Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle

Clinical Trials

Volumn 11, Issue 6, 2014, Pages 629-634

  Browne, Lois H ^a   Graham, Peter H ^a  

^a ST GEORGE HOSPITAL   (Australia)

Author keywords

Clinical trials; Follow up; GCP; Good clinical practice; Guidelines; Intention to treat; ITT; Loss to follow up; Missing outcome; Regulation

Indexed keywords

ARTICLE; AUSTRALIA AND NEW ZEALAND; CONTROLLED STUDY; FOLLOW UP; GOOD CLINICAL PRACTICE; HEALTH CARE PERSONNEL; HUMAN; INFORMATION PROCESSING; INTENTION TO TREAT ANALYSIS; STAFF TRAINING; AUSTRALIA; BREAST NEOPLASMS; EDUCATION; ETHICS; FEMALE; METHODOLOGY; NEW ZEALAND; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PERSONNEL; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS; STATISTICAL BIAS;

AUSTRALIA; BIAS (EPIDEMIOLOGY); BREAST NEOPLASMS; FEMALE; HUMANS; INTENTION TO TREAT ANALYSIS; NEW ZEALAND; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT COMPLIANCE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RESEARCH PERSONNEL;

EID: 84911434659     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774514542620     Document Type: Article

References (31)

1. Kramer JMA and Schulman KA. Transforming the economics of clinical trials. Discussion paper, Institute of Medicine of the National Academies, Duke University Medical Centre, April 2012, http://www.iom.edu/;/media/Files/Perspectives-Files/2012/Discussion-Papers/HSP-Drugs-Transforming-the-Economics.pdf (accessed 1 July 2014).
2. European Forum for Good Clinical Practice (EFGCP). Impact on clinical research of European legislation. Grant Agreement Number. HEALTH-F1-2007-201002, June 2009. Belgium: EFGCP.
3. Heritier SR, Gebski VJ and Keech AC. Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Med J Aust 2003; 179: 438-440.
4. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c869.
5. Altman DG. Missing outcomes in randomized trials: addressing the dilemma. Open Med 2009; 3(2): 51-53.
6. Cakir B, Gebski VJ and Keech AC. Flow of participants in randomised studies. Med J Aust 2003; 178: 347-349.
7. Campbell MJ. Doing clinical trials large enough to achieve adequate reductions in uncertainties about treatment effects. JLL Bulletin: commentaries on the history of treatment evaluation, 2012, www.jameslindlibrary.org (accessed 1 July 2014).
8. Freiman JA, Chalmers TC, Smith H, et al. The importance of beta, the Type II error and sample size in the design and interpretation of the randomised control trial. N Engl J Med 1978; 299(13): 690-694.
9. Madigan D, Sigelman DW, Mayer JW, et al. Under-reporting of cardiovascular events in the rofecoxib Alzheimer disease studies. Am Heart J 2012; 164(2): 186-193.
10. Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012; 367(14): 1355-1360.
11. Mallinckrodt C, Roger J, Chuang-Stein C, et al. Missing data: turning guidance into action. Stat Biopharm Res 2013; 5(4): 369-382.
12. Seaman SR and White IR. Review of inverse probability weighting for dealing with missing data. Stat Methods Med Res 2011; 22(3): 278-295.
13. European Medicines Agency. Guideline on missing data in confirmatory clinical trials. Doc. Ref CPMP/EWP/1776/99, April 2009. London: European Medicines Agency.
14. Vickers AJ and Altman DG. Statistics notes: missing outcomes in randomised trials. BMJ 2013; 346: f3438.
15. O'Neill RT and Temple R. The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it. Clin Pharmacol Ther 2012; 91(3): 550-554.
16. Akl EA, Briel M, You JJ, et al. Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review. BMJ 2012; 344: e2809.
17. ICH Harmonised Tripartite Guideline. Guideline for good clinical practice E6(R1). June 1996, http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E6-R1/Step4/E6-R1-Guideline.pdf (accessed 1 July 2014).
18. Millar EKA, Graham PH, O'Toole SA, et al. Prediction of local recurrence, distant metastases and death after breast-conserving therapy in early-stage invasive breast cancer using a five-biomarker panel. J Clin Oncol 2009; 27(28): 4701-4708.
19. Graham P, Millar E, Browne L, et al. Randomized trial shows reduced whole breast dose negates benefit of lumpectomy radiotherapy boost. In: Proceedings of the 29th ESTRO meeting, Barcelona, 12-16 September 2010 (Radioth Oncol 2010; 96(Suppl. 1): S145, oral presentation 383).
20. Therapeutic Goods Administration. The Australian clinical trial handbook. Australian Government, March 2006, http://www.tga.gov.au/pdf/clinical-trials-handbook.pdf (accessed 1 July 2014).
21. Van der Weijden F, Slot DE, Rosema M, et al. ITT in respect to GCP: a matter of diligence. J Clin Periodontol 2008; 35: 681-682.
22. Grimes DA, Hubacher D, Nanda K, et al. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet 2005; 366: 172-174.
23. Yusuf S. Damage to important clinical trials by over-regulation. Clin Trials 2010; 7: 622-625.
24. McMahon AD, Conway DI, MacDonald TM, et al. The unintended consequences of clinical trials regulations. PLoS Med 2009; 6(11): e1000131.
25. Sensible Guidelines Symposium.http://www.cannectin.ca/default.cfm?id=136 (2012, accessed 6 September 2013).
26. ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials E9. February 1998, http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E9/Step4/E9-Guideline.pdf (accessed 1 July 2014).
27. Little RJ, Cohen ML, Dickersin K, et al. The design and conduct of clinical trials to limit missing data. Stat Med 2012; 31: 3433-3443.
28. National Research Council of the National Academies. The prevention and treatment of missing data in clinical trials. Washington, DC: National Academies Press, 2010, pp. 39-45.
29. Wartenberg D and Thompson WD. Privacy versus public health: the impact of current confidentiality rules. Am J Public Health 2010; 100(3): 407-412.
30. Australian Government and National Health and Medical Research Council (NHMRC). National statement on ethical conduct in human research (Updated May 2013). Canberra, ACT, Australia: NHMRC, 2007.
31. Australian Government and National Health and Medical Research Council (NHMRC). Australian code for the responsible conduct of research. Canberra, ACT, Australia: NHMRC, 2007.