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American College of Surgeons: Continuous Quality Improvement

CQI > Surgical Research Committee > 2009 Clinical Trials Methods Course

2009 Clinical Trials Methods Course

Complete Reference List

  1. Adelman AG, Cohen EA, Kimball BP, et al. A comparison of directional atherectomy with balloon angioplasty for lesions of the left anterior descending coronary artery. N Engl J Med 1993; 329:228-233.


  2. Ariyan S. Of mice and men: honesty and integrity in medicine. Ann Surg 1994; 220:745-750.


  3. American Journal of Surgery, American Surgeon, Annals of Surgery et al. Consensus Statement: scientific data from commercially sponsored clinical trials: investigators’ responsibilities and rights.


  4. American Journal of Surgery, American Surgeon, Annals of Surgery et al. Consensus Statement on Submission and Publication of Manuscripts 2001; 8:382-383.


  5. Arozullah AM, Daley J, Henderson WG, Khuri SF. Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. Ann Surg 2000; 232:242-253.


  6. Bailey KR. Detecting fabrication of data in a multicenter collaborative animal study. Cont Clin Trials 1991; 12:741-752.


  7. Barber JA, Thompson SG. Analysis and interpretation of cost data in randomized controlled trials: review of published studies. BMJ 1998; 317:1195-1200.


  8. Barnett HJM, Taylor D.W., Eliasziw M, et al. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. N Engl J Med 1998; 339:1415-1425.


  9. Baue AE. Reflections of a Former Editor. Arch/Surg. 1993; 123:1302-1314.


  10. Berg C, Cho M, Eastwood S, Horton R, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996 Aug 28; 276(8):637-639.


  11. Berger VW, Exner DV. Detecting selection bias in randomized clinical trials. Controlled Clin Trials 1999; 20:319-327.


  12. Birkmeyer JD. Outcomes research and surgeons. Surgery 1998; 124:477-483.


  13. Blumenstein BA, James KE, Lind BK, Mitchell HE. Functions and organization of coordinating centers for multicenter studies. Cont Clin Trials 1995; 16:4S-29S.


  14. Bonchek LI. Are randomized trials appropriate for evaluating new operations? N Engl J Med 1979; 301:44-45.


  15. Brody BA. The Ethics of Biomedical Research: an international perspective. New York: Oxford University Press 1998.


  16. Brown BW, Jr. Statistical controversies in the design of clinical trials. Cont Clin Trials 1980; 1:13-27.


  17. Browner WS, Newman TB, Cummins SR, and Hulley SB. Getting ready to estimate sample size: hypotheses and underlying principles. in Hulley SB: (ed): Designing Clinical Research. Baltimore, Williams & Wilkins; 1988.


  18. Browner WS, Black D, Newman TB, and Hulley SB. Estimating sample, size and power. in Hulley SB: (ed): Designing Clinical Research. Baltimore, Williams & Wilkins; 1988.


  19. Brubaker L, et al. Abdominal Sacrocolpopexy with Burch Colposuspension to Reduce Urinary Stress Incontinence. NEJM 2006;354(15):1557-66.


  20. Bryant DM, Sanders DW, Coles CP, et. al. Selection of outcome measures for patients with hip fracture. J Orthop Trauma 2009;23:434-41.


  21. Buyse M, George SL, Evans S, et al. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med 1999; 18:3435-3451.


  22. Byar DP. Assessing apparent treatment-covariate interactions in randomized clinical trials. Stat Med 1985; 4:255-263.


  23. Canner PL, Krol WFFSA. External quality control programs. Cont Clin Trials 1983; 4:441-466.


  24. Chalmers T. Unbiased, relevant, and reliable assessments in health care. BMJ 1998; 317:1167-1168.


  25. Chalmers TC. Bias in treatment assignment in controlled clinical trials. N Engl J Med 1983; 309:1358-1361.


  26. Chalmers TC. Randomization of the first patient. Med Clin NA 1997.


  27. Clarke MJ. Ovarian ablation in breast cancer, 1896 to 1998: milestones along hierarchy of evidence from case report to Cochrane review. BMJ 1998; 317:1246-1248.


  28. Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004;350(20):2050-9


  29. Cobb LA, Thomas GI, Dillard DH, Merendino KA, Bruce RA. An evaluation of internal mammary artery ligation by a double blind technique. N Engl J Med 1959; 260:1115-1118.


  30. Code of Federal Regulations- ICH Guideline_ Good Clinical Practice 21CFR Parts 50, 54, 56. http://wwwgmpublications.com


  31. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd edition Hillsdale, NJ. Lawrence Erlbaum Associates, Publishers, 1988.


  32. Collins R, MacMahon S. Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials. Lancet 2001; 357:373-380.


  33. Committee on Publication Ethics. Guidelines on good publication Practice. in: The COPE Report 2001.


  34. Committee on Strategies for Small-Number-Participant Clinical Research Trials OHSP. Small clinical trials: issues and challenges. Washington, D.C.: Institute of Medicine, 2001.


  35. Consensus Statement on Surgery Journal Authorship. 2005.


  36. Corbett F, Oldham J, Lilford R. Offering patients entry in clinical trials: preliminary study of the views of prospective participants. J Med Ethics 1996; 22:227-231.


  37. Coultas D: Ethical considerations in the interpretation and communication of clinical trial results. Proc Am Thorac Soc. 2007 May;4(2):194-8.


  38. Cummings SR, Browner WS, Hulley SB. Conceiving the research question. In: Hulley SB, Cummings SR, editors. Designing Clinical Research. Baltimore: Williams and Wilkins, 2001:17-23.


  39. Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, Horton R, et al. Sponsorship, authorship, and accountability. N Engl J Med 2001; 345:825-827.


  40. Davis CE. Secondary endpoints can be validly analyzed, even if the primary endpoint does not provide clear statistical significance. Controlled Clinical Trials 1997; 18:557-560.


  41. De Angelis C, et al. Clinical trials registration: A Statement from the International Committee of Medical Journal Editors. NEJM 2004 Sept 16;351(12):1250-1251.


  42. DerSimonian R, Levine RJ. Resolving discrepancies between a meta-analysis and a subsequent large controlled trial. JAMA 1999;282:664-670.


  43. Doll R. Controlled trials: the 1948 watershed. BMJ 1998;317:1217-1220.


  44. Donner A. Approaches to sample size estimation in the design of clinical trials – a review. Statistics in Medicine 1984; 3:199-214.


  45. Doyal L, Tobias J. Informed consent in medical research. BMJ 1998; 316:1000-1005.


  46. Drummond MF, Stoddard GLTGW, editors. Methods for the Economic Evaluation of Health Care Programmes. Oxford, Oxford University Press, 1986.


  47. Early Breast Cancer Trialists' Collaborative Group. Effects of radiotherapy and surgery in early breast cancer. An overview of the randomized trials. N Engl J Med 1995; 333:1444-1455.


  48. Editorial. From research to practice. Lancet 1994; 344:417-418.


  49. Edwards SJL, Lilford RJ, Hewison J. The ethics of randomized controlled trials from the perspectives of patients, the public, and healthcare professionals. BMJ 1998; 317:1209-1212.


  50. Emanuel EJ, Miller FG. The ethics of placebo-controlled trials - a middle ground. N Engl J Med 2001; 345:915-919.


  51. Engler RL, Cavell JW, Friedman PJ et al. Misrepresentation and responsibility in medical research. N Engl J Med, 1987; 317:1383-1389.


  52. Executive Committee for the Asymtomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA 1995; 273:1421-1428.


  53. Farrakhyar F, Chu R, Whitlock R, Thabane L. A systematic review of the quality of publications reporting coronary artery bypass grafting trials. Can J Surg 2007; 50(4):266-277.


  54. Farrell B. Efficient management of randomized controlled trials: nature or nurture. BMJ 1998; 317:1236-1239.


  55. Featherstone K, Donovan JL. Random allocation or allocation at random? Patients' perspectives of participation in a randomized clinical trial. BMJ 1998; 317:1177-1180.


  56. Feinstein AR. Problems, pitfalls and opportunities in long-term randomized trials. Arzneim-Forsch 1989; 39.


  57. Feynman RP. Cargo cult science. In: Anonymous "Surely You're Joking, Mr. Feynman! ” New York: W.W.Norton & Co., 1985; 338-346.


  58. Fisher B, Bauer M, Margolese R, Poisson R, et al. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 1985; 312(11):665-673.


  59. Fleiss JL. The design and analysis of clinical experiments. New York, John Wiley and Son, 1986.


  60. Foster D, Cook D, Granton J, Steinberg M, Marshall J. Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit. Crit Care Med 2000; 28:867-871.


  61. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317:141-145.


  62. Freeman TB, Vawter D.E., Leaverton PE, Godbold JH, Hauser RA, Goetz CG, et al. Use of placebo controlled trials of a cellular-based therapy for Parkinson's disease. N Engl J Med 1999; 341:988-992.


  63. Friedman LM, Furberg CD, DeMets DL. Data Collection and Quality Control. In: Fundamentals of Clinical Trials, Third Edition, Springer-Verlag, New York, 1998.


  64. Fuks A, Weijer C, Freedman B. et al. A study in contrasts: eligibility criteria in a twenty-year sample of NSABP and POG clinical trials, J Clin Epidemiol 1998; 51(2):69-79.


  65. George SL. The required size and length of a clinical trial. In: Buyse ME, Staquet MJ, Sylvester RJ, editors. Cancer Clinical Trials. Oxford: Oxford University Press, 1984:287-310.


  66. Goligher J.C., Feather D, Hall R, et al. Several standard elective operations for duodenal ulcer: ten to sixteen year clinical results. Ann Surg 1979; 189:18.


  67. Good Clinical Practices (E6) and Clinical Safety Data Management (E2A): ICH Guidelines as adopted by the FDA.


  68. Good Clinical Practices: Code of Federal Regulations, parts 50,54,56,312,314.


  69. Goodman SN, Berlin JA. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med 1994; 121:200-206.


  70. Goodwin PF, Leszcz M, Quirt G, Koopmans J, Arnold A, Dohan E, et al. Lessons learned from enrollment in the BEST study - a multicenter randomized trial of group psychosocial support in metastatic breast cancer. J.Clin.Epidemiol 2000; 53:47-55.


  71. Grant AM, Wileman SM, Ramsay CR, Mowat NA, Krukowski ZH, Heading RC, Thursz MR, Campbell MK, REFLUX Trial Group. Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomized trial. BMJ 2008; 337;a2664 (9 pages).


  72. Green SB. Hypothesis testing in clinical trials. Hematol Oncol Cl NA 2000; 14:785


  73. Gross CP, Mallory, R, Helat A, et al. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Ann Intern Med 2002; 137:10-16.


  74. Guidelines on Good Publication Practice. IN: The COPE Report 2001.


  75. Halbert JA, Silagy CA, Finucane P, Withers RT, Hamdorf PA. Recruitment of older adults for a randomized controlled trial of exercise advice in a general practice setting. J Am Geriatric Soc 1999; 47:477-481.


  76. Hall GM. The structure of a scientific paper. London British Medical Journal 1997.


  77. Hall JC, Platell C, Hall JL. Surgery on trial: an account of clinical trials evaluating operations. Surgery 1998; 124:22-27.


  78. Halpern SD, Karlawish JH, Berlin JA. The continuing unethical conducts of underpowered clinical trials. JAMA 2002; 288:258-362.


  79. Hellman S, Hellman DS. Of mice but not men. Problems of the randomized clinical trial. N Engl J Med 1991; 324:1585-1591.


  80. Helms RW, Fitzmartin R, Fillow PJ, et al. Metrics and best practices in clinical data management: conclusions of DIA roundtable workshop, Drug Information Journal 2001; 35:681-694.


  81. Hobson RW. Role of carotid endarterectomy in asymptomatic caroid stenosis: a Veterans Administration Cooperative Study. Stroke 1986; 17:534-539.


  82. Hobson RW. Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. N.Engl.J.Med. 1993; 328:221-227.


  83. Horn SD. Performance measures and clinical outcomes. JAMA 2006; 296 (22):2731-32.


  84. Hosking JD, Newhouse MM, Bagniewsha A, Hawkins BS. Data collection and transcription. Cont Clin Trials 1995; 116 (supplement #2):66S-103S.


  85. Houle TT, Penzien DB, Houle CK. Statistical power and sample size estimation for headache research: An overview and power calculation tools. Headache 2005; 45:414-418.


  86. Howard G, Chambless LE, Kronmal RA. Assessing differences in clinical trials comparing surgical vs. nonsurgical therapy. Using common (statistical) sense. JAMA 1997; 278:1432-1436.


  87. Hsieh FY. Sample size tables for logistic regression. Statistics in Medicine 1989; 8:795-802.


  88. Hulley SB, Cummings SR. Planning the measurements: precision and accuracy. In: Hulley SB, Cummings SR, editors. Designing Clinical Research. Baltimore: Williams and Wilkins, 1988; 31-41.


  89. Hulley SB, Newman TB, Cummings SR. Getting started: the anatomy and physiology of research. In: Hulley SB, Cummings SR, editors. Designing Clinical Research. Baltimore: Williams and Wilkins, 2001; 3-15.


  90. Hulley SB, Feigal D, Martin M, Cummings SR. Designing a new study: IV. Experiments. In: Hulley SB, Cummings SR, editors. Designing Clinical Research. Baltimore: Williams & Wilkins, 1988:


  91. Ioannidis JPA, Cappelleri JC, Lau J. Issues in comparisons between meta-analyses and large trials. JAMA 1998; 279:1089-1093.


  92. Ioannidis JPA, Lau J. Can quality of clinical trials and meta-analyses be quantified? Lancet 1998; 352:590.


  93. Iezzoni LI, editor. Risk Adjustment for Measuring Health Care Outcomes. Ann Arbor, MI: Health Administration Press, 1997.


  94. Itani KM and McCullough LB. Randomized clinical surgical trials: are they really necessary? Asian J of Surg. 2004 Jul; 27(3):1-6.


  95. Jacobs JR, Pajak TF, Weymuller E et al. Development of surgical quality-control mechanisms in large-scale prospective trials: Head and Neck Intergroup report. Head Neck, 1991; 13:28-32.


  96. Jacquier I, Boutron I, Moher D, Roy C, Ravaud P. The reporting of randomized clinical trials using a surgical intervention is in need of immediate review: A systematic review. Annals of Surgery, 22006; 244(5):677-683.


  97. Johnson AG. Removing bias in surgical trials. BMJ 1997; 314:916-917.


  98. Johnstone AJ, John TG, Thompson AM, Dixon JM, Charles M. Wound compression pads are of no value after local anaesthetic breast biopsy. Ann Royal Coll Surg Eng 1991; 73:303-304.


  99. Julius S, Zariffa N. The ABC of pharmaceutical trial design: some basic principles, Pharmaceut Statist 2002; 1:45-53.


  100. Kaptchuk TJ. Powerful placebo: the dark side of the randomized controlled trial. Lancet 1998; 351:1722-1725.


  101. Kassirer JP, Angell M. On authorship and acknowledgments. N Engl J Med 1991; 325:1510-1512.


  102. Kelloff GJ, Sigman CC. New science-based endpoints to accelerate oncology drug development. Eur J Cancer 2005;41:491-501.


  103. Kelsen DP, Ginsberg R, et al. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31; 339(27):1979-1984.


  104. Kent DM, Hayward RA. Limitations of applying summary results of clinical trials to individual patients: The need for risk stratification. JAMA 2007; 298(10)1209-1212.


  105. Kestle J, Milner R, Drake J. An assessment of observer bias in shunt design trial. Pediatric Neurosurg 1999; 30:57-61.


  106. Kestle J, Milner R, Drake J. The shunt design trial: variation in surgical experience did not influence shunt survival. Pediatr Neurosurg 1999; 30:283-287.


  107. Kieser M, Friede T. Planning and analysis of three-arm non-inferiority trials with binary endpoints. Statist Med, 2007;26:253-273.


  108. Knatterud GL, Forman SA, Canner PL. Design of data forms. Cont Clin Trials 1983; 4:429-440.


  109. Krag DN, Ashikaga T, Harlow SP, Skelly JM, et al. for the National Surgical Adjuvant Breast and Bowel Project. Surgeon Training, Protocol Compliance, and Technical Outcomes From Breast Cancer Sentinel Lymph Node Randomized Trial. Journal of the National Cancer Institute 2009 101(19):1356-62.


  110. Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Cont Clin Trials 1981; 2:93-114.


  111. Law S, Wong J. Use of controlled randomized trials to evaluate new technologies and new operative procedures in surgery. J Gastrointest Surg 1998; 2:494-495.


  112. Lee YJ, et al. Two-stage plans for patient accrual in phase II cancer clinical trials. Cancer Treat Rep 1979; 63:1721-1726.


  113. Lipowski EE. Developing great research questions. Am J Health-Syst Pharm 2008;65:1667-70.


  114. Liu MB and Davis K. Lessons from a Horse Named Jim: A clinical trials manual from the Duke Clinical Research Institute. 2001.


  115. Lundberg GD, Glass RM. What does authorship mean in a peer-reviewed medical journal? JAMA 1996; 276:75


  116. Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med 1999; 341:992-996.


  117. Majeed AW, Troy G, Nicholl JP, et al. Randomized, prospective, single blind comparison of laparoscopic versus small-incision cholecystectomy. Lancet 1996; 347:989-994.


  118. Mant D. Can randomised trials inform clinical decisions about individual patients? Lancet 1999; 353:743-746.


  119. Marso SP, Bhatt DL, Roe MT, Houghtaling Plea. Enhanced efficacy of eptifibatide administration in patients with acute coronary syndrome requiring in-hospital coronary artery bypass grafting. Circulation 2000; 102:2952-2958.


  120. McFadden E. Management of Data in Clinical Trials, John Wiley & Sons, Inc., 1998; This is one of the first books entirely devoted to this topic and us is an excellent resource.


  121. McLeod RS: Primer on Clinical Trials. In: Surgical Arithmetic: Epidemiological Statistical and Outcome Based Approach to Surgical Practice. Ed: Rosenberg L, Joseph L, Barkun A. Pub: Landes Bioscience, Georgetown, Texas 2000.


  122. McLeod RS. Evidence Based Surgery [abstract]. Chapter Taken from: Norton, JA et al. Surgery, Basic Science and Clinical Evidence. Springer-Verlag 2000.


  123. McLeod RS. Issues in Surgical Trials. World J Surg 1999.


  124. McLeod RS, Wright JG, Solomon MJ, Hu X, Walters BC, Lossing A. Randomized controlled trials in surgery: issues and problems. Surgery 1996; 119:483-486.


  125. Melander H, Ahlqvist-Rastad J, Meijer G et al, Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003; 326.


  126. Moher D, Dulberg CS, Wells G. Statistical Power, Sample Size and Their Reporting in Randomized Controlled Trials. JAMA 1994; 272:122-124.


  127. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analysis? Lancet 1998; 352:609-613.


  128. Moher D, Schulz K, Altman D, for the CONSORT group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285:1987-1991.


  129. Monastersly R. The number that’s devouring science. Chron of Higher Ed. 2005 Oct 14.


  130. Moreno JD. IRBs under the microscope. Kennedy Inst Ethics J 1998; 8:329-337.


  131. Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during clinical research. JAMA 2001; 285:1201-1205.


  132. Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002; 347(2):81-88.


  133. The MOS Short Form (SF 36)


  134. Neaton DJ, Duchene AG, Svendsen KH, Wentworth D. An examination of the efficacy of some quality assurance methods commonly employed in clinical trials. Stat Med, 1990; 9:115-24.


  135. Neumayer L. Design and conduct issues in surgical clinical trials. Amer J of Surg 2004; 188 (Suppl to Dec 2004):17S-21S.


  136. Neumeyer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons, Jr. R, Dunlop D, Gibbs J, Reda D, Henderson W. Open Mesh versus Laparoscopic Mesh Repair of Inguinal Hernia. N Engl J Med 2004; 350(18):1819-27.


  137. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade stenosis. N Engl J Med 1991; 325:445-453.


  138. Olschewski M, Schumacher M, Davis KB. Analysis of randomized and nonrandomized patients in clinical trials using the comprehensive cohort follow-up study design. Controlled Clinical Trials 1992; 13:226-239.


  139. Oxman AD and Guyatt GH. A consumer’s guide to subgroup analyses. Annals of Internal Medicine 1992;116:78-84.


  140. Passamani E. Clinical Trials - are they ethical? N Eng J Med 1991; 324:1589-1592.


  141. Peduzzi P, Henderson W., Hartigan P and Lavori P. Analysis of Randomized Controlled Trials. Epidemiologic Reviews 2002;24:26-38.


  142. Peto R, Baigent C. Trials: the next 50 years. BMJ 1998; 317:1170-1171.


  143. Peto R, Collins R, Gray R. Large-scale randomized evidence: Large, simple trials and overviews of trials. J Clin Epidemiol 1995; 48:23-40.


  144. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976; 34:585-612.


  145. Pocock S. Clinical trials with multiple outcomes: a statistical perspective on their design analysis and interpretation. Controlled Clinical Trials 1997; 18:530-545.


  146. Pocock SL. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N England J Med 1987; 317:426-432.


  147. Primo NL, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment, Journal of Clinical Oncology 2001; 19:1728-1733.


  148. Reed JF, Slaichert W. Statistical proof in inconclusive negative trials. Archives Internal Medicine 1981; 141:1307-1310.


  149. Relman AS. Lessons from the Darsee affair.(editorial). N Engl J Med 1982; 308:1415-1417.


  150. Research Methodology, II: controlled clinical trials. In: Encyclopedia of Bioethics. 1996; 4:2278-2285.


  151. Richardson MA, Post-White J, Singletary SE, Justice B. Recruitment for complementary/alternative medicine trials: who participates after breast cancer? Ann Behav Med 1998; 20:190-198.


  152. Rothman KJ. Significance questing. (Editorial). Ann Int Med. 1986; 105:445-457.


  153. Rothwell PM. Treating Individuals 2. Subgroup analysis in randomized clinical trials: importance, indications, and interpretation. Lancet 2005; 77:176-186 and 270-260.


  154. Rule JT and Shamoo AE. Ethical Issues in Research Relationships Between Universities and Industry. Accountability in Research. 1997 OPA; 5:239-249.


  155. Sacks H, Chalmers TC, Smith H. Randomized versus historical controls for clinical trials. Am J Med 1982; 72:233-240.


  156. Schork AM, Remington RO. The determination of sample size in treatment-control comparisons for chronic disease studies in which dropout or non-adherence is a problem. J Chron Dis. 1967; 20:233-239.


  157. Schulman KA, Seils DM, Timbie JW, et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors, N Engl J Med 2002; 347(17).


  158. Schulz KF. Subverting randomization in controlled trials. JAMA 1995; 274:1456-1458.


  159. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273:408-412.


  160. Scultz KF, Grimes DA. Multiplicity in randomised trials I: endpoints and treatments. Lancet, 2005;365:1591-1595.


  161. Shakespeare TP, Gebski VJ, Veness MJ, Simes J. Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours. Lancet 2001; 357:1349-1353.


  162. Shapiro MF, Charrow RP. The role of data audits in detecting scientific misconduct. JAMA, 1989; 261:2505-11


  163. Shapiro MF, Charrow RP. Scientific misconduct in the investigational drug trials. N Engl J Med, 1985; 312:731-6.


  164. Shapiro WR, Green SB, Burger PC, et al. A randomized comparison of intra-arterial versus intravenous BCNU, with or without intravenous 5-fluorouracil, for newly diagnosed patients with malignant glioma. J Neurosurg 1992; 76:772-781.


  165. Sheldon TA. Systematic reviews and meta-analyses: the value for surgery. Br J Surg 1999; 86:977-978.


  166. Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med 1999; 337:1436-1440.


  167. Shuster E. The Nuremberg Code: Hippocratic ethics and human rights. Lancet 1998; 351:974-977.


  168. Shuster JJ. Practical Handbook of sample size guidelines for clinical trials. Boca Raton, CRC Press, 1993. (Comes with program for survival analysis sample sizes).


  169. Sibbald B, Roland M. Why are randomised controlled trials important? BMJ 1998; 316:201


  170. Silberner J. Remodeling IRBs. Hastings Center Report 1998; 5.


  171. Silverman H: Ethical issues during the conduct of clinical trials. Proc Am Thorac Soc. 2007 May;4(2):180-4.


  172. Simon R. Confidence Intervals for Reporting Results of Clinical Trials. Annals of Internal Medicine 1986; 105:429-435.


  173. Smith R. Authorship: time for a paradigm shift? (Editorial). BMJ 1997; 314:992.


  174. Smith-Tyler J: Informed consent, confidentiality, and subject rights in clinical trials. Proc Am Thorac Soc. 2007 May;4(2):189-93.


  175. Solomon MJ, Laxamana A, Devore L, McLeod RS. Randomized controlled trials in surgery. Surgery 1994; 115:707-712.


  176. Spilker B, Schoenfelder J, editors. Data collection forms in clinical trials. New York: Raven Press, 1991:


  177. Spitzer WO, Feinstein AR, Sackett DL. What is a health care trial? JAMA 1975; 233:161-163.


  178. Sprague S, Leece P, Bhandari M, S.P.R.I.N.T. Investigators, et al. Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Control Clin Trials 2003 Dec; 24(6): 719-725.


  179. Sweeney KG, MacAuley D, Gray DP. Personal significance: the third dimension. Lancet 1998; 351:134-136.


  180. Tamhane AC, Dunlop DD. Basic concepts of inference. In: Anonymous Statistics and Data Analysis: from elementary to intermediate. Upper Saddle River, N.J.: Prentice-Hall, 2000:


  181. Tramèr MR, Reynolds DJM, Moore RA, McQuay HJ. When placebo controlled trials are essential and equivalence trials are inadequate. BMJ 1999; 317:875-880.


  182. Tukey JW. Tightening the clinical trial. Controlled Clin Trials 1993; 14:266-285.


  183. Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med 1997; 330:309-315.


  184. Wagner E, Tooley PJH, Emanuel MB, et al. How to do it: get patients’ consent to enter clinical trials.BMJ 1995; 311:734-737.


  185. Walsh TN, Noonan N, et al. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15; 335(7):462-467.


  186. Wells J. Mammography and the politics of randomized controlled trials. BMJ 1998; 317:1224-1230.


  187. Whalen GF and Ferrans CE. Quality of life as an outcome in clinical trials and cancer care: a primer for surgeons. J Clin Oncol 2001; 77:270-260.


  188. Woolf SH, Battista RN, Anderson GM, et al. Assessing the Clinical Effectiveness of Preventive Maneuvers: analytic principals and systematic methods in reviewing evidence and developing clinical practice recommendations. J Clin Epidemiol. 1990; 43(9):897-905.


  189. Wright JG, McLeod RS, et al. Measurement in surgical clinical research. Surgery 1996; 119(3):241-244.


  190. Yadav JS, Wholey MH, Kuntz RE, et.al. Protected carotid-artery stenting versus endarterectomy in high risk patients. NEJM, 2004;351:1493-1501.


  191. Yamuah LK, The role of data management in health: a case study in developing countries, Drug Information Journal 2001; 35:707-712.


  192. Yeomans KA, Richards C, Vernon SW, Vogel VG. The effect of physician recommendation on enrollment in the breast cancer chemoprevention trial. Prev Med 1998; 27:713-719.

 

Revised February 17, 2011