Reporting the study populations of clinical trials clear transmission or static on the line?

Journal of Clinical Epidemiology

Volumn 53, Issue 10, 2000, Pages 973-979

  Shapiro, Stanley H ^a   Weijer, Charles ^b   Freedman, Benjamin ^c  

^a MCGILL UNIVERSITY   (Canada)

^b DALHOUSIE UNIVERSITY   (Canada)

^c MCGILL UNIVERSITY   (Canada)

Author keywords

Clinical trials (methods); Clinical trials (standards); Eligibility determination; Periodicals (standards)

Indexed keywords

ACCURACY; ARTICLE; BIOSTATISTICS; CLINICAL PROTOCOL; CLINICAL TRIAL; HUMAN; MEDICAL RESEARCH; METHODOLOGY; PATIENT SELECTION; POPULATION; PRIORITY JOURNAL; PUBLICATION; STANDARD;

CLINICAL TRIALS; ETHICS, MEDICAL; HUMAN; PATIENT SELECTION; PERIODICALS; SUPPORT, NON-U.S. GOV'T;

EID: 0033807189     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0895-4356(00)00227-4     Document Type: Article

References (52)

1. Luetke-Stahlman B. Communication games. Perspectives for Teachers of the Hearing Impaired. 5:1987;9-11.
2. World Medical Association. Declaration of Helsinki [1964, as revised 1996].
3. Dingell J.D. Misconduct in medical research. N Engl J Med. 328:1993;1610-1615.
4. Dickerson K. The existence of publication bias and risk factors for its occurrence. JAMA. 263:1990;1385-1389.
5. Chalmers I. Underreporting research is scientific misconduct. JAMA. 263:1990;1405-1408.
6. Dickerson K., Berlin J.A. Meta-analysis. state-of-the science Epidemiol Rev. 14:1992;154-176.
7. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med. 324:1991;424-428.
8. Simon R., Wittes R.E. Methodologic guidelines for reports of clinical trials. Cancer Treat Rep. 69:1985;1-3.
9. Zelen M. Guidelines for publishing papers on cancer clinical trials. responsibilities of editors and authors J Clin Oncol. 1:1983;164-169.
10. Bailar J.C., Mosteller F. Guidelines for statistical reporting in articles for medical journals. Ann Intern Med. 108:1988;266-273.
11. Chalmers T.C., Smith H., Balckburn B., Silverman B., Schroeder B., Reitman D., Ambroz A. A method for assessing the quality of randomized control trial. Control Clin Trials. 2:1981;31-49.
12. Zola P., Volpe T., Castelli G.et al. Is the published literature a reliable guide for deciding between alternative treatments for patients with early cervical cancer? Int J Radiation Oncology Biol Phys. 16:1989;785-797.
13. Liberati A., Himel H.N., Chalmers T.C. A quality assessment of randomized controlled trials of primary treatment of breast cancer. J Clin Oncol. 4:1986;942-951.
14. DerSimonian R., Charette L.J., McPeek B., Mosteller F. Reporting on methods in clinical trials. N Engl J Med. 306:1982;1332-1337.
15. Emerson J.D., McPeek B., Mosteller F. Reporting clinical trials in general surgical journals. Surgery. 95:1984;572-579.
16. Friedman M.A. The clinical announcement policy of the National Cancer Institute. Williams C.J. Introducing New Treatments for Cancer. Practical, Ethical and Legal Problems:1992;413-419 John Wiley & Sons, New York.
17. Wittes R.E. Of Clinical Alerts and peer review. J Natl Cancer Inst. 80:1988;984-985.
18. National Cancer Institute. Clinical Alert. Bethesda, MD: National Cancer Institute. May 16, 1988.
19. Fuks A., Weijer C., Freedman B., Shaprio S., Skrutkowski M., Riaz A. A study in contrasts. eligibility criteria in a twenty-year sample of NSABP and POG clinical trials J Clin Epidemiol. 51:1998;69-79.
20. National Institute of Neurological Disorders and Stroke (NINDS). February 26, 1991. Benefit of carotid endarterectomy for patients with high-grade stenosis of the internal carotid artery. Available: http://www . nlm.nih.gov/databases/alerts/clinical_alerts.html . Accessed July 3, 2000.
21. National Institute of Child Health and Human Development (NICHD). January 18, 1991. Results of the NICHD clinical trial of the efficacy of intravenous immunoglobulin (IVIG) for the prophylaxis of serious bacterial infections in symptomatic HIV-infected children. Available: http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html . Accessed July 3, 2000.
22. National Eye Institute (NEI). October 29, 1991. Findings of the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. Available: http://www . nlm.nih.gov/databases/alerts/clinical_alerts.html . Accessed July 3, 2000.
23. National Institute of Allergy and Infectious Diseases (NIAID). October 21, 1991. Important therapeutic information on prevention of recurrent pneumocystis carinii pneumonia in persons with AIDS. Available: http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html . Accessed July 3, 2000.
24. National Institute of Allergy and Infectious Diseases (NIAID). February 1, 1993. Important therapeutic information on treatment of HIV infection in HIV-infected patients who are intolerant of or have failed zidovudine therapy. Available: http://www.nlm.nih.gov/databases/alerts/ clinical_alerts.html . Accessed July 3, 2000.
25. National Heart, Lung and Blood Institute (NHLBI). July 31, 1991. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. Available: http://www.nlm . nih.gov/databases/alerts/clinical_alerts.html . Accessed July 3, 2000.
26. National Heart, Lung and Blood Institute (NHLBI). National Institute of Aging (NIA). June 26, 1991. Results of the NHLBI and NIA clinical trial of the efficacy of antihypertensive treatment for isolated systolic hypertension in those aged 60 years and older. Available: http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html . Accessed July 3, 2000.
27. National Eye Institute (NEI). February 28, 1992. Findings from the Optic Neuritis Treatment Trial. Available: http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html . Accessed July 3, 2000.
28. North American Symptomatic Carotid Endarterectomy Trial. methods, patient characteristics and progress Stroke. 22:1991;711-720.
29. Studies of Ocular Complications of AIDS (SOCA) Research Group in collaboration with the AIDS Clinical Trials Group (ACTG). Studies of Ocular Complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. Control Clin Trials 1992;13:22-39.
30. Studies of Left Ventricular Dysfunction (SOLVD) - Rationale, design and methods. two trials that evaluate the effect of enalapril in patients with reduced ejection fraction Am J Cardiol. 66:1990;315-322.
31. Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension. J Clin Epidemiol. 41:1988;1197-1208.
32. Clearly P.A., Beck R.W., Anderson M.M., the Optic Neuritis Study Group Design, methods and conduct of the Optic Neuritis Treatment Trial. Control Clin Trials. 14:1993;123-142.
33. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 325:1991;445-453.
34. Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic human immunodeficiency virus infection. N Engl J Med. 325:1991;73-80.
35. Mortality in patients with the Acquired Immunodeficiency Syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. N Engl J Med. 326:1992;213-220.
36. Hardy W.D., Feinberg J., Finkelstein D.M., for the AIDS Clinical Trial Group A controlled trial of trimethoprim-sulfamethoxazole or aerosolozed pentamidine for secondary prophylaxis of Pneumocystis Carinii pneumonia in patients with the Acquired Immunodeficiency Syndrome. N Engl J Med. 327:1992;1842-1848.
37. Abrams D.I., Goldman A.I., Launer C., the Terry Beirn Community Program for Clinical Research on A.I.D.S. A comparative trial of didanosine or zalcitabine after treatment with zidovudine in patients with human immunodeficiency virus infection. N Engl J Med. 330:1994;657-662.
38. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med. 325:1991;293-302.
39. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. final results of the Systolic Hypertension in the Elderly Program (SHEP) JAMA. 265:1991;3255-3264.
40. Beck R.W., Cleary P.A., Anderson M.M., the Optic Neuritis Study Group A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. N Engl J Med. 326:1992;581-588.
41. Lessell S. Corticosteroid treatment of acute optic neuritis. N Engl J Med. 326:1992;634-635.
42. Macdonald J.S. Sometimes a great notion. J Natl Cancer Inst. 82:1990;102-104.
43. Wittenberg C.K. Clinical Alerts. Broder discusses pros and cons on record J Natl Cancer Inst. 82:1990;186-187.
44. DeVita V.T. Is a mechanism such as the NCI's Clinical Alert ever an appropriate alternative to journal peer review? DeVita V., Hellman S., Rosenberg S. Important Adv Oncol. 1991;241-253 J.B. Lippincott, Philadelphia.
45. Vanchieri C. Clinical Alert stimulates changes in practice. J Natl Cancer Inst. 80:1988;1185-1187.
46. Begg C.B., Engstrom P.F. Eligibility and extrapolation in cancer clinical trials. J Clin Oncol. 5:1987;962-968.
47. Glass K.G. Towards a duty to report clinical trials accurately. the Clinical Alert and beyond J Law Med Ethics. 22:1994;327-338.
48. Hellman S. Clinical Alert: a poor idea prematurely used. In: DeVita V, Hellman S, Rosenberg S, editors. Important Adv Oncol Philadelphia: J.B. Lippincott 1991:255-7.
49. Yusuf S., Collins R., Peto R. Why do we need large, simple randomized trials? Stat Med. 3:1984;409-420.
50. Freedman B., Shapiro S. Ethics and statistics in clinical research. towards a more comprehensive examination J Stat Planning Inference. 42:1994;223-240.
51. Weijer C., Shapiro S., Fuks A., Glass K., Skrutkowska M. Monitoring clinical research. an obligation unfulfilled Can Med Assoc J. 152:1995;1973-1980.
52. Begg C., Cho M., Eastwood S., Horton R., Mohr D., Olkin I., Pitkin R., Rennie D., Schulz K., Simel D., Stroup D. Improving the quality of reporting of randomized controlled trials. JAMA. 276:1996;637-649.