• 1
    Johnson JA. Advancing management of hypertension through pharmacogenomics. Ann Med. 2012;44(suppl 1):S17S22.
  • 2
    Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension. 2003;42:12061252.
  • 3
    National Library of Medicine. Dr Frances Kathleen Oldham Kelsey. Accessed July 26, 2012.
  • 4
    Derenzo D, Moss J. Writing Clinical Research Protocols: Ethical Perspectives. San Diego: Elsevier; 2006.
  • 5
    Turner JR. New Drug Development: An Introduction to Clinical Trials, 2nd edn. New York: Springer; 2010.
  • 6
    Turner JR. Editor’s commentary: ethics in clinical research. Drug Inform J. 2012;46:155157.
  • 7
    US Department of Health & Human Services Web site. Accessed July 26, 2012.
  • 8
    Primrose SB, Twyman RM. Principles of Gene Manipulation and Genomics. Malden, MA: Blackwell Publishing; 2006.
  • 9
    Encyclopedia Britannica web site. Accessed July 26, 2012.
  • 10
    Fisher RA. Statistical Methods and Scientific Inference. Oxford, UK: Hafner Publications Co.; 1956.
  • 11
    Fisher RA. The arrangement of field experiments. J Ministry Agriculture. 1926;33:503513.
  • 12
    Fisher RA. Expansion of statistics. Am Sci. 1954;42:27582.
  • 13
    Turner JR. Key Statistical Concepts in Clinical Trials for Pharma. New York: Springer; 2012.
  • 14
    Durham TA, Turner JR. Introduction to Statistics in Pharmaceutical Clinical Trials. London: Pharmaceutical Press; 2008.
  • 15
    Meier P. Statistics and medical experimentation. Biometrics. 1975;31:511529.
  • 16
    Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141145.
  • 17
    Avorn J. In defense of pharmacoepidemiology: embracing the yin and yang of drug development. N Engl J Med. 2007;357:22192221.
  • 18
    Turner JR. Editor’s commentary. Drug Inform J. 2011;45:687689.
  • 19
    Matthews JNS. Introduction to Randomized Controlled Clinical Trials. London: Edward Arnold; 1999.
  • 20
    MRC Streptomycin in Tuberculosis Trials Committee. Streptomycin treatment of pulmonary tuberculosis. Br Med J. 1948;2:769783.
  • 21
    Yoshioka A. Use of randomisation in the Medical Research Council’s clinical trial of streptomycin in pulmonary tuberculosis in the 1940s. Br Med J. 1998;317:12201223.
  • 22
    Lienhardt C, Raviglione M, Spigelman M, et al. New drugs for the treatment of tuberculosis: needs, challenges, promise, and prospects for the future. J Infect Dis. 2012;205(suppl 2):S241249.
  • 23
    Phillips PP, Gillespie SH, Boeree M, et al. Innovative trial designs are practical solutions for improving the treatment of tuberculosis. J Infect Dis. 2012;205(suppl 2):S250257.
  • 24
    Cook TD, DeMets DL. Introduction to Statistical Methods for Clinical Trials. Boca Raton, FL: Chapman & Hall/CRC; 2008.
  • 25
    The coronary drug project research group. Clofibrate and niacin in coronary heart disease. JAMA. 1975;231:360381.
  • 26
    Canner PL, Berge KG, Wenger NK, et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986;8:12451255.
  • 27
    Five-year findings of the hypertension detection and follow-up program. III. Reduction in stroke incidence among persons with high blood pressure. Hypertension Detection and Follow-up Program Cooperative Group. JAMA. 1982;247:633638.
  • 28
    The coronary primary prevention trial: design and implementation: the Lipid Research Clinics Program. J Chronic Dis. 1979;32:609631.
  • 29
    Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344:13831389.
  • 30
    Rader DJ. Editorial. Illuminating HDL — is it still a viable therapeutic target? N Engl J Med. 2007;357:21802183.
  • 31
    Barter PJ, Caulfield M, Eriksson M, et al. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. 2007;357:21092122.
  • 32
    Turner JR, Durham TA. Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance. Hoboken, NJ: Wiley; 2009.
  • 33
    Kay R. Statistical Thinking for Non-Statisticians in Drug Regulation. Chichester, UK: Wiley; 2007.
  • 34
    Turner JR. Editor’s commentary: meta-methodology. Drug Inform J. 2011;45:405411.
  • 35
    Katz DL. Clinical Epidemiology & Evidence-Based Medicine: Fundamental Principles of Clinical Reasoning & Research. Thousand Oaks, CA: Sage Publications; 2001.