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Some Problems With Clinical Trials: James Ewing Lecture

Some Problems With Clinical Trials: James Ewing Lecture Abstract Dr Ewing was intimately associated with the Memorial Hospital for Cancer and Allied Diseases, New York, NY, from 1913 until his retirement in 1939, and his outstanding leadership in oncology had a major impact on both his contemporaries and those of us who followed. This society, devoted to oncology, was founded in 1940 as the James Ewing Society both to "further our knowledge of cancer" and to honor this great man. Some of you will remember our historic meeting in New Orleans in 1975, when we changed the name from the James Ewing Society to the Society of Surgical Oncology. Our president at that meeting, Dr Edward Scanlon, had the foresight and courage to realize that the membership of the James Ewing Society was an outstanding base for launching a new and much-needed national organization of surgical oncologists. There was considerable controversy over the name change, however; the major argument References 1. Robbins G. James Ewing: the man (the James Ewing Lecture) . Clin Bull Mem Sloan Kettering Cancer Center . 1978;8. No. (1) . 2. Ewing J. Lectures on Tumor Pathology . New York, NY: Robert C Gold & Associates; 1933. 3. Del Regato JA. James Ewing . Int J Radiat Oncol Biol Phys . 1977;2: 185-198.Crossref 4. Ewing J. Neoplastic Diseases . Philadelphia, Pa: WB Saunders Co; 1918. 5. Higgins GA. The Society of Surgical Oncology Lucy Wortham James Research Award: 1980: problems in clinical trials: lessons from the tuck uppers.' Cancer . 1981;47:2167-2171.Crossref 6. Bricker EM. Presidential address: tumoribus praeter naturam . Ann Surg . 1985;202:265-277.Crossref 7. Roddis LH. James Lind, the Founder of Nautical Medicine . New York, NY: Henry Schuman Inc; 1950. 8. Halsted WS. The treatment of wounds, IV: operations for carcinoma of the breast . Johns Hopkins Hosp Rep . 1891;2:277-280. 9. Fisher RA. Statistical Methods for Research Workers . Edinburgh, Scotland: Oliver & Boyd; 1925. 10. Crile G Jr. Results of simplified treatment of breast cancer . Surg Gynecol Obstet . 1964;118:517. 11. Longmire WP Jr, Kuzma JW, Dixon WJ. The use of triethylenethiophosphoramide as an adjuvant to the surgical treatment of gastric carcinoma . Ann Surg . 1968;167:293-312.Crossref 12. Noer RJ, Moore GE, Pickren JW, Stiver RB Jr. Breast adjuvant chemotherapy . Ann Surg . 1961;154:629-647.Crossref 13. Holden WD, Dixon WJ, Kuzma JW. The case of triethylenethiophosphoramide as an adjuvant to the surgical treatment of colorectal carcinoma . Ann Surg . 1967;165:481-503.Crossref 14. Higgins GA, Humphrey E, Juler GL, LeVeen HH, McCaughn J, Keehn RJ. Adjuvant chemotherapy in the surgical treatment of large bowel cancer . Cancer . 1976;38:1461-1466.Crossref 15. Higgins GA Jr. Special problems in the evaluation of results in adjuvant trial of cancer treatment . J Surg Oncol . 1978;10:321-326.Crossref 16. Baar J, Tannoch I. Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials . J Clin Oncol . 1989;7:969-978. 17. McKenna RJ Sr, Lazlo J, Durant J, et al. Ethical considerations . Cancer . 1990;65( (suppl) ):2407-2408.Crossref 18. Bailar JC III, Smith EM. Progress against cancer? N Engl J Med . 1986;314:1226-1232.Crossref 19. Ries LA, Hankey BF, Edwards BK, eds. Cancer Statistics Review (1973-1987) . Bethesda, Md: National Institutes of Health; 1990. Publication 90-2789. 20. Holland JF. Breaking the cure barrier: 13th annual David A. Karnofsky lecture . J Clin Oncol . 1983;1:75-90. 21. Detsky AS. Are clinical trials a cost-effective investment? JAMA . 1989;262:1795-1800.Crossref 22. Balch CM, Durant JR, Bartolucci AA. The impact of surgical quality control in multi-institutional group trials involving adjuvant cancer treatments . Ann Surg . 1983;198:164-167.Crossref 23. Jordan PH Jr, Thornby J. Should it be parietal cell vagotomy or selective vagotomy-antrectomy for treatment of duodenal ulcer?: a progress report . Ann Surg . 1987;205:572-590.Crossref 24. Hugh TB, Nankivell C, Meagher AP, Li B. Is closure of the peritoneal layer necessary in the repair of midline surgical abdominal wounds? World J Surg . 1990;14:231-234.Crossref 25. Millikan WJ, Warren WD, Henderson JM, et al. The Emory prospective randomized trial: selective versus nonselective shunt to control variceal bleeding . Ann Surg . 1985;201:712-722.Crossref 26. Sugerman HJ, Starkey JV, Birkenhauer R. A randomized prospective trial of gastric bypass versus vertical banded gastroplasty for morbid obesity and their effects on sweets versus non-sweets eaters . Ann Surg . 1987;205: 613-624.Crossref 27. Lawrence W Jr, Gehan EA, Hays DM. Prognostic significance of staging factors of the UICC staging system in childhood rhabdomyosarcoma: a report from the Intergroup Rhabdomyosarcoma Study (IRS III) . J Clin Oncol . 1987;5:46-54. 28. Gerard A, Berrod JL, Peine F, et al. Interim analysis of a phase III study on preoperative radiation therapy in resectable rectal carcinoma . Cancer . 1985;55:2373-2379.Crossref 29. Skeel RT. Quality of life assessment in cancer clinical trials: it's time to catch up . J Natl Cancer Inst . 1989;81:472-473.Crossref 30. The Gastrointestinal Tumor Study Group. Controlled trial of adjuvant chemotherapy following curative resection for gastric cancer . Cancer . 1982;49:1116-1122.Crossref 31. Higgins GA, Amadeo JH, Smith DE, et al. Efficacy of prolonged intermittent therapy with combined 5-FU and methyl CCNU following resection for gastric carcinoma . Cancer . 1983;52:1105-1112.Crossref 32. Wolmark N, Fisher B, Rockette H, et al. Postoperative adjuvant chemotherapy or BCG for colon cancer: results from NSABP protocol C-01 . J Natl Cancer Inst . 1988;80:30-36.Crossref 33. Spratt JS. Validity of the clinical alert on breast cancer . Am J Surg . 1990;159:195-197.Crossref 34. Lenhard RE Jr, Enterline JP, Crowley J, Ho GYF. The effects of distance from primary treatment centers on survival among patients with multiple myeloma . J Clin Oncol . 1987;5:1640-1645. 35. Longmire WP Jr. Whither the solid tumors: James Ewing lecture . Arch Surg . 1990;125:158-162.Crossref 36. Durant JR. Overview, current status of clinical trials . Cancer . 1990;65( (suppl) ):2371-2375.Crossref 37. MacKillop WJ, Ward GK, O'Sullivan B. The use of expert surrogates to evaluate clinical trials in non–small cell lung cancer . Br J Cancer . 1986;54: 661-667.Crossref 38. Moore MJ, O'Sullivan B, Tannock IF. How expert physicians would wish to be treated if they had genitourinary cancer . J Clin Oncol . 1988;6:1736-1745. 39. Coltman CA Jr. Southwest Oncology Group . Cancer . 1990; 65( (suppl) ):2385-2387.Crossref 40. Fleming ID. Clinical trials of cancer patients: the community practicing physician's perspective . Cancer . 1990;65( (suppl) ):2388-2390.Crossref 41. Nealon E. What Are Clinical Trials All About? Bethesda, Md: National Cancer Institute; 1988. 42. Raub WF. Remedies and Costs of Difficulties Hampering Clinical Research . Washington, DC: US Dept of Health and Human Services; 1989. 43. Haagensen CD. The choice of treatment for operable carcinoma of the breast . Surgery . 1974;76:685-714. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Surgery American Medical Association

Some Problems With Clinical Trials: James Ewing Lecture

Archives of Surgery , Volume 126 (3) – Mar 1, 1991

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Publisher
American Medical Association
Copyright
Copyright © 1991 American Medical Association. All Rights Reserved.
ISSN
0004-0010
eISSN
1538-3644
DOI
10.1001/archsurg.1991.01410270118019
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Abstract

Abstract Dr Ewing was intimately associated with the Memorial Hospital for Cancer and Allied Diseases, New York, NY, from 1913 until his retirement in 1939, and his outstanding leadership in oncology had a major impact on both his contemporaries and those of us who followed. This society, devoted to oncology, was founded in 1940 as the James Ewing Society both to "further our knowledge of cancer" and to honor this great man. Some of you will remember our historic meeting in New Orleans in 1975, when we changed the name from the James Ewing Society to the Society of Surgical Oncology. Our president at that meeting, Dr Edward Scanlon, had the foresight and courage to realize that the membership of the James Ewing Society was an outstanding base for launching a new and much-needed national organization of surgical oncologists. There was considerable controversy over the name change, however; the major argument References 1. Robbins G. James Ewing: the man (the James Ewing Lecture) . Clin Bull Mem Sloan Kettering Cancer Center . 1978;8. No. (1) . 2. Ewing J. Lectures on Tumor Pathology . New York, NY: Robert C Gold & Associates; 1933. 3. Del Regato JA. James Ewing . Int J Radiat Oncol Biol Phys . 1977;2: 185-198.Crossref 4. Ewing J. Neoplastic Diseases . Philadelphia, Pa: WB Saunders Co; 1918. 5. Higgins GA. The Society of Surgical Oncology Lucy Wortham James Research Award: 1980: problems in clinical trials: lessons from the tuck uppers.' Cancer . 1981;47:2167-2171.Crossref 6. Bricker EM. Presidential address: tumoribus praeter naturam . Ann Surg . 1985;202:265-277.Crossref 7. Roddis LH. James Lind, the Founder of Nautical Medicine . New York, NY: Henry Schuman Inc; 1950. 8. Halsted WS. The treatment of wounds, IV: operations for carcinoma of the breast . Johns Hopkins Hosp Rep . 1891;2:277-280. 9. Fisher RA. Statistical Methods for Research Workers . Edinburgh, Scotland: Oliver & Boyd; 1925. 10. Crile G Jr. Results of simplified treatment of breast cancer . Surg Gynecol Obstet . 1964;118:517. 11. Longmire WP Jr, Kuzma JW, Dixon WJ. The use of triethylenethiophosphoramide as an adjuvant to the surgical treatment of gastric carcinoma . Ann Surg . 1968;167:293-312.Crossref 12. Noer RJ, Moore GE, Pickren JW, Stiver RB Jr. Breast adjuvant chemotherapy . Ann Surg . 1961;154:629-647.Crossref 13. Holden WD, Dixon WJ, Kuzma JW. The case of triethylenethiophosphoramide as an adjuvant to the surgical treatment of colorectal carcinoma . Ann Surg . 1967;165:481-503.Crossref 14. Higgins GA, Humphrey E, Juler GL, LeVeen HH, McCaughn J, Keehn RJ. Adjuvant chemotherapy in the surgical treatment of large bowel cancer . Cancer . 1976;38:1461-1466.Crossref 15. Higgins GA Jr. Special problems in the evaluation of results in adjuvant trial of cancer treatment . J Surg Oncol . 1978;10:321-326.Crossref 16. Baar J, Tannoch I. Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials . J Clin Oncol . 1989;7:969-978. 17. McKenna RJ Sr, Lazlo J, Durant J, et al. Ethical considerations . Cancer . 1990;65( (suppl) ):2407-2408.Crossref 18. Bailar JC III, Smith EM. Progress against cancer? N Engl J Med . 1986;314:1226-1232.Crossref 19. Ries LA, Hankey BF, Edwards BK, eds. Cancer Statistics Review (1973-1987) . Bethesda, Md: National Institutes of Health; 1990. Publication 90-2789. 20. Holland JF. Breaking the cure barrier: 13th annual David A. Karnofsky lecture . J Clin Oncol . 1983;1:75-90. 21. Detsky AS. Are clinical trials a cost-effective investment? JAMA . 1989;262:1795-1800.Crossref 22. Balch CM, Durant JR, Bartolucci AA. The impact of surgical quality control in multi-institutional group trials involving adjuvant cancer treatments . Ann Surg . 1983;198:164-167.Crossref 23. Jordan PH Jr, Thornby J. Should it be parietal cell vagotomy or selective vagotomy-antrectomy for treatment of duodenal ulcer?: a progress report . Ann Surg . 1987;205:572-590.Crossref 24. Hugh TB, Nankivell C, Meagher AP, Li B. Is closure of the peritoneal layer necessary in the repair of midline surgical abdominal wounds? World J Surg . 1990;14:231-234.Crossref 25. Millikan WJ, Warren WD, Henderson JM, et al. The Emory prospective randomized trial: selective versus nonselective shunt to control variceal bleeding . Ann Surg . 1985;201:712-722.Crossref 26. Sugerman HJ, Starkey JV, Birkenhauer R. A randomized prospective trial of gastric bypass versus vertical banded gastroplasty for morbid obesity and their effects on sweets versus non-sweets eaters . Ann Surg . 1987;205: 613-624.Crossref 27. Lawrence W Jr, Gehan EA, Hays DM. Prognostic significance of staging factors of the UICC staging system in childhood rhabdomyosarcoma: a report from the Intergroup Rhabdomyosarcoma Study (IRS III) . J Clin Oncol . 1987;5:46-54. 28. Gerard A, Berrod JL, Peine F, et al. Interim analysis of a phase III study on preoperative radiation therapy in resectable rectal carcinoma . Cancer . 1985;55:2373-2379.Crossref 29. Skeel RT. Quality of life assessment in cancer clinical trials: it's time to catch up . J Natl Cancer Inst . 1989;81:472-473.Crossref 30. The Gastrointestinal Tumor Study Group. Controlled trial of adjuvant chemotherapy following curative resection for gastric cancer . Cancer . 1982;49:1116-1122.Crossref 31. Higgins GA, Amadeo JH, Smith DE, et al. Efficacy of prolonged intermittent therapy with combined 5-FU and methyl CCNU following resection for gastric carcinoma . Cancer . 1983;52:1105-1112.Crossref 32. Wolmark N, Fisher B, Rockette H, et al. Postoperative adjuvant chemotherapy or BCG for colon cancer: results from NSABP protocol C-01 . J Natl Cancer Inst . 1988;80:30-36.Crossref 33. Spratt JS. Validity of the clinical alert on breast cancer . Am J Surg . 1990;159:195-197.Crossref 34. Lenhard RE Jr, Enterline JP, Crowley J, Ho GYF. The effects of distance from primary treatment centers on survival among patients with multiple myeloma . J Clin Oncol . 1987;5:1640-1645. 35. Longmire WP Jr. Whither the solid tumors: James Ewing lecture . Arch Surg . 1990;125:158-162.Crossref 36. Durant JR. Overview, current status of clinical trials . Cancer . 1990;65( (suppl) ):2371-2375.Crossref 37. MacKillop WJ, Ward GK, O'Sullivan B. The use of expert surrogates to evaluate clinical trials in non–small cell lung cancer . Br J Cancer . 1986;54: 661-667.Crossref 38. Moore MJ, O'Sullivan B, Tannock IF. How expert physicians would wish to be treated if they had genitourinary cancer . J Clin Oncol . 1988;6:1736-1745. 39. Coltman CA Jr. Southwest Oncology Group . Cancer . 1990; 65( (suppl) ):2385-2387.Crossref 40. Fleming ID. Clinical trials of cancer patients: the community practicing physician's perspective . Cancer . 1990;65( (suppl) ):2388-2390.Crossref 41. Nealon E. What Are Clinical Trials All About? Bethesda, Md: National Cancer Institute; 1988. 42. Raub WF. Remedies and Costs of Difficulties Hampering Clinical Research . Washington, DC: US Dept of Health and Human Services; 1989. 43. Haagensen CD. The choice of treatment for operable carcinoma of the breast . Surgery . 1974;76:685-714.

Journal

Archives of SurgeryAmerican Medical Association

Published: Mar 1, 1991

References