Systematic review about data quality and protocol compliance in clinical trials;Systematisches Review über Datenqualität und Protokoll-Compliance in klinischen Studien

Deutsche Gesellschaft fur Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS)

Volumn 4, Issue 3, 2008, Pages

  Ohmann, Christian ^a   Brosteanu, Oana ^b   Pfistner, Beate ^c,d   Houben, Peggy ^b   Ihrig, Kristina ^e   Meyer, Sandra ^f,g   Paulus, Ursula ^c   Strenge Hesse, Anke ^c   Zettelmeyer, Ulrike ^c   Schwarz, Gabriele ^h  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b UNIVERSITY OF LEIPZIG   (Germany)

^c UNIVERSITY OF COLOGNE   (Germany)

^d UNIVERSITY OF BONN   (Germany)

^e GOETHE UNIVERSITY   (Germany)

^f HANNOVER MEDICAL SCHOOL   (Germany)

^g Center for HIV and Hepatogastroenterology   (Germany)

^h FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES   (Germany)

Author keywords

Clinical trial; Data quality; Protocol compliance; Systematic review

Indexed keywords

CLINICAL TRIAL; DATA QUALITY; INCLUSION AND EXCLUSIONS; NATIONAL CANCER INSTITUTE; QUALITY ASSURANCE PROCEDURES; QUALITY ASSURANCE SYSTEMS; QUALITY MANAGEMENT SYSTEMS; SYSTEMATIC REVIEW;

DATA REDUCTION; DRUG DOSAGE; EXPERIMENTS; MEDICAL APPLICATIONS; METADATA; MONITORING; QUALITY ASSURANCE; QUALITY MANAGEMENT; RADIOTHERAPY; SAFETY ENGINEERING; SEARCH ENGINES; TELEMEDICINE;

COMPLIANCE CONTROL;

EID: 77149128826     PISSN: 18608779     EISSN: 18609171     Source Type: Conference Proceeding    
DOI: None     Document Type: Conference Paper

References (50)

1. Roos DE, Davis SR, Turner SL, O'Brien PC, Spry NA, Burmeister BH, Hoskin PJ, Ball DL. Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05). Radiother Oncol. 2003;67(2):207-12.
2. Vantongelen K, Rotmensz N, van der Schueren E. Quality control of validity of data collected in clinical trials. EORTC Study Group on Data Management (SGDM). Eur J Cancer Clin Oncol. 1989;25(8):1241-7.
3. Favalli G, Vermorken JB, Vantongelen K, Renard J, Van Oosterom AT, Pecorelli S. Quality control in multicentric clinical trials. An experience of the EORTC Gynecological Cancer Cooperative Group. Eur J Cancer. 2000;36(9):1125-33.
4. Begg CB, Carbone PP, Elson PJ, Zelen M. Participation of community hospitals in clinical trials: analysis of five years of experience in the Eastern Cooperative Oncology Group. N Engl J Med. 1982;306(18):1076-80.
5. Weiss RB, Vogelzang NJ, Peterson BA, Panasci LC, Carpenter JT, Gavigan M, Sartell K, Frei E 3rd, McIntyre OR. A successful system of scientific data audits for clinical trials. A report from the Cancer and Leukemia Group B. JAMA. 1993;270(4):459-64.
6. Sylvester RJ, Pinedo HM, De Pauw M, Staquet MJ, Buyse ME, Renard J, Bonadonna G. Quality of institutional participation in multicenter clinical trials. N Engl J Med. 1981;305(15):852-5.
7. Verweij J, Nielsen OS, Therasse P, van Oosterom AT. The use of a systemic therapy checklist improves the quality of data acquisition and recording in multicentre trials. A study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 1997;33(7):1045-9.
8. Weiss GR, Kuebler SK, Clark GM, Kisner DL, Coltman CA; the Southwest Oncology Group Operations Office. Response assessment errors for all southwest oncology group (SWOG) clinical trials are more likely overestimates of response. Proceedings of ASCO. 1987;6:227.
9. Sunderland M, Kuebler S, Weiss G, Coltman C; SWOG Operations Office. Compliance with protocol: quality assurance (QA) data from the southwest oncology group (SWOG). Proceedings of ASCO. 1987;6:229.
10. Mauer JK, Hoth DF, Macfarlane DK, Hammershaimb LD, Wittes RE. Site visit monitoring program of the clinical cooperative groups: results of the first 3 years. Cancer Treat Rep. 1985;69(10):1177-87.
11. Steward WP, Vantongelen K, Verweij J, Thomas D, Van Oosterom AT. Chemotherapy administration and data collection in an EORTC collaborative group-can we trust the results? Eur J Cancer. 1993;29A(7):943-7.
12. Christian MC, McCabe MS, Korn EL, Abrams JS, Kaplan RS, Friedman MA. The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06. N Engl J Med. 1995;333(22):1469-74.
13. Rouff J, Child C. Application of quality improvement theory and process in a national multicenter HIV/AIDS clinical trials network. Qual Manag Health Care. 2003;12(2):89-96.
14. O'Sullivan DP, Needham CA, Bangs A, Atkin K, Kendall FD. Postmarketing surveillance of oral terbinafine in the UK: report of a large cohort study. Br J Clin Pharmacol. 1996;42(5):559-65.
15. Kouloulias VE, Bosset JF, van Tienhoven G, Davis BJ, Pierart M, Poortmans P; EORTC Radiotherapy Group. European Organization for Research and Treatment of Cancer. Quality assurance in the EORTC 22921 trial on preoperative radiotherapy with or without chemotherapy for resectable rectal cancer: evaluation of the individual case review procedure. Eur J Cancer. 2002;38(14):1849-56.
16. Seegenschmiedt MH, Sauerbrei W, Sauer R, Schumacher M, Schauer A, Rauschecker HF, Dinkloh H, Dühmke E, Haase KD, Haase W, Heisen E, Heinze HG, Janik I, Szepesi S. Quality control review for radiotherapy of small breast cancer: analysis of 708 patients in the GBSG I trial. German Breast Study Group (GBSG). Strahlenther Onkol. 1993;169(6):339-50.
17. Schaake-Koning C, Kirkpatrick A, Kröger R, van Zandwijk N, Bartelink H. The need for immediate monitoring of treatment parameters and uniform assessment of patient data in clinical trials. A quality control study of the EORTC Radiotherapy and Lung Cancer Cooperative Groups. Eur J Cancer. 1991;27(5):615-9.
18. Wallner PE, Lustig RA, Pajak TF, Robinson G, Davis LW, Perez CA, Seydel HG, Marcial VA, Laramore GE. Impact of initial quality control review on study outcome in lung and head/neck cancer studies-review of the Radiation Therapy Oncology Group experience. Int J Radiat Oncol Biol Phys. 1989;17(4):893-900.
19. Steigler A, Mameghan H, Lamb D, Joseph D, Matthews J, Franklin I, Turner S, Spry N, Poulsen M, North J, Kovacev O, Denham J. A quality assurance audit: phase III trial of maximal androgen deprivation in prostate cancer (TROG 96.01). Australas Radiol. 2000;44(1):65-71.
20. Roos DE, Davis SR, O'Brien PC, Hoskin PJ, Spry NA, Burmeister BH, Turner SL, Bernshaw DM. Eligibility audits for the randomized neuropathic bone pain trial (TROG 96.05). Australas Radiol. 2000;44(3):303-7.
21. Hamilton C, Poulsen M, Walker Q, Krawitz H, Hindley A, Spry N, Peters L, Lamb D, Denham J, Steigler A. Quality assurance audit in an Australasian phase III trial of accelerated radiotherapy for head and neck cancer (TROG 91.01). Trans-Tasman Radiation Oncology Group. Australas Radiol. 1999;43(2):227-32.
22. ICH Topic E6, Guide for Good Clinical Practice. Consolidated Guideline vom 1.5.1996, EMEA CPMP/ICH/135/95, in Kraft getreten am 17.1.97.
23. Cook S, ed. Surviving quality assurance audits in: Clinical Studies Management: A Practical Guide to Success. Boca Raton: CRC Press LLC; 2004.
24. Witte PD, Schenk J, Schwarz J, Kori-Linder C, Hrsg. Ordnungsgemä ße klinische Prüfung. Good Clinical Practice. Berlin: Habrich; 2000.
25. Poy E. Objectives of QC systems and QA function in clinical research. Qual Assur. 1993;2(4):326-31.
26. Knatterud GL, Rockhold FW, George SL, Barton FB, Davis CE, Fairweather WR, Honohan T, Mowery R, O'Neill R. Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials. 1998;19(5):477-93.
27. Svolba G, Bauer P. Statistical quality control in clinical trials. Control Clin Trials. 1999;20(6):519-30.
28. Gassman JJ, Owen WW, Kuntz TE, Martin JP, Amoroso WP. Data quality assurance, monitoring, and reporting. Control Clin Trials. 1995;16(2 Suppl):104S-136S.
29. Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz). In der Fassung vom 26.7.1999, neugefasst durch Bekanntmachung vom 11.12.1998 (BGBI. IS.3586), inklusive zwölftes Gesetz zur Änderung des Arzneimittelgesetzes vom 30. Juli 2004 (BGBI. IS.2031), in Kraft getreten am 06. August 2004, zuletzt geändert durch Artikel 1 des Gesetzes zur Änderung arzneimittelrechtlicher Vorschriften vom 15. April 2005 (BGBI. IS. 1068), in Kraft getreten am 27. April 2005.
30. Verordnung über die Anwendung der Guten Klinischen Praxis bei der Durchführung von klinischen Prüfung mit Arzneimitteln zur Anwendung am Menschen (GCP- Verordnung - GCP-V). In der Fassung vom 20.12.2001 (BGBI. IS. 3854), geändert durch Artikel 1§10 der Verordnung vom 9.8.2004 (Bundesgesetzblatt Jahrgang 2004, Teil 1, Nr. 42, 12.8.2004).
31. Therasse P, De Mulder PH. Quality assurance in medical oncology within the EORTC. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002;38 Suppl 4:S152-4.
32. Landheer ML, Therasse P, van de Velde CJ. Quality assurance in surgical oncology (QASO) within the European Organization for Research and Treatment of Cancer (EORTC): current status and future prospects. Eur J Cancer. 2001;37(12):1450-62.
33. Weiss RB. Systems of protocol review, quality assurance, and data audit. Cancer Chemother Pharmacol. 1998;42 Suppl:S88-92.
34. Lasser NL, Lamb S, Dischinger P, Kirkpatrick K. Background and organization of quality control in the Multiple Risk Factor Intervention Trial. Control Clin Trials. 1986;7(3 Suppl):1S-16S.
35. Nonnenmacher M, Weiland D, Stausberg J. Datenqualität in der Medizinischen Forschung. Leitlinie zum adaptiven Management von Datenqualität in Kohortenstudien und Registern. Berlin: Medizinische Wissenschaftliche Verlagsgesellschaft; 2007.
36. Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-96.
37. Zettelmeyer U, Pfistner B, Diehl V, Paulus U. On-site-Monitoring als Instrument zur Qualitätssicherung von Daten bei Therapieoptimierungsstudien [Abstract]. In: 50. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds), 12. Jahrestagung der Deutschen Arbeitsgemeinschaft für Epidemiologie. Freiburg im Breisgau, 12.-15.09.2005. Düsseldorf, Köln: German Medical Science; 2005. Doc 05gmds408. Available from: http://www.egms.de/en/meetings/gmds2005/05gmds317. shtml
38. Office of science and technology policy. Proposed federal policy on research misconduct to protect the intergrity of the research record. Federal Register. 1999;64:55722-5.
39. Ethics and fraud. Nature. 2006;439(7073):117-8.
40. Weiss RB, Rifkin RM, Stewart FM, Theriault RL, Williams LA, Herman AA, Beveridge RA. High-dose chemotherapy for high-risk primary breast cancer: an on-site review of the Bezwoda study. Lancet. 2000;355(9208):999-1003.
41. Weiss RB, Gill GG, Hudis CA. An on-site audit of the South African trial of high-dose chemotherapy for metastatic breast cancer and associated publications. J Clin Oncol. 2001;19(11):2771-7.
42. Schmidt J, Gertzen H, Aschenbrenner KM, Ryholt-Jensen S. Four corporate QA specialists show how they used a combination of on-site audit and biometrical methods to detect cases of fraud by three investigators. Appl Clin Trials. 1995;4:40-9.
43. O'Donnell P. Facing up to Fraud. Appl Clin Trials. 1993;2:36-40.
44. NCI issues information on falsified data in NSABP trials. Natl Cancer Inst. 1994;86(7):487-9.
45. Shapiro MF, Charrow RP. The role of data audits in detecting scientific misconduct. Results of the FDA program. JAMA. 1989;261(17):2505-11.
46. Bramstedt KA. A study of warning letters issued to clinical investigators by the United States Food and Drug Administration. Clin Invest Med. 2004;27(3):129-34.
47. Eichenwald K, Kolata G. A doctor's drug studies turn into fraud. NY Times (Print). 1999 May 17:A1, A16.
48. Buyse M, George SL, Evans S, Geller NL, Ranstam J, Scherrer B, Lesaffre E, Murray G, Edler L, Hutton J, Colton T, Lachenbruch P, Verma BL. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med. 1999;18(24):3435-51.
49. Sudbø J, Lee JJ, Lippman SM, Mork J, Sagen S, Flatner N, Ristimäki A, Sudbø A, Mao L, Zhou X, Kildal W, Evensen JF, Reith A, Dannenberg AJ. Non-steroidal anti-inflammatory drugs and the risk of oral cancer: a nested case-control study. Lancet. 2005;366(9494):1359-66.
50. Retraction in: Horton R. Lancet. 2006;367(9508):382.