge of the regulations that clinical trials have to follow....

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10

Hershberger, Scott L. Multivariate Clinical Trials For Randomized Experiments In The Behavioral Sciences. Psychology Press, 2011.

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11

Howell, Simon J. Clinical trial designs in anaesthesia. Edited by Jonathan G. Hardman. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199642045.003.0030.

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A clinical trial is a research study that assigns people or groups to different interventions and compares the impact of these on health outcomes. This chapter examines the design and delivery of clinical trials in anaesthesia and perioperative medicine covering the issues outlined below. The features of a high-quality clinical trial include well-defined inclusion and exclusion criteria, a control group, randomization, and blinding. Outcome measures may be broadly divided into counting the number of people who experience an outcome and taking measurements on people. The outcome measures selected for a clinical trial reflect the purpose of the study and may include ‘true’ clinical measures such as major postoperative complications or surrogate measures such as the results of a biochemical test. Outcome measures may be combined in a composite outcome. Assessment of health-related quality of life using a tool such as the SF-36 questionnaire is an important aspect of many clinical trials in its own right and also informs the economic analyses that may be embedded in a trial. Determining the number for recruits needed for a clinical trial requires both clinical and statistical insight and judgement. The analysis of a clinical trial requires a similarly sophisticated approach that takes into account the objectives of the study and balances the need for appropriate subgroup analyses with the risk of false-positive results. The safe and effective management of a clinical trial requires rigorous organizational discipline and an understanding of the ethical and regulatory structures that govern clinical research.

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12

Farrar, John T. Understanding clinical trials in palliative care research. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199656097.003.0193.

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Advances in basic science, translational, and clinical research have led to rapid improvements in our understanding of many disease processes. The randomized clinical trial (RCT) has played an important role in validating the benefits and harms of therapies thought to be potentially useful based on scientific theory or clinical observation, and has become the ‘gold standard’ for the demonstration of efficacy. As in all clinical study designs, the RCT has strengths and weaknesses that must be understood to appropriately interpret the study results. While randomization of the intended study population is the primary strength of such trials, choice of the study population, control condition, outcome measures, analysis procedure, and procedures for blinding the study participants can all affect the results. Understanding the requirements of a valid RCT and what can potentially go wrong will improve the conduct of palliative care research and the usefulness of published information in the care of patients.

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13

Berger, Vance. Randomization Masking and Allocation Concealment. Taylor & Francis Group, 2020.

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14

Berger, Vance. Randomization, Masking, and Allocation Concealment. Taylor & Francis Group, 2017.

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15

Berger, Vance. Randomization, Masking, and Allocation Concealment. Taylor & Francis Group, 2017.

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16

Berger, Vance. Randomization, Masking, and Allocation Concealment. Taylor & Francis Group, 2017.

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17

Berger, Vance. Randomization, Masking, and Allocation Concealment. Taylor & Francis Group, 2017.

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18

Randomization, Masking, and Allocation Concealment. Taylor & Francis Group, 2017.

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19

Kaasa, Stein, and Karen Forbes. Research in palliative care. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199656097.003.0191.

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Research in palliative care is essential for maintaining standards and advancing knowledge and improving practice. It is challenging, sometimes daunting, often frustrating, but always exciting and rewarding when a study is successfully completed, whether the outcome is positive or negative. This chapter discusses a wide range of topics that will help those who are new to research to get started, to proceed and complete it, and contribute to improving outcomes for patients with advanced disease. Topics include, among others, collaborative and translational research, research governance, controlled clinical trials, evidence-based palliative care, and trial planning (including methodology, randomization, statistical considerations, protocol, access to patients, finance, administration, monitoring, and publication).

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20

Rosenberger, William F., and John M. Lachin. Randomization in Clinical Trials: Theory and Practice. Wiley & Sons, Incorporated, John, 2015.

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21

Rosenberger, William F., and John M. Lachin. Randomization in Clinical Trials: Theory and Practice. Wiley & Sons, Incorporated, John, 2015.

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22

Rosenberger, William F., John M. Lachin, and Lachin John M. III. Randomization in Clinical Trials: Theory and Practice. Wiley & Sons, Incorporated, John, 2004.

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23

Rosenberger, William F., and Feifang Hu. Theory of Response-Adaptive Randomization in Clinical Trials. Wiley & Sons, Incorporated, John, 2006.

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24

Rosenberger, William F., and Feifang Hu. Theory of Response-Adaptive Randomization in Clinical Trials. Wiley & Sons, Incorporated, John, 2006.

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25

Rosenberger, William F., and John M. Lachin. Randomization in Clinical Trials: Theory and Practice. Wiley & Sons, Limited, John, 2015.

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26

Rosenberger, William F., and John M. Lachin. Randomization in Clinical Trials: Theory and Practice. Wiley & Sons, Incorporated, John, 2008.

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27

Rosenberger, William F., and John M. Lachin. Randomization in Clinical Trials: Theory and Practice. Wiley & Sons, Incorporated, John, 2015.

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28

Kulkarni, Kunal, James Harrison, Mohamed Baguneid, and Bernard Prendergast, eds. The history of evidence-based medicine. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198729426.003.0001.

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The pursuit of tests for therapeutic interventions has been a characteristic of Western medicine since ancient times. Historical accounts of the clinical trial are usually expressed through the lens of presentism: how the various components of the first modern randomized controlled trial-the comparison, blinding, and randomization-culminated in Austin Bradford Hill’s 1946 trial of streptomycin for tuberculosis. The factual context of the development of the randomized controlled trial is important if only to emphasize the historicity of contemporary research methodology. However, the adoption of the various components of the trial at any one time has as much to do with changing the socio-political and ethical contexts as the ‘objective’ scientific standards of evidence. Evidence is not just scientific data floating in some ethereal medium, but is also linked to facts and beliefs of the various members of diverse medical communities who interpret evidence and deploy it to legitimize various strategies. This introductory chapter aims to present the background and context through which evidence-based medicine has emerged.

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29

Rosenberger, William F., and Feifang Hu. The Theory of Response-Adaptive Randomization in Clinical Trials (Wiley Series in Probability and Statistics). Wiley-Interscience, 2006.

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30

Donner, Allan, and Neil Klar. Design and Analysis of Cluster Randomization Trials in Health Research. Wiley & Sons, Incorporated, John, 2010.

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31

Bluhm, Robyn. Inductive Risk and the Role of Values in Clinical Trials. Oxford University Press, 2017. http://dx.doi.org/10.1093/acprof:oso/9780190467715.003.0010.

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This chapter examines the implications of clinical research for philosophical discussions of inductive risk, focusing on three methodological debates: (1) the necessity of randomization, (2) the distinction between explanatory and pragmatic trials, and (3) the use of placebo versus active controls. All of these debates can usefully be recast in terms of inductive risk, which raises several important implications for philosophical discussion. They show that consideration of inductive risk, first, need not involve a straightforward trade-off between the consequences of false positive versus false negative results, and, second, should address what kind of evidence is needed before accepting a hypothesis, in addition to how much evidence is needed. Moreover, they show that evidence itself is shaped by non-epistemic values, which complicates the issue of distinguishing between direct and indirect roles for values.

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