Publication and reporting conduct for pharmacodynamic analyses of tumor tissue in early-phase oncology trials

Clinical Cancer Research

Volumn 18, Issue 23, 2012, Pages 6478-6484

  Freeman, Georgina A ^a   Kimmelman, Jonathan ^a  

^a MCGILL UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; CYTOTOXIC AGENT;

ABSTRACT REPORT; ARTICLE; CANCER RESEARCH; CLINICAL TRIAL (TOPIC); DRUG INFORMATION; HEALTH CARE ORGANIZATION; HUMAN; INFORMATION PROCESSING; INVASIVE PROCEDURE; ONCOLOGY; PHARMACODYNAMICS; PRIORITY JOURNAL; PUBLICATION; PUBLISHING; QUESTIONNAIRE; TISSUE TRANSPLANTATION; TUMOR BIOPSY;

ANTINEOPLASTIC AGENTS; BIOPSY; CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS; PUBLICATIONS; QUESTIONNAIRES; RESEARCH REPORT;

EID: 84870333648     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-12-1384     Document Type: Article

References (48)

1. Twelves C. Practical aspects of pharmacokinetics and pharmacodynamics. In:Eisenhauer EA, Twelves C, Buyse M, editors. Phase 1 cancer clinical trials: a practical guide. New York: Oxford University Press; 2006. p. 209-43.
2. Olson EM, Lin NU, Krop IE, Winer EP. The ethical use of mandatory research biopsies. Nat Rev Clin Oncol 2011;8:620-5.
3. London AJ. Two dogmas of research ethics and the integrative approach to human-subjects research. J Med Philos 2007;32: 99-116. (Pubitemid 46598163)
4. London AJ, Kimmelman J, Emborg ME. Research ethics. Beyond access vs. protection in trials of innovative therapies. Science 2010;328:829-30.
5. Brody H, Miller FG. The clinician-investigator: unavoidable but manageable tension. Kennedy Inst Ethics J 2003;13:329-46. (Pubitemid 38178106)
6. Brown A, Wendler D, Camphausen K, Miller F, Citrin D. Performing nondiagnostic research biopsies in irradiated tissue: a review of scientific, clinical, and ethical considerations. J Clin Oncol 2008;26: 3987-94.
7. Szynglarewicz B, Matkowski R, Kasprzak P, Forgacz J, Zolnierek A, Halon A, et al. Pain experienced by patients during minimal-invasive ultrasound-guided breast biopsy: vacuum-assisted vs core-needle procedure. Eur J Surg Oncol 2011;37:398-403.
8. Hemmer JM, Kelder JC, van Heesewijk HP. Stereotactic large-core needle breast biopsy: analysis of pain and discomfort related to the biopsy procedure. Eur Radiol 2008;18:351-4. (Pubitemid 351234056)
9. Riley TR 3rd. Predictors of pain medication use after percutaneous liver biopsy. Dig Dis Sci 2002;47:2151-3.
10. Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg 2003;96:1392-6. (Pubitemid 36512882)
11. Watmough S, Flynn M. A review of pain management interventions in bone marrow biopsy. J Clin Nurs 2011;20:615-23.
12. Simon JR, Kalbhen CL, Cooper RA, Flisak ME. Accuracy and complication rates of US-guided vacuum-assisted core breast biopsy: initial results. Radiology 2000;215:694-7. (Pubitemid 30346002)
13. Wilke LG, McCall LM, Posther KE, Whitworth PW, Reintgen DS, Leitch AM, et al. Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol 2006;13:491-500.
14. Tomiyama N, Yasuhara Y, Nakajima Y, Adachi S, Arai Y, Kusumoto M, et al. CT-guided needle biopsy of lung lesions: a survey of severe complication based on 9783 biopsies in Japan. Eur J Radiol 2006; 59:60-4.
15. Felip E, Rojo F, Reck M, Heller A, Klughammer B, Sala G, et al. A phase II pharmacodynamic study of erlotinib in patients with advanced nonsmall cell lung cancer previously treated with platinum-based chemotherapy. Clin Cancer Res 2008;14:3867-74.
16. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. December 2010.
17. World Medical Association. Declaration of Helsinki. World Med J 2008;54:122-5.
18. Basic HHS Policy for Protection of Human Research Subjects, 45 C.F.R. Sect. 46.111 (2009).
19. Ratain MJ, Glassman RH. Biomarkers in phase I oncology trials: signal, noise, or expensive distraction? Clin Cancer Res 2007;13: 6545-8. (Pubitemid 350206786)
20. Davis DW, Takamori R, Raut CP, Xiong HQ, Herbst RS, Stadler WM, et al. Pharmacodynamic analysis of target inhibition and endothelial cell death in tumors treated with the vascular endothelial growth factor receptor antagonists SU5416 or SU6668. Clin Cancer Res 2005;11: 678-89. (Pubitemid 40116895)
21. Agulnik M, Oza AM, Pond GR, Siu LL. Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents. J Clin Oncol 2006;24:4801-7. (Pubitemid 46655611)
22. Dowlati A, Haaga J, Remick SC, Spiro TP, Gerson SL, Liu L, et al. Sequential tumor biopsies in early phase clinical trials of anticancer agents for pharmacodynamic evaluation. Clin Cancer Res 2001;7: 2971-6. (Pubitemid 32963813)
23. Agulnik M, da Cunha Santos G, Hedley D, Nicklee T, Dos Reis PP, Ho J, et al. Predictive and pharmacodynamic biomarker studies in tumor and skin tissue samples of patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with erlotinib. J Clin Oncol 2007;25:2184-90. (Pubitemid 46954641)
24. Camacho LH, Bacik J, Cheung A, Spriggs DR. Presentation and subsequent publication rates of phase I oncology clinical trials. Cancer 2005;104:1497-504. (Pubitemid 41356165)
25. Hoeg RT, Lee JA, Mathiason MA, Rokkones K, Serck SL, Crampton KL, et al. Publication outcomes of phase II oncology clinical trials. Am J Clin Oncol 2009;32:253-7.
26. American Society of Clinical Oncology (ASCO). Abstracts - ASCO 2011 [cited 2011 Sept 1]. Available from: http://www.asco.org/ASCOv2/Meetings/ Abstracts.
27. Peppercorn J, Shapira I, Collyar D, Deshields T, Lin N, Krop I, et al. Ethics of mandatory research biopsy for correlative end points within clinical trials in oncology. J Clin Oncol 2010;28:2635-40.
28. Kimmelman J. Lost in translation: the ethics and policy of human gene transfer. New York: Cambridge University Press; 2009.
29. Kummar S, Kinders R, Gutierrez ME, Rubinstein L, Parchment RE, Phillips LR, et al. Phase 0 clinical trial of the poly (ADP-ribose) polymerase inhibitor ABT-888 in patients with advanced malignancies. J Clin Oncol 2009;27:2705-11.
30. Helft PR, Daugherty CK. Are we taking without giving in return? The ethics of research-related biopsies and the benefits of clinical trial participation. J Clin Oncol 2006;24:4793-5. (Pubitemid 46630904)
31. Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P. Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med 2002;251:156-68. (Pubitemid 34146699)
32. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.
33. Dickersin K, Rennie D. Registering clinical trials. JAMA 2003;290: 516-23. (Pubitemid 37448502)
34. Callaham ML, Wears RL, Weber EJ, Barton C, Young G. Positiveoutcome bias and other limitations in the outcome of research abstracts submitted to a scientific meeting. JAMA 1998;280:254-7. (Pubitemid 28493899)
35. Topol EJ. Failing the public health - rofecoxib, Merck, and the FDA. N Engl J Med 2004;351:1707-9. (Pubitemid 39383201)
36. McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM. Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 2005;97:1180-4. (Pubitemid 41258223)
37. McGuire WL. Breast cancer prognostic factors: evaluation guidelines. J Natl Cancer Inst 1991;83:154-5.
38. Fielding LP, Fenoglio-Preiser CM, Freedman LS. The future of prognostic factors in outcome prediction for patients with cancer. Cancer 1992;70:2367-77.
39. Concato J, Feinstein AR, Holford TR. The risk of determining risk with multivariable models. Ann Intern Med 1993;118:201-10. (Pubitemid 23034807)
40. Gasparini G, Pozza F, Harris AL. Evaluating the potential usefulness of new prognostic and predictive indicators in node-negative breast cancer patients. J Natl Cancer Inst 1993;85:1206-19. (Pubitemid 23223526)
41. Simon R, Altman DG. Statistical aspects of prognostic factor studies in oncology. Br J Cancer 1994;69:979-85. (Pubitemid 24161844)
42. Hall PA, Going JJ. Predicting the future: a critical appraisal of cancer prognosis studies. Histopathology 1999;35:489-94. (Pubitemid 30005374)
43. Thor AD, Liu S, Moore DH II, Edgerton SM. Comparison of mitotic index, in vitro bromodeoxyuridine labeling, and MIB-1 assays to quantitate proliferation in breast cancer. J Clin Oncol 1999;17: 470-7. (Pubitemid 29075230)
44. Gancberg D, Lespagnard L, Rouas G, Paesmans M, Piccart M, Di Leo A, et al. Sensitivity of HER-2/neu antibodies in archival tissue samples of invasive breast carcinomas. Correlation with oncogene amplification in 160 cases. Am J Clin Pathol 2000;113:675-82. (Pubitemid 33044308)
45. McShane LM, Aamodt R, Cordon-Cardo C, Cote R, Faraggi D, Fradet Y, et al. Reproducibility of p53 immunohistochemistry in bladder tumors. National cancer institute, bladder tumor marker network. Clin Cancer Res 2000;6:1854-64. (Pubitemid 30305082)
46. Paik S, Bryant J, Tan-Chiu E, Romond E, Hiller W, Park K, et al. Realworld performance of HER2 testing-national surgical adjuvant breast and bowel project experience. J Natl Cancer Inst 2002;94:852-4. (Pubitemid 34705057)
47. Roche PC, Suman VJ, Jenkins RB, Davidson NE, Martino S, Kaufman PA, et al. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst 2002;94:855-7. (Pubitemid 34705058)
48. Colburn WA, Lee JW. Biomarkers, validation and pharmacokinetic- pharmacodynamic modelling. Clinical Pharmacokinet 2003;42:997-1022. (Pubitemid 37186674)