Share

Clinical Trials

10. References

Altman DG. (1999). Practical Statistics for medical research. London: Chapman and Hall.

Altman DG, Schulz KF, Moher D, et al. (2001). The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Intern Med;134: 663–94.

Arezina R, Wang D. (2006). Source and control of bias. In: D Wang & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica. 55-64.

Bakhai A, Chhabra A, Wang D. (2006a). Endpoints. In: D Wang & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica. 37-45.

Bakhai A, Patel S, Wang D. (2006b). Blinding. In: D Wang & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica. 75-80.

Bakhai A, Sudhir R, Wang D. (2006c). Equivalence Trials.In: D Wang & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica. 113-118.

Chow SC, Liu JP. (1998). Design and analysis of clinical trials: Concept and methodologies. Chichester: John Wiley & Sons.

Chow SC, Shao J, Wang H. (2003). Sample size calculation in clinical research. New York: Marcel.

Chow SC, Shao J, and Wang, H (2007). Sample size calculations in clinical research. 2nd edition. Chapman Hall/CRC Press, Taylor & Francis: New York.

Cox DR, Oakes D. (1984). Analysis of survival data. London: Chapman and Hall.

Day S. (1999). Dictionary of clinical trials. Chichester: John Wiley & Sons.

Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. Available from: http://www.wma.net/en/30publications/10policies/b3/index.html. Accessed May 6, 2005.

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Union 2001;121:34.

Everitt BS, Pickles A. (1999). Statistical aspects of the design and analysis of clinical trials. London: Imperial College Press.

FDA, Regulations Relating to Good Clinical Practice and Clinical Trials. Available from: http://www.fda.gov/oc/gcp/regulations.html. Accessed May 6, 2005.

FDA, Section 5.8 of the International Conference on Harmonization: Guidance on Statistical Principles for Clinical Trials. Available from: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm114928.htm. Accessed March 31, 2005.

Fox Z, et al. (2006). Factorial design. In: D Wang & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica. 101-112.

Friedman LM, Furberg CD, Demets D. (1998). Fundamentals of clinical trials, 3rd edition. New York: Springer Verlag.

International Conference on Harmonisation. E6: Good Clinical Practice: Consolidated Guidelines. Available from:http: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm114928.htm Accessed May 6, 2005.

Jadad AR. (1998). Randomized controlled trials: A user’s guide. London: BMJ Books.

Jones B, Kenward MG. (2003). Design and analysis of cross-over trials, 2nd edition. London: Chapman and Hall/CRC.

Kirkwood B, Sterne J. (2003). Essential medical statistics, 2nd edition. Oxford: Blackwell Publishing.

Mallick U, et al. (2006a). Protocol development. In: D Wang & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica. 23-36.

Mallick U, et al. (2006b). Cluster randomized trials. In: D Wang & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica.141-151.

Matthews JNS. (2000). Introduction to randomized controlled clinical trials. London: Arnold.

Miller S, Neate C, Wang D. (2006). Noninferiority trials. In: D Wang & A Bakhai, (Ed.s). Clinical Trials: A practical guide to design, analysis and reporting. London: Remedica. 131-140.

Pocock SJ. (1983). Clinical trials: A practical approach. Chichester: John Wiley & Sons.

Senn S. (2002). Cross-over trials in clinical research, 2nd edition. Chichester: John Wiley & Sons.

Steele, F. Wang, D. (2006). Regression Analyses. In: D Wang & A Bakhai A, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 273-286.

Truesdale A, Bakhai A, Wang D. (2006). Multicenter trials. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 153-163.

Wang D & Bakhai A, editors. (2006). Clinical Trials: A Practical Guide to Design, Analysis and Reporting. London: Remedica.

Wang D, Bakhai A. (2006a). Randomization. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 65-73.

Wang D, Bakhai A. (2006b). Sample Size and Power. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 81-87.

Wang D, Arezina R, Bakhai A. (2006a). Bioequivalence Trials. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 119-130.

Wang D, Clayton T, Bakhai A. (2006b). Analysis of Survival Data. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 235-254.

Wang D. Clayton T, Bakhai A. (2006c). Confounding. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 295-304.

Wang D, Clayton T, Clemens F. (2006d). Comparison of Proportions. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 217-234.

Wang D, Clayton T, Yan H. (2006e). Significance Tests and Confidence Intervals. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 185-196.

Wang D, Clemens F, Clayton T. (2006f). Comparison of Means. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 197-216.

Wang D, Lorch U, Bakhai A. (2006g). Crossover Trials. In: D Wang & A Bakhai, (Ed.s). Clinical trials: A practical guide to design, analysis and reporting. London: Remedica. 91-99.

Yusuf S, Zhao F, Mehta SR et al. (2001). Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med;345: 494–502.