• 1
    Altman DG. Statistics in medical journals. Statistics Med 1982;1:5971.
  • 2
    Altman DG. Statistics in medical journals. Development in the 1980s. Statistics Med 1991;10:18971913.
  • 3
    . Editorial: The scandal of poor medical research. Br Med J 1994;308:283284.
  • 4
    Emerson JD, Colditz GA. Use of statistical analysis in the New England Journal of Medicine. N Engl J Med 1983;309:709713.
  • 5
    Schoolman HM, Becktel JM, Best WR, Johnson AF. Statistics in medical research: principals versus practice. J Laboratory Clin Med 1968;71:357367
  • 6
    Noller KL, Melton LJ. Study design in perinatal medicine. Am J Perinatol 1985;2:250255.
  • 7
    Sacket DL. Rational therapy in the neurosciences: the role of the randomized trial. Stroke 1986;17:13231329.
  • 8
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidelines: Statistical Principals for Clinical Trials (ICH E-9). Available from URL:
  • 9
    Campbell MJ, Machin D. Medical Statistics. A commonsense approach, 3rd edn. Chichester: Wiley, 1999, 2831.
  • 10
    Fleming T. Surrogate endpoints in clinical trials. Drug Information J 1996;30:545551.
  • 11
    Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics Med 1989;8:431440.
  • 12
    McDowell I, Newell C. Measuring Health. A Guide to Rating Scales and Questionnaires. Oxford: Oxford University Press, 1987.
  • 13
    Streiner DL, Norman GR. Health Measurement Scales. A Practical Guide to Their Development and Use. Oxford: Oxford University Press, 1989.
  • 14
    Senn S. Statistical Issues in Drug Development. Chichester: Wiley, 1997,2829.
  • 15
    Bland M, Altman DG. Regression towards the mean. Br Med J 1994;308:1499.
  • 16
    Bland M, Altman DG. Some examples of regression towards the mean. Br Med J 1994;309:780.
  • 17
    Chuang-Stein C. The regression fallacy. Drug Information J 1993;27:12131220.
  • 18
    Armitage P, Fox W, Rose GA, Tinker CM. The variability of measurements of casual blood pressure II. Survey experience. Clin Sci 1966;30:337344.
  • 19
    Yudkin P, Stratton IM. How to deal with regression to the mean in intervention studies. Lancet 1996;347:241243.
  • 20
    Hayes RJ. Methods for assessing whether change depends on initial value. Statistics Med 1988;7:915927.
  • 21
    Pocock SJ. Randomised clinical trials. Br Med J 1977;i:1661.
  • 22
    Sacks HS, Chalmers TC, Smith H. Sensitivity and specificity of clinical trials: randomized v historical controls. Arch Intern Med 1983;143:753755.
  • 23
    Chalmers TC, Celano P, Sacks HS, Smith H. Bias in treatment assignment in controlled clinical trials. New Eng J Med 1983;309:13581361.
  • 24
    Schulz KF, Chalmers I, Hayes RJ, Altman DG. Bias due to non-concealment of randomization and non-double-blinding. J Am Med Assosiation 1995;273:408412.
  • 25
    Rothman KJ. Statistics in nonrandomized studies. Epidemiology 1990;1:417418.
  • 26
    Pocock SJ. Clinical Trials. Chichester: Wiley 1983, 7389.
  • 27
    Efron B. Forcing a sequential experiment to be balanced. Biometrika 1971;58:403417.
  • 28
    Atkinson A. Optimum biased coin designs for sequential clinical trials with prognostic factors. Biometrika 1982;69:6167.
  • 29
    Cochran WG. Sampling Techniques. New York: Wiley 1977.
  • 30
    Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Therapeutics 1974;15:443453.
  • 31
    Byerly H. Explaining and exploiting placebo effects. Pers Biol Med 1976;19:423435.
  • 32
    Karlowski TR, Chalmers TC, Frenkel LD et al. Ascorbic acid for the common cold. A prophylactic and therapeutic trail. JAMA 1975;231:10381042.
  • 33
    Bailar JC, Louis TA, Lavori PW, Polansky M. A classification for biomedical research reports. N Engl J Med 1984;311:14821487.
  • 34
    Breslow NE, Day NE. Statistical Methods in Cancer Research, Vol. 1. –the Analysis of Case-Control Studies. Oxford University Press, 1993 .
  • 35
    Schlesselman JJ. Case-control studies. Design Conduct, Analysis. Oxford University Press 1982.
  • 36
    Sacket DL. Bias in analytical research. J Chron Dis 1979;32:5163.
  • 37
    Rothman KJ, Greenland S. Modern Epidemiology. Philadelphia, PA: Lippincott-Raven 1998.
  • 38
    Mayes LC, Horwitz RI, Feinstein AR. A collection of 56 topics with contradictory results in case-control research. Int J Epidemiol 1988;17:680685.
  • 39
    Beck JD. Risk revisited. Community Dent Oral Epidemiol 1998;26:220225.
  • 40
    Kleinbaum D, Kupper L, Morgenstern H. Epidemiologic research: principals and quantitative methods. Belmont, CA: Lifetime Learning Publications 1982.
  • 41
    Hill B. Principals of medical statistics, 9th edn. New York: Oxford University Press 1971,309323.
  • 42
    Koch GG, Beck JD. Statistical methodologies useful for the analysis of data from risk-assesment studies. J Public Health Dent 1992;52:146167.
  • 43
    Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:18871892.
  • 44
    Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000;342:18781886.
  • 45
    Easterbrook PJ, Berlin JA. Publication bias in clinical research. Lancet 1991;337:867872.
  • 46
    Berlin JA, Colin BB, Louis TA. An assessment of publication bias using a sample of published clinical trials. J Am Stat Assosiation 1989;84:381392.
  • 47
    Freiman JA, Chalmers TC, Smith H, Kuebler RR. The importance of beta, the type II error, and sample size in the design and interpretation of the randomized controlled trial: survey of 71 ‘negative’ trials. N Engl J Med 1978;299:690694.
  • 48
    Altman DG, Bland M. Absence of evidence is not evidence of absence. Br Med J 1995;311:485.
  • 49
    Gardner MJ, Altman DG. Confidence intervals rather than P-values: estimation rather than hypothesis testing. Br Med J 1986;292:746750.
  • 50
    Moher D, Dulberg CS, Wells GA. statistical power, sample size, and their reporting in randomized controlled trials. JAMA 1994;272:122124.
  • 51
    Machin D, Campbell MJ, Fayers PM, Pinol APY. Sample Size Tables for Clinical Studies. Oxford: Blackwell Scientific 1997.
  • 52
    Desu MM, Rhaghavarao D. Sample Size Methodology. Boston: Academic Press 1990.
  • 53
    Bauer P. Multiple testing in clinical trials. Stat Med 1991;10:871890.
  • 54
    Pocock SJ, Geller N, Tsiatis A. The analysis of multiple endpoints in clinical trials. Biometrics 1987;43:487498.
  • 55
    Altman DG. Practical Statistics for Medical Research. London: Chapman & Hall 1991.
  • 56
    Bland M. An introduction to medical statistics, 3rd edn. Oxford: Oxford University Press 2000.
  • 57
    Campbell MJ, Machin D. Medical Statistics: A commonsence approach, 3rd edn. Chichester: Wiley 1999.
  • 58
    Pocock SJ. Clinical Trials. Chichester: Wiley 1983.
  • 59
    Senn S. Statistical Issues in Drug Development. Chichester: Wiley 1997.
  • 60
    Begg C, Cho M, Eastwood S et al. improving the quality of reporting of randomized controlled trials. CONSORT Statement. JAMA 1996;276:637639. (Also available at url:
  • 61
    Gardner MJ, Altman DG, eds. Statistics, with confidence. Confidence intervals and statistical guidelines. London: British Medical Journal 1989.
  • 62
    Sacks HS, Berrier J, Reitman D, Ancona-Berk VA, Chalmers TC. Meta-analyses of randomized controlled trials. New Eng J Med 1987;316:450455.