References

1 Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials, 3rd ed. St. Louis: Mosby, 1996; New York: Springer-Verlag, 1998.

► One of the leading texts on clinical trials methodology.

2 The Coronary Drug Project Research Group. Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. N Engl J Med 1980;303:1038-41.

► Classic paper showing that poor compliers to placebo had a worse survival experience than good compliers.

3 CASS Principal Investigators. Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Comparability of entry characteristics and survival in randomized patients and non-randomized patients meeting randomization criteria. J Am Coll Cardiol 1984;3:114-28.

4 Smith P, Arnesen H. Mortality in non-consenters in a post-myocardial infarction trial. J Intern Med 1990;228:253-6.

5 Guyatt GH, Keller JL, Jaeschke R, et al. The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. Ann Intern Med 1990;112:293-9.

6 Robins SJ, Collins D, Wittes J, et al. Relation of gemfibrozil treatment and lipid levels with major coronary events. VA-HIT: a randomized controlled trial. JAMA 2001;285:1585-91.

► Examined how much of the mortality/morbidity benefit of gemfibrozil could be explained by individual changes in HDL cholesterol. Only one quarter of the benefit was explained, thus concluding that gemfibrozil has important HDL cholesterol independent mechanism(s) of action.

7 Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The cardiac arrhythmia suppression trial. N Engl J Med 1991;324:781-8.

► CAST surprised the cardiology community by showing that drug induced suppression of premature ventricular depolarisations increased rather than decreased the risk of sudden death. The findings were a setback for believers in surrogate markers.

8 Furberg CD, Psaty BM, Pahor M, et al. Clinical implications of recent findings from the antihypertensive and lipid-lowering treatment to prevent hearth attack trial (ALLHAT) and other studies of hypertension. Ann Intern Med 2001;135:1074-8.

► A recent review of comparative trials strongly suggesting that it matters how raised blood pressure is lowered.

9 Davey Smith G, Egger M. Incommunicable knowledge? Interpreting and applying the results of clinical trials and meta-analyses. J Clin Epidemiol 1998;51:289-95.

► A thoughtful review of the central role clinicians have in applying trial results to individual patients.

10 Chalmers I. A patient's attitude to the use of research evidence for guiding individual choices and decisions in health care. ClinicalRisk 2000;6:227-30.

► An interesting commentary from the perspective of the patient.

11 Kââriâinen I, Sipponen P, Siurala M. What fraction of hospital ulcer patients is eligible for prospective drug trials? Scand J Gastroenterol 1991;26:73-6.

► One of the few studies that documented how trial eligibility criteria can undermine generalisability.

12 Schmucker DL, Vesell ES. Underrepresentation of women in clinical drug trials. Clin Pharmacol Ther 1993;54:11-15.

13 El-Sadr W, Capps L. The challenge of minority recruitment in clinical trials for AIDS. JAMA 1992;267:954-7.

14 Hutchins LF, UngerJM, Crowley JJ, et al. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. NEnglJ Med 1999;341:2061-7.

15 Connolly HM, CraryJL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine. N EnglJ Med 1997;337:581-8.

16 US Food and Drug Administration. FDA Public Health Advisory. Reports of valvular heart disease in patients receiving concomitant fenfluramine and phentermine. FDA Medical Bulletin 8 July 1997.

► A premature alarm overstating the magnitude of the fen-phen epidemic.

17 Anon. WSJ Survey, The Wall Street Journal. 31 October 1997.

► An example of balanced investigative reporting.

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