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Influences on the Quality of Published Drug Studies

Published online by Cambridge University Press:  10 March 2009

Lisa A. Bero  and
Drummond Rennie
Lisa A. Bero
Affiliation:
University of California, San Francisco
Drummond Rennie
Affiliation:
University of California, San Francisco
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Abstract

To practice evidence-based medicine, physicians need data on the clinical effectiveness, toxicity, convenience, and cost of new drugs compared with available alternatives. We give examples of published drug studies that are defective, sometimes because pharmaceutical industry funding has affected their content and quality. We make recommendations on how to avoid these defects.

Information

Type
Special Section: The Quality of the Medical Evidence: Is It Good Enough?
Information
International Journal of Technology Assessment in Health Care , Volume 12 , Issue 2 , Spring 1996 , pp. 209 - 237
Copyright
Copyright © Cambridge University Press 1996

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References

REFERENCES

1.Altman, D. G.Statistics in medical journals. Statistics in Medicine, 1982, 1, 59–71.CrossRefGoogle ScholarPubMed
2.Anders, G. Testing a new drug entails daunting costs and clashing interests. Wall Street Journal, 01 7, 1994, 5–7.Google Scholar
3.Anderson, J. J., Felson, D. T., & Meenan, R. F.Secular changes in published clinical trials of second-line agents in rheumatoid arthritis. Journal of Laboratory and Clinical Medicine, 1991, 34, 1304–09.Google ScholarPubMed
4.Angell, M., & Relman, A. S.Redundant publication. New England Journal of Medicine, 1989, 320, 1212–14.CrossRefGoogle ScholarPubMed
5.Anturane Reinfarction Trial Policy Committee. The Anturane reinfarction trial: Reevaluation of outcome. New England Journal of Medicine, 1982, 306, 1005–08.CrossRefGoogle Scholar
6.Assmann, G., & Brewer, J.Genetic (primary) forms of hypertriglyceridemia. American Journal of Cardiology, 1991, 68, 13A–16A.CrossRefGoogle ScholarPubMed
7.Bailey, B. J.Duplicate publication in otolaryngology: Head and neck surgery. Program and abstracts of the First International Congress on Peer Review in Biomedical Publication, Chicago, 1989.Google Scholar
8.Bero, L. A.Gailbraith, A., & Rennie, D.Sponsored symposia and their publication in medical journals, University of California-San Francisco, Institute for Health Policy Studies, 1992, monograph.Google Scholar
9.Bero, L. A.Gailbraith, A., & Rennie, D.The publication of sponsored symposiums in medical journals. New England Journal of Medicine, 1992, 327, 1135–40.CrossRefGoogle ScholarPubMed
10.Bero, L. A., & Glantz, S. G.Tobacco industry response to a risk assessment of environmental tobacco smoke. Tobacco Control, 1993, 2, 103–13.CrossRefGoogle Scholar
11.Bierut, M. B.The Prescription Drug User Fee Act of 1992: Speeding up the drug approval process. Healthspan, 1992, 9, 12–14.Google ScholarPubMed
12.Bobbio, M., Demichelis, B., & Giustetto, G.Completeness of reporting trial results: Effect on physicians’ willingness to prescribe. Lancet, 1994, 343, 1209–11.CrossRefGoogle ScholarPubMed
13.Bond, G. G.Ethical issues relating to the conduct and interpretation of epidemiologic research in private industry. Journal of Clinical Epidemiology, 1991, 44, 29S–34S.CrossRefGoogle Scholar
14.Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction [special report]. New England Journal of Medicine, 1989, 321, 406–12.CrossRefGoogle Scholar
15.Carette, S., Bell, M. J., Reynolds, W. J., et al. Comparison of amitriptyline.cyclobenzaprine, and placebo in the treatment of fibromyalgia. Arthritis and Rheumatism, 1994, 37, 32–40.CrossRefGoogle ScholarPubMed
16.Cavalli, F.Our policy regarding supplements of sponsored symposia. Annals of Oncology, 1993, 4, 99.CrossRefGoogle Scholar
17.Chalmers, I.Underreporting research is scientific misconduct. Journal of the American Medical Association, 1990, 263, 1405–08.CrossRefGoogle ScholarPubMed
18.Chalmers, I., Dickersin, K., & Chalmers, T. C.Getting to grips with Archie Cochrane’s agenda. British Medical Journal, 1992, 305, 786–88.CrossRefGoogle ScholarPubMed
19.Chalmers, T. C., Frank, C. S., & Reitman, D.Minimizing the three stages of publication bias. Journal of the American Medical Association, 1990, 263, 1392–95.CrossRefGoogle ScholarPubMed
20.Chalmers, T. C., Harry Smith, J., Blackburn, B., et al. A method for assessing the quality of a randomized control trial. Controlled Clinical Trials, 1981, 2, 31–49.CrossRefGoogle ScholarPubMed
21.Charny, M.Publication bias [letter to the editor]. Lancet, 1991, 337, 1102.Google Scholar
22.Cho, M. K., & Bero, L. A.Instruments for assessing the quality of drug studies published in the medical literature. Journal of the American Medical Association, 1994, 272, 101–04.CrossRefGoogle ScholarPubMed
23.Cho, M. K., & Bero, L. A.The quality of drug studies published in symposium proceedings. Annals of Internal Medicine, 1996, 124, 485–89.CrossRefGoogle ScholarPubMed
24.Colditz, G. A., Miller, J. A., & Mosteller, F.How study design affects outcomes in comparisons of therapy, I: Medical. Statistics in Medicine, 1989, 8, 441–54.CrossRefGoogle ScholarPubMed
25.Crevey, B. J., Dantzker, D. R., Bower, J. S., et al. Hemodynamic and gas exchange effects of intravenous diltiazem in patients with pulmonary hypertension. American Journal of Cardiology, 1982, 49, 578–83.CrossRefGoogle ScholarPubMed
26.Criswell, L. A., Katz, P. P., & Tack, B. B.No firm basis to advocate auranofin in the treatment of juvenile rheumatoid arthritis [letter]. Arthritis and Rheumatism, 1991, 34, 934–35.CrossRefGoogle ScholarPubMed
27.Croog, S. H., Levine, S., Testa, M. A., et al. The effects of antihypertensive therapy on the quality of life. New England Journal of Medicine, 1986, 314, 1657–64.CrossRefGoogle Scholar
28.Davidson, R. A.Source of funding and outcome of clinical trials. Journal of General Internal Medicine, 1986, 1, 155–58.CrossRefGoogle ScholarPubMed
29.Dickersin, K.Why register clinical trials? Revisited. Controlled Clinical Trials, 1992, 13, 170–77.CrossRefGoogle ScholarPubMed
30.Dickersin, K., & Garcia-Lopez, F.Regulatory process affects clinical trial registration in Spain. Controlled Clinical Trials, 1992, 13, 507–12.CrossRefGoogle Scholar
31.Dickersin, K., Min, Y-I., & Meinert, C. L.Factors influencing publication of research results: Follow-up of applications submitted to two institutional review boards. Journal of the American Medical Association, 1992, 267, 374–78.CrossRefGoogle ScholarPubMed
32.Dieppe, P. A., Frankel, S. J., & Toth, B.Is research into the treatment of osteoarthritis with non-steroidal anti-inflammatory drugs misdirected? Lancet, 1993, 341, 353–54.CrossRefGoogle ScholarPubMed
33.Dyer, C.GMC finds GPs guilty of fraud. British Medical Journal, 1994, 308, 1122.CrossRefGoogle ScholarPubMed
34.Easterbrook, P. J., Berlin, J. A., Gopalan, R., & Matthews, D. R.Publication bias in clinical research. Lancet, 1991, 337, 867–72.CrossRefGoogle ScholarPubMed
35.Epstein, W. V., & Criswell, L. A.Auranofin, methotrexate, but no placebo: Comment on the article by Williams et al. [letter]. Arthritis and Rheumatism, 1992, 35, 1406.CrossRefGoogle ScholarPubMed
36.Evidence-Based Medicine Working Group. Evidence-based medicine: A new approach to teaching the practice of medicine. Journal of the American Medical Association, 1992, 268, 2420–25.CrossRefGoogle Scholar
37.Farkouh, M. E., Lang, J. D., & Sackett, D. L.Thrombolytic agents: The science of the art of choosing the better treatment [editorial]. Annals of Internal Medicine, 1994, 120, 886–88.CrossRefGoogle ScholarPubMed
38.FDA Division of Neuropharmacological Drug Products, O. o. N. D. E. Tacrine as a treatment for Alzheimer’s dementia: An interim report from the FDA. New England Journal of Medicine, 1991, 324, 349–52.Google Scholar
39.F-D-C Reports Inc. FDA advisory committee defers decision on IMREG-1. The Blue Sheet, 11 23, 1988, 31, 2–3.Google Scholar
40.F-D-C Reports Inc. FIAU investigators receive FDA ‘warning letters.’ The Blue Sheet, 1994, 337, 11–12.Google Scholar
41.F-D-C Reports Inc. HRG suing FDA for FIAU study records, data from other discontinued drug clinical trials. The Blue Sheet, 1994, 37, 7.Google Scholar
42.F-D-C Reports Inc. IMREG-1 AIDS clinical trial; FDA inspection raises questions about patient selection, record-keeping. The Blue Sheet, 11 2, 1988, 31, 4–5.Google Scholar
43.Fisch, C., & Knoebel, S. B.Electrocardiographic findings in sertraline depression trials. Drug Investigation, 1992, 4, 305–12.CrossRefGoogle Scholar
44.Food and Drug Administration. Approved drug products with therapeutic equivalence, 12th ed.Washington, DC: Government Printing Office, 1992.Google Scholar
45.Food and Drug Administration. Guideline for the format and content of the clinical and statistical sections of an application. Center for Drug Evaluation and Research, Food and Drug Administration, 1988.Google Scholar
46.Food and Drug Administration. New drug and antibiotic regulations: Final rule. Federal Register, 1985, 50, 7452–519.Google Scholar
47.Forrow, L., Taylor, W. C., & Arnold, R. M.Absolutely relative: How research results are summarized can affect treatment decisions. American Journal of Medicine, 1992, 92, 121–24.CrossRefGoogle ScholarPubMed
48.Frick, M. H., Elo, O., & Haapa, K.Helsinki heart study: Primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia. New England Journal of Medicine, 1987, 317, 1237–45.CrossRefGoogle ScholarPubMed
49.Gardner, M. J.. & Bond, J.An exploratory study of statistical assessment papers published in the British Medical Journal. Journal of the American Medical Association, 1990, 263, 1355–57.CrossRefGoogle ScholarPubMed
51.Giannini, E. H., Brewer, E. J., Kuzmina, N., et al. Auranofin in the treatment of juvenile rheumatoid arthritis. Arthritis and Rheumatism, 1990, 33, 466–76.CrossRefGoogle ScholarPubMed
50.Giannini, E. H., & Brewer, E. J. Reply to letter. Arthritis and Rheumatism, 1991, 34.CrossRefGoogle Scholar
52.Gottlieb, M. S., Zackin, R. A., Fiala, M., et al. Response to treatment with the leukocytederived immunomodulator IMREG-1 in immunocompromised patients with AIDS related complex. Annals of Internal Medicine, 1991, 115, 84–91.CrossRefGoogle ScholarPubMed
53.Gøtzsche, P. C.Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Controlled Clinical Trials, 1989, 10, 31–56.CrossRefGoogle ScholarPubMed
54.Guyatt, G.Academic medicine and the pharmaceutical industry: A cautionary tale [editorial]. Canadian Medical Association Journal, 1994, 150, 951–53.Google ScholarPubMed
55.Guyatt, G. H., & Rennie, D.Users’ guides to the medical literature [editorial]. Journal of the American Medical Association, 1993, 270, 2096–97.CrossRefGoogle ScholarPubMed
56.Guyatt, G. H., Sackett, D. L., & Cook, D. J.Users’ guides to the medical literature, II: How to use an article about therapy or prevention. Journal of the American Medical Association, 1993, 270, 2598–601.CrossRefGoogle ScholarPubMed
57.Hardy, W. D.Foscarnet treatment of acyclovir-resistant herpes simplex virus infection in patients with acquired immunodeficiency syndrome: Preliminary results of a controlled, randomized, regimen-comparative trial. American Journal of Medicine, 1992, 92, 30S–35S.CrossRefGoogle ScholarPubMed
58.Haynes, R. B.Clinical review articles. British Medical Journal, 1991, 304, 330–31.CrossRefGoogle Scholar
59.Haynes, R. B., Mulrow, C. D., Huth, E. J., et al. More informative abstracts revisited. Annals of Internal Medicine, 1990, 113, 69–76.CrossRefGoogle ScholarPubMed
60.Hemminki, E.Quality of clinical trials: A concern for three decades. Methods in Information Medicine, 1982, 21, 81–85.Google ScholarPubMed
61.Hemminki, E.Quality of reports of clinical trials submitted by the drug industry to the Finnish and Swedish control authorities. European Journal of Clinical Pharmacology, 1981, 19, 157–65.CrossRefGoogle Scholar
62.Hemminki, E. Study of information submitted by drug companies to licensing authorities. British Medical Journal, 1980, 833–36.CrossRefGoogle Scholar
63.Herxheimer, A.Drug selection and information: Some recommendations from the World Health Organization. Journal of the Royal College of Physicians of London, 1993, 27, 384–85.Google ScholarPubMed
64.Herxheimer, A.How much drug in the tablet? Lancet, 1991, 337, 346–48.CrossRefGoogle ScholarPubMed
65.Hillman, A. L., Eisenberg, J. M., Pauly, M. V., et al. Avoiding bias in the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies. New England Journal of Medicine, 1991, 324, 1362–65.CrossRefGoogle ScholarPubMed
66.Hilts, P. J.Cigarette makers dispute reports on addictiveness. New York Times, 04 15, 1994, Al, A10–A11.Google Scholar
67.Hilts, P. J. Philip Morris blocked paper showing addiction, panel finds. New York Times, 04 1, 1994, A7.Google Scholar
68.Hilts, P. J. Scientists say Philip Morris withheld nicotine findings. New York Times, 04 29, 1994, Al, A7.Google Scholar
69.Hood, J., & William, B.More on sulfinpyrazone after myocardial infarction [editorial]. New England Journal of Medicine, 1982, 306, 988–89.CrossRefGoogle ScholarPubMed
70.Kassirer, J. P., & Angell, M.Financial conflicts of interest in biomedical research [letter to the editor]. New England Journal of Medicine, 1993, 329, 570–71.CrossRefGoogle ScholarPubMed
71.Kaufman, D.Cancer therapy and the randomized clinical trial. Cancer, 1993, 72, 2801–04.3.0.CO;2-N>CrossRefGoogle ScholarPubMed
72.Koshland, D. E. Jr., Simplicity and complexity in conflict of interest [editorial]. Science, 1993, 261, 11.CrossRefGoogle ScholarPubMed
73.Lauritsen, K., Havelund, T., Laursen, L. S., & Rask-Madsen, J. Withholding unfavorable results in drug company sponsored clinical trials [letter to the editor]. Lancet, 1987, 1091.CrossRefGoogle Scholar
74.Lee, K. L., Calliff, R. M., Simes, J., et al. Holding GUSTO up to the light. Annals of Internal Medicine, 1994, 120, 876–81.CrossRefGoogle ScholarPubMed
75.Lee, Y. J., Ellenberg, J. H., Hirtz, D. G., & Nelson, K. B.Analysis of clinical trials by treatment actually received: Is it really an option? Statistics in Medicine, 1991, 10, 1595–605.CrossRefGoogle ScholarPubMed
76.Lerner, M. Jury convicts Garfinkel of 5 fraud accounts. Minneapolis Star, 08 6, 1993, 1A.Google Scholar
77.Liberati, A.Publication bias and the editorial process [letter to the editor]. Journal of the American Medical Association, 1992, 267, 2891.CrossRefGoogle ScholarPubMed
78.Lock, S., & Wells, F.Fraud and misconduct in medical research. London: BMJ Publishing Group, 1993.Google Scholar
79.Lundberg, G. D.Statement by the International Committee of Medical Journal Editors on duplicate or redundant publication. Journal of the American Medical Association, 1993, 270, 2495.CrossRefGoogle Scholar
80.Lurie, P., & Wolfe, S. M.Regulation of benzodiazepine prescription [letter to the editor]. Journal of the American Medical Association, 1992, 268, 472–73.CrossRefGoogle ScholarPubMed
81.Meier, P.Anturane reinfarction trial [letter to the editor]. New England Journal of Medicine, 1981, 304, 730.Google ScholarPubMed
82.Meyers, S., & Janowitz, H. D.The “natural history” of ulcerative colitis: An analysis of the placebo response. Journal of Clinical Gastroenterology, 1989, 11, 33–37.CrossRefGoogle Scholar
83.Miller, R. The publication of commercially sponsored supplements [editorial]. Anesthesia and Analgesia, 1993, 77.CrossRefGoogle Scholar
84.Moher, D.Clinical trial registration: A call for its implementation in Canada. Canadian Medical Association, 1993, 149, 1657–58.Google Scholar
85.Moher, D., Dulberg, C. S., & Wells, G. A.Statistical power, sample size, and their reporting in randomized controlled trials. Journal of the American Medical Association, 1994, 272, 122–24.CrossRefGoogle ScholarPubMed
86.Mulrow, C. D.The medical review article: State of the science. Annals of Internal Medicine, 1987, 106, 485–88.CrossRefGoogle ScholarPubMed
87.Naylor, C. D., Chen, E., & Strauss, B.Measured enthusiasm: Does the method of reporting trial results alter perception of therapeutic effectiveness? Annals of Internal Medicine, 1992, 117, 916–21.CrossRefGoogle ScholarPubMed
88.Newman, T. B., Browner, W. S., & Hulley, S. B.The case against childhood cholesterol screening. Journal of the American Medical Association, 1990, 264, 3039–43.CrossRefGoogle ScholarPubMed
89.Nicholson, P. A.Information for drug trial participants [letter to the editor]. Lancet, 1987, 396.Google Scholar
90.Norman, C.Stanford inquiry casts doubt on 11 papers. Science, 1988, 242, 659–61.CrossRefGoogle ScholarPubMed
91.Office of the Inspector General. Promotion of prescription drugs through payments and gifts. Washington, DC: Department of Health and Human Services, 1991OEI–01–00480.Google Scholar
92.Oxman, A. D.Readers’guide for review articles: Why worry about methods? [editorial]. American College of Physicians Journal Club, 1991, A–12.Google Scholar
93.Oxman, A. D., & Guyatt, G. H.Validation of an index of the quality of review articles. Journal of Clinical Epidemiology, 1991, 44, 1271–78.CrossRefGoogle ScholarPubMed
94.Oxman, A. D., Guyatt, G. H., Singer, J., et al. Agreement among reviewers of review articles. Journal of Clinical Epidemiology, 1991, 44, 91–98.CrossRefGoogle ScholarPubMed
95.Pharmaceutical Manufacturers Association. Facts at a glance. Washington, DC: Pharmaceutical Manufacturers Association, 1992.Google Scholar
96.Polis, M. A. Design of a randomized controlled trial of foscarnet in patients with cytomegalovirus retinitis associated with acquired immunodeficiency syndrome. American Journal of Medicine, 1992, 22S–25S.CrossRefGoogle Scholar
97.Public Health Service. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register, 03 28, 1994, 59, 14508–13.Google Scholar
98.Raju, T. N. K., Langenberg, P., Sen, A., & Aldana, O.How much ‘better’ is good enough? The magnitude of treatment effect in clinical trials. American Journal of the Diseased Child, 1992, 146, 407–11.CrossRefGoogle ScholarPubMed
99.Rakel, R. E. Antianxiety agents: How to use them, what to avoid. Consultant, 1989, 75–85.Google Scholar
100.Ray, W. A., Griffin, M. R., & Avorn, J.Evaluating drugs after their approval for clinical use [editorial]. New England Journal of Medicine, 1993, 329, 2029–32.CrossRefGoogle ScholarPubMed
101.Rennie, D.Accountability, audit, and reverence for the publication process [editorial]. Journal of the American Medical Association, 1993, 270, 495–96.CrossRefGoogle ScholarPubMed
102.Rennie, D.Authorship! Authorship! Guests, ghosts, grafters, and the two-sided coin [editorial]. Journal of the American Medical Association, 1994, 271, 469–71.CrossRefGoogle ScholarPubMed
103.Rennie, D.Breast cancer: How to mishandle misconduct. Journal of the American Medical Association, 1994, 271, 1205–07.CrossRefGoogle ScholarPubMed
104.Rennie, D.Editors and auditors [editorial]. Journal of the American Medical Association, 1989, 261, 2543–45.CrossRefGoogle ScholarPubMed
105.Rennie, D. (ed.) Guarding the guardians: Research on editorial peer review. Journal of the American Medical Association, 1990, 263, 1317–444.CrossRefGoogle Scholar
106.Rennie, D.The Second International Congress on Peer Review. Journal of the American Medical Association, 1994, 272, 91–173.CrossRefGoogle ScholarPubMed
107.Rennie, D., & Bero, L. A.Throw it away Sam: The controlled circulation journals. Council of Biological Editors' Views, 1990, 13, 31–35.Google Scholar
108.Rennie, D., & Flanagin, A.Publication bias: The triumph of hope over experience [editorial]. Journal of the American Medical Association, 1992, 267, 411–12.CrossRefGoogle ScholarPubMed
109.Review policy for supplement. Cardiovascular Drugs and Therapy, 1993, 7, 493.CrossRefGoogle Scholar
110.Ridker, P. M., O'Donnell, C. J., Marder, V. J., & Hennekens, C. H.A response to ‘holding GUSTO up to the light.’ Annals of Internal Medicine, 1994, 120, 882–85.CrossRefGoogle Scholar
111.Ridker, P. M., O'Donnell, C.Marder, V. J., & Hennekens, C. H.Large scale trials of thrombolytic therapy for acute myocardial infarction: GISSI–2, ISIS–3, GUSTO–1. Annals of Internal Medicine, 1993, 119, 530–32.CrossRefGoogle ScholarPubMed
112.Rochon, P. A., Gurwitz, J. H., Cheung, C. M., et al. Evaluating the quality of articles published in journal supplements compared with the quality of those published in the parent journal. Journal of the American Medical Association, 1994, 272, 108–13.CrossRefGoogle ScholarPubMed
113.Rochon, P. A., Gurwitz, J. H., Simms, R. W., et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Archives of Internal Medicine, 1994, 154, 1587–63.CrossRefGoogle ScholarPubMed
114.Roizon, M. F., (ed). Lessons learned from a phase IV study of propofol: Analysis of data of over 25,000 patients. Anesthesia and Analgesia, 1993, 77, S1–S50.Google Scholar
115.Rothman, K. J.Conflict of interest [editorial]. Journal of the American Medical Association, 1993, 269, 2782–84.CrossRefGoogle ScholarPubMed
116.Rothman, K. J., & Michels, K. B.The continuing unethical use of placebo controls [editorial]. New England Journal of Medicine, 1994, 331, 394–98.CrossRefGoogle ScholarPubMed
117.Sackett, D. L., & Gent, M.Controversy in counting and attributing events in clinical trials [editorial]. New England Journal of Medicine, 1979, 301, 1410–12.CrossRefGoogle ScholarPubMed
118.Schulz, K. F., Chalmers, I., Grimes, D. A., & Altman, D. G.Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. Journal of the American Medical Association, 1994, 272, 125–28.CrossRefGoogle ScholarPubMed
119.Schwarz, R. P. Jr., Maintaining integrity and credibility in industry-sponsored clinical research. Controlled Clinical Trials, 1991, 12, 753–60.CrossRefGoogle ScholarPubMed
120.Shapiro, M. F. Data audit in investigational drug trials and their implications for detection of misconduct in science. In Lock, S. & Wells, F., (eds.), Fraud and misconduct in medical research, London: BMJ Publishing Group, 1993, 128–41.Google Scholar
121.Simes, R. J.The case for an international registry of clinical trials. Journal of Clinical Oncology, 1986, 4, 1529–41.CrossRefGoogle ScholarPubMed
122.Smith, J. L., & ACG Committee on FDA-Related Matters. Placebos in clinical trials of peptic ulcer. American Journal of Gastroenterology, 1989, 84, 469–74.Google ScholarPubMed
123. Softening the blow of bacterial meningitis. Emergency Medicine, 1989, 45–48.Google Scholar
124.Special Committee on Aging. Prescription drug prices: Are we getting our money’s worth? Washington, DC: United States Senate, 1989, a Majority Staff Report Serial No. 101-D.Google Scholar
125.Special Committee on Aging. The drug manufacturing industry: A prescription for profits. Washington, DC: United States Senate, 1991, Staff Report Serial No. 102-F.Google Scholar
126.Summers, W. K., Majovski, L. V., Marsh, G. M., et al. Oral tetrahydroaminoacridine in long-term treatment of senile dementia. New England Journal of Medicine, 1986, 315, 1241–55.CrossRefGoogle ScholarPubMed
127.Taylor, S. H., (ed.). A symposium: A new cardiovascular agent with a unique profile. American Journal of Cardiology, 1986, 58, 1E–44E.CrossRefGoogle Scholar
128.Temple, R.Difficulties in evaluating positive control trials. Biopharmaceutical Section Proceedings of the American Statistical Association, 1983, 1–7.Google Scholar
129.Temple, R.Government viewpoint of clinical trials. Williamsburg, VA: The Drug Information Association Workshop. 1981, 10–17.Google Scholar
130.Temple, R., & Pledger, G. W.The FDA's critique of the anturane reinfarction trial [special report]. New England Journal of Medicine, 1980, 303, 1488–92.CrossRefGoogle ScholarPubMed
131.The Anturane Reinfarction Trial Research Group. Sulfinpyrazone in the prevention of sudden death after myocardial infarction. New England Journal of Medicine, 1980, 302, 250–56.CrossRefGoogle Scholar
132.The Boston Consulting Group. Executive summary. In The contribution of pharmaceutical companies: What's at stake for America. Boston, MA: The Boston Consulting Group, Inc., 1993.Google Scholar
133.The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. New England Journal of Medicine, 1993, 329, 673–82.CrossRefGoogle Scholar
134.Treatment of Mild Hypertension Research Group. A randomized, placebo-controlled trial of a nutritional-hygienic regimen along with various drug monotherapies. Archives of Internal Medicine, 1991, 151, 1413–23.CrossRefGoogle Scholar
135.Turner, J. A., Deyo, R. A., Loeser, J. D., et al. The importance of placebo effects in pain treatment and research [review]. Journal of the American Medical Association, 1994, 271, 1609–14.CrossRefGoogle Scholar
136.Tversky, A., & Kahneman, D.The framing of decisions and the psychology of choice. Science, 1981, 211, 453–58.CrossRefGoogle ScholarPubMed
137.Waller, P. C., Wood, S. M., Langman, M. J. S., et al. Review of company postmarketing surveillance studies. British Medical Journal, 1992, 304, 1470–72.CrossRefGoogle ScholarPubMed
138.Wassertheil-Smoller, S., Blaufox, M. D., Oberman, A., et al. Effect of antihypertensives on sexual function and quality of life: The TAIM Study. Annals of Internal Medicine, 1991, 114, 613–20.CrossRefGoogle ScholarPubMed
139.Weintraub, M.Regulation of benzodiazepine prescription [letter to the editor]. Journal of the American Medical Association, 1992, 268, 474.Google Scholar
140.Weintraub, M., Singh, S., Byrne, L., et al. Consequences of the 1989 New York State triplicate benzodiazepine prescription regulations. Journal of the American Medical Association, 1991, 266, 2392–97.CrossRefGoogle ScholarPubMed
141.Weiss, R. B., Vogelzang, N. J., Peterson, B. A., et al. A successful system of scientific data audits for clinical trials: A report from the cancer and leukemia group B. Journal of the American Medical Association, 1993, 270, 459–64.CrossRefGoogle ScholarPubMed
142.Williams, H. J., Ward, J. R., Reading, J. C., et al. Comparison of auranofin, methotrexate, and the combination of both in the treatment of rheumatoid arthritis. Arthritis and Rheumatism, 1992, 35, 259–69.CrossRefGoogle ScholarPubMed
143.Winer, N., Carter, C. H., & Eddy, H.Effects of pindolol and methyldopa on blood pressure and plasma norepinephrine. American Heart Journal, 1982, 104, 425–31.CrossRefGoogle ScholarPubMed
144.World Health Organization. 18th European Symposium on Clinical Pharmacological Evaluation in Drug Control, Bad Neuenahr, December 10–13,1991, World Health Organization, 1993EUR/ICP/DSE 173.Google Scholar
145.World Health Organization. The use of essential drugs, WHO Technical Report Series 825. Geneva: World Health Organization, 1992.Google Scholar
146.Wyllie, E., Pippenger, C. E., & Rothner, A. D.Increased seizure frequency with generic primidone. Journal of the American Medical Association, 1987, 258, 1216–17.CrossRefGoogle ScholarPubMed