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1

Piantadosi, Steven. Clinical Trials. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2005. http://dx.doi.org/10.1002/0471740136.

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Pocock, Stuart J. Clinical Trials. West Sussex, England: John Wiley & Sons Ltd,., 2013. http://dx.doi.org/10.1002/9781118793916.

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Pawlik, Timothy M., and Julie A. Sosa, eds. Clinical Trials. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-35488-6.

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Mantel, Barbara. Clinical Trials. 2455 Teller Road, Thousand Oaks California 91320 United States: CQ Press, 2018. http://dx.doi.org/10.4135/cqresrre20180518.

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5

Lelia, Duley, and Farrell Barbara 1946-, eds. Clinical trials. London: BMJ Books, 2002.

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6

Rabinarayan, Dash. Clinical trials. New Delhi: Studera Press, 2017.

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7

Kelly, William Kevin, and Susan Halabi, eds. Oncology Clinical Trials. New York, NY: Springer Publishing Company, 2018. http://dx.doi.org/10.1891/9780826168733.

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8

Kerr, David J., Kirstine Knox, Diane C. Robertson, Derek Stewart, and Rene Watson, eds. Clinical Trials Explained. Malden, Massachusetts, USA: Blackwell Publishing Ltd, 2006. http://dx.doi.org/10.1002/9780470750612.

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9

Machin, David, and Peter M. Fayers. Randomized Clinical Trials. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2010. http://dx.doi.org/10.1002/9780470686232.

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10

Meinert, Curtis L. Clinical Trials Dictionary. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2012. http://dx.doi.org/10.1002/9781118315293.

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11

Flather, Marcus D., Deepak L. Bhatt, and Tobias Geisler, eds. Cardiovascular Clinical Trials. Oxford, UK: Blackwell Publishing Ltd., 2012. http://dx.doi.org/10.1002/9781118399378.

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12

Scheurlen, Hans, Richard Kay, and Michael Baum, eds. Cancer Clinical Trials. Berlin, Heidelberg: Springer Berlin Heidelberg, 1988. http://dx.doi.org/10.1007/978-3-642-83419-6.

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13

Iber, Frank L., W. Anthony Riley, and Patricia J. Murray. Conducting Clinical Trials. Boston, MA: Springer US, 1987. http://dx.doi.org/10.1007/978-1-4613-1919-1.

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14

Meinert, Curtis L. Clinical Trials Handbook. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2012. http://dx.doi.org/10.1002/9781118422878.

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15

Alper, Joe, Eeshan Khandekar, and Carolyn Shore, eds. Virtual Clinical Trials. Washington, D.C.: National Academies Press, 2019. http://dx.doi.org/10.17226/25502.

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16

Kevin, Kelly William, and Halabi Susan, eds. Oncology clinical trials. New York: Demos Medical, 2010.

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17

United States. Health Care Financing Administration. Medicare & clinical trials. Baltimore, MD: U.S. Dept. of Health and Human Services, Health Care Financing Administration, 2001.

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18

M, Finkelstein Dianne, and Schoenfeld David A, eds. AIDS clinical trials. New York: Wiley-Liss, 1995.

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19

Ryszard, Gryglewski, Szczeklik Andrzej, and McGiff John C, eds. Prostacyclin, clinical trials. New York: Raven Press, 1985.

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20

1948-, Gad Shayne C., ed. Clinical trials handbook. Hoboken, N.J: Wiley, 2009.

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21

Anthony, Riley W., and Murray Patricia J, eds. Conducting clinical trials. New York: Plenum Medical Book Co., 1987.

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22

1939-, Machin David, Day Simon, and Green Sylvan B, eds. Textbook of clinical trials. 2nd ed. Chichester, West Sussex, England: Wiley, 2006.

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23

Friedman, Lawrence M., Curt D. Furberg, David L. DeMets, David M. Reboussin, and Christopher B. Granger. Fundamentals of Clinical Trials. Cham: Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-18539-2.

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24

Machin, David, Simon Day, and Sylvan Green, eds. Textbook of Clinical Trials. Chichester, UK: John Wiley & Sons, Ltd, 2004. http://dx.doi.org/10.1002/0470020245.

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25

Mihajlovic-Madzarevic, Vera. Clinical Trials Audit Preparation. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2010. http://dx.doi.org/10.1002/9780470572757.

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26

Hertzman, Marc, and Lawrence Adler, eds. Clinical Trials in Psychopharmacology. Chichester, UK: John Wiley & Sons, Ltd, 2010. http://dx.doi.org/10.1002/9780470749180.

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27

Friedman, Lawrence M., Curt D. Furberg, and David L. DeMets. Fundamentals of Clinical Trials. New York, NY: Springer New York, 1998. http://dx.doi.org/10.1007/978-1-4757-2915-3.

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28

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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29

Ravina, Bernard, Jeffrey Cummings, Michael McDermott, and Michael Poole, eds. Clinical Trials in Neurology. Cambridge: Cambridge University Press, 2012. http://dx.doi.org/10.1017/cbo9781139032445.

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30

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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31

Katz, Martin M. Clinical Trials of Antidepressants. Cham: Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-26464-6.

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32

Nasir, Adnan, ed. Clinical Dermatology Trials 101. Cham: Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-09027-6.

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33

Harrington, David, ed. Designs for Clinical Trials. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4614-0140-7.

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34

Mueller, Ruediger, and Johannes von Kempis. Clinical Trials in Rheumatology. London: Springer London, 2013. http://dx.doi.org/10.1007/978-1-4471-2870-0.

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35

Pearson, Derek, and Colin G. Miller, eds. Clinical Trials in Osteoporosis. London: Springer London, 2007. http://dx.doi.org/10.1007/978-1-84628-587-5.

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36

Pearson, Derek, and Colin G. Miller, eds. Clinical Trials in Osteoporosis. London: Springer London, 2002. http://dx.doi.org/10.1007/978-1-4471-3710-8.

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37

Guiloff, Roberto J., ed. Clinical Trials in Neurology. London: Springer London, 2001. http://dx.doi.org/10.1007/978-1-4471-3787-0.

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38

Machin, David, Simon Day, and Sylvan Green, eds. Textbook of Clinical Trials. Chichester, UK: John Wiley & Sons, Ltd, 2006. http://dx.doi.org/10.1002/9780470010167.

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39

Mueller, Ruediger, and Johannes Von Kempis. Clinical Trials in Rheumatology. London: Springer London, 2011. http://dx.doi.org/10.1007/978-1-84996-384-8.

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40

Green, Stephanie, Jacqueline Benedetti, and John Crowley. Clinical Trials in Oncology. Boston, MA: Springer US, 1997. http://dx.doi.org/10.1007/978-1-4899-3352-2.

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41

Bulpitt, Christopher J. Randomised Controlled Clinical Trials. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1.

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42

Fregni, Felipe, ed. Clinical Trials in Neurology. New York, NY: Springer New York, 2018. http://dx.doi.org/10.1007/978-1-4939-7880-9.

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43

Friedman, Lawrence M., Curt D. Furberg, and David L. DeMets. Fundamentals of Clinical Trials. New York, NY: Springer New York, 2010. http://dx.doi.org/10.1007/978-1-4419-1586-3.

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44

Raven, Ann. Clinical trials: An introduction. 2nd ed. Oxford: Radcliffe Medical Press, 1993.

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45

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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46

Wiffen, Philip, Marc Mitchell, Melanie Snelling, and Nicola Stoner. Clinical trials. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198735823.003.0005.

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This chapter outlines information relevant to clinical pharmacists related to clinical trials. In particular, this chapter covers clinical trial regulations and the European Clinical Trials Directive, development phases and licensing of clinical trials, hospital pharmacy guidance on setting up and running clinical trials, clinical trial design, and ethical committees.
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47

(Editor), Derek Pearson, and Colin G. Miller (Editor), eds. Clinical Trials in Osteoporosis (Clinical Trials). 2nd ed. Springer, 2007.

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48

Hutchinson, D. Why Clinical Trials Fail (Clinical Trials). Brookwood Medical Publications Ltd, 1997.

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49

Stewart, Simon. Clinical Trials. John Wiley & Sons, 2007.

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50

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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