Current Practices, Challenges, and Statistical Issues With Product Safety Labeling

Statistics in Biopharmaceutical Research

Volumn 5, Issue 3, 2013, Pages 180-193

  Crowe, Brenda ^a   Brueckner, Andreas ^b   Beasley, Charles ^a   Kulkarni, Pandurang ^a  

^a ELI LILLY AND COMPANY   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Adverse reaction; Causation; Core data sheet; Summary of product characteristics; United States package insert

Indexed keywords

ARTICLE; ATTRIBUTABLE RISK; DECISION MAKING; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEALTH CARE PERSONNEL; HUMAN; INCIDENCE; PATIENT GUIDANCE; PRACTICE GUIDELINE; SIDE EFFECT; STATISTICAL PARAMETERS; STRUCTURED QUESTIONNAIRE;

EID: 84884326669     PISSN: None     EISSN: 19466315     Source Type: Journal    
DOI: 10.1080/19466315.2013.791640     Document Type: Article

References (53)

1. Actavis UK Ltd. 2011. Famciclovir 250mg Tablets: Summary of Product Characteristics [online] Available at www.medicines.org.uk/emc/medicine/23952/spc
2. Aspirin Myocardial Infarction Study Research Group. 1980. A Randomized, Controlled Trial of Aspirin in Persons Recovered From Myocardial Infarction. Journal of the American Medical Association, 243: 661 - 669.
3. Bent, S. P. A. 2006. Brief Communication: Better Ways to Question Patients About Adverse Medical Events-A Randomized, Controlled Trial. Annals of Internal Medicine, 144: 257 - 261.
4. Berry, S. M. and Berry, D. A. 2004. Accounting for Multiplicities in Assessing Drug Safety: A Three-Level Hierarchical Mixture Model. Biometrics, 60: 418 - 426.
5. Chen, Z. and McGee, M. 2008. A Bayesian Approach to Zero-Numerator Problems Using Hierarchical Models. Journal of Data Science, 6: 261 - 268.
6. Chi, G., Hung, H. M. and O'Neill, R. T. 2002. Some Comments on "Adaptive Trials and Bayesian Statistics in Drug Development" by Don Berry. Pharmaceutical Report, 9: 1 - 11.
7. Chuang-Stein, C. and Beltangady, M. 2011. Reporting Cumulative Proportion of Subjects With an Adverse Event Based on Data From Multiple Studies. Pharmaceutical Statistics, 10: 3 - 7.
8. CIOMS Working Group III. 1995. Guidelines for Preparing Core Clinical-Safety Information on Drugs, Geneva: Council for International Organizations of Medical Sciences.
9. CIOMS Working Groups III and V. 1999. Guidelines for Preparing Core Clinical-Safety Information on Drugs, Geneva: Council for International Organizations of Medical Sciences.
10. Dong, M. H., Dubey, S. D., O'Neill, R. T. and Tsong, Y. 1990. Competing Risk Analysis of Life Table Data: Application to Lifetime Risk Computation. Journal of Clinical Epidemiology, 43: 1351 - 1359.
11. Downing, R. W., Rickels, K. and Meyers, F. 1970. Side Reactions in Neurotics: A Comparison of Two Methods of Assessment. Journal of Clinical Pharmacology, 10: 289 - 297.
12. European Agency for the Evaluation of Medicinal Products. 2001. Points to Consider on Application With 1. Meta-Analyses; 2. One Pivotal Study available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003657.pdf
13. European Commission: Enterprise and Industry Directorate-General. 2009. A Guideline on Summary of Product Characteristics (SmPC) available at http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf
14. FDA (U.S. Food and Drug Administration). 2002. Telecon Minutes (FDA and Merck Meeting) available at http://dida.library.ucsf.edu/pdf/xjb00a10
15. FDA (U.S. Food and Drug Administration). 2005. Guidance for Industry: Premarketing Risk Assessment available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126958.pdf
16. FDA (U.S. Food and Drug Administration). 2006. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products-Content and Format available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075057.pdf
17. FDA (U.S. Food and Drug Administration). 2008. Guidance for Industry: Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/%20Guidances/UCM071627.pdf
18. Friedman, L. M., Furberg, C. D. and DeMets, D. L. 2010. Fundamentals of Clinical Trials, New York: Springer.
19. Gaynor, J. J., Feuer, E. J., Tan, C. C., Wu, D. H., Little, C. R. Straus, D. J. 1993. On the Use of Cause-Specific Failure and Conditional Failure Probabilities: Examples From Clinical Oncology Data. Journal of the American Statistical Association, 88: 400 - 409.
20. Geisser, S. 1984. On Prior Distributions for Binary Trials. The American Statistician, 38: 244 - 251.
21. Genentech. 2010. Full Prescribing Information (Herceptin) available at http://www.gene.com/gene/products/information/pdf/herceptin-prescribing.pdf
22. Gilead. 2012. Full Prescribing Information (Letairis U.S.) available at www.gilead.com/pdf/letairis_pi.pdf
23. GlaxoSmithKline. 2013. Full Prescribing Information (Selzentry U.S.) available at http://www.viivhealthcare.com/~/media/Files/G/GlaxoSmithKline-Plc/pdfs/us_selzentry.pdf
24. Hanley, J. A. and Lippman-Hand, A. 1983. If Nothing Goes Wrong, Is Everything All Right?. Journal of the American Medical Association, 249: 1743 - 1745.
25. Hermans, L., Deblander, A., De Keyser, P., Scheys, I., Lesaffre, E. and Westelinck, K. J. 1994. At Equipotent Doses, Isradipine is Better Tolerated Than Amlodipine in Patients With Mild to Moderate Hypertension: A Double-Blind, Randomized, Parallel-Group Study. British Journal of Clinical Pharmacology, 38: 335 - 340.
26. ICH E9. 1998. Statistical Principles for Clinical Trials [online] available at http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
27. 2012. ICH-Points to Consider Working Group. MedDRA Term Selection: Points to Consider [online], available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/MedDRA/MedDRA_Documents/MedDRA_Term_Selection/Release_4.4_based_on_v.15.1/TermSelection_PTC_R4.4_October.2012.pdf.
28. Jovanovic, B. D. and Levy, P. S. 1997. A Look at the Rule of Three. The American Statistician, 51: 137 - 139.
29. Kerman, J. 2011. Neutral Noninformative and Informative Conjugate Beta and Gamma Prior Distributions. Electronic Journal of Statistics, 5: 1450 - 1470.
30. Klein, D. F. 1974. What Should the Package Insert Be?. Archives of General Psychiatry, 31: 735 - 741.
31. Kuebler, J., Vonk, R., Belmel, S., Gunselmann, W., Homering, M. Nehrdich, D. 2005. Adverse Event Analysis and MedDRA: Business as Usual or Challenge?. Drug Information Journal, 39: 63 - 72.
32. Lièvre, M., Cucherat, M. and Leizorovicz, A. 2002. Pooling, Meta-Analysis, and the Evaluation of Drug Safety. Current Controlled Trials in Cardiovascular Medicine, 3: 3 - 6.
33. Mallick, A. 2012. " From AE to ADR: Medical Aspects ". In Proceedings of the 24th Annual DIA EuroMeeting, Denmark: Copenhagen.
34. MedDRA MSSO (Medical Dictionary for Regulatory Activities Maintenance and Support Services Organisation). 2011. Introductory Guide for Standardised MedDRA Queries (SMQs) Version 14.1, Chantilly, VA: International Federation of Pharmaceutical Manufacturers and Associations.
35. MedDRA MSSO. n.d. Standardised MedDRA Queries (SMQs) available at http://www.meddramsso.com/subscriber_smq.asp
36. Mehrotra, D. V. and Adewale, A. J. 2012. Flagging Clinical Adverse Experiences: Reducing False Discoveries Without Materially Compromising Power for Detecting True Signals. Statistics in Medicine, 31: 1918 - 1930.
37. 2012. MedDRA® Data Retrieval and Presentation: Points to Consider. ICH-Endorsed Guide for MedDRA Users on Data Output [online], available at http://www.meddramsso.com/PTC/drp_ptc_r33.html.
38. MedDRA MSSO. 2005. MedDRA and Product Labeling: "Best Practices" Recommendations [online], available at http://www.meddramsso.com/files_acrobat/8381-300_Label_Best_Practices.pdf.
39. Mehrotra, D. V. and Heyse, J. F. 2004. Use of the False Discovery Rate for Evaluating Clinical Safety Data. Statistical Methods in Medical Research, 13: 227 - 238.
40. Nelson, J. C., Jatlow, P. I. and Quinlan, D. M. 1984. Subjective Complaints During Desipramine Treatment. Archives of General Psychiatry, 41: 55 - 59.
41. Nilsson, M. E. and Koke, S. C. 2001. Defining Treatment-Emergent Adverse Events With the Medical Dictionary for Regulatory Activities. Drug Information Journal, 35: 1289 - 1299.
42. O'Neill, R. T. 1988. " Assessment of Safety ". In Biopharmaceutical Statistics for Drug Development, Edited by: Peace, K. E. New York: Marcel Dekker.
43. O'Neill, R. T. The Analysis of Adverse Drug Reactions in Clinical Trials: A Basis for Communicating and Managing Risk. Proceedings of the 22nd Annual Meeting of the Society for Clinical Trials, Denver, Colorado
44. O'Neill, R. T. Exploring New Strategies for Safety Assessment and Analysis. Proceedings of the 13th International Workshop on Statistical Methodology in Clinical Research and Development, Venice, Italy
45. O'Neill, R. T. Signal Detection in Clinical Trials. Proceedings of the 19th Annual DIA Euromeeting, Vienna, Austria
46. O'Neill, R. T. 2008. A Perspective on Characterizing Benefits and Risks Derived From Clinical Trials: Can We Do More?. Drug Information Journal, 42: 235 - 245.
47. Pfizer. 2012. Full Prescribing Information (PREMPRO/PREM PHASE) available at http://labeling.pfizer.com/showlabeling.aspx?id=133
48. Sherif, B. 2007. A Comparison of Kaplan-Meier and Cumulative Incidence Estimate in the Presence or Absence of Competing Risks in Breast Cancer, Pittsburgh, PA: Graduate School of Public Health, University of Pittsburgh.
49. Siddiqui, O. 2009. Statistical Methods to Analyze Adverse Events Data of Randomized Clinical Trials. Journal of Biopharmaceutical Statistics, 19: 889 - 899.
50. Tuyl, F., Gerlach, R. and Mengersen, K. 2008. A Comparison of Bayes-Laplace, Jeffreys, and Other Priors. The American Statistician, 62: 40 - 44.
51. Wang, J. and Quartey, G. 2012. Nonparametric Estimation for Cumulative Duration of Adverse Events. Biometrical Journal, 54: 1 - 14.
52. Wernicke, J. F., Faries, D. E., Milton, D. and Weyrauch, K. 2006. Detecting Treatment Emergent Adverse Events in Clinical Trials. Drug Safety, 28: 1057 - 1063.
53. Xia, H. A., Ma, H. and Carlin, B. P. 2011. Bayesian Hierarchical Modeling for Detecting Safety Signals in Clinical Trials. Journal of Biopharmaceutical Statistics, 21: 1006 - 1029.