Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

Pharmacoepidemiology and Drug Safety

Volumn 25, Issue 6, 2016, Pages 719-724

  Crépin, Sabrina ^a   Villeneuve, Claire ^a   Merle, Louis ^a  

^a LIMOGES UNIVERSITY HOSPITAL   (France)

Author keywords

clinical trials; data quality; pharmacoepidemiology; safety assessment; serious adverse event

Indexed keywords

ACCURACY; ADVERSE DRUG REACTION; ARTICLE; CLINICAL TRIAL (TOPIC); CROSS-SECTIONAL STUDY; DRUG SAFETY; LABORATORY TEST; MEDICAL HISTORY; PRIORITY JOURNAL; SERIOUS ADVERSE EVENT;

EID: 84973468795     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3982     Document Type: Article

References (28)

1. Advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) tablet. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218493.pdf [28 October ].
2. European Medicines Agency. ICH harmonised tripartite guideline E6: note for guidance on good clinical practice (PMP/ICH/135/95).
3. European Commission. Directive 2001/20/EC of the European parliament and of the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities.
4. European Commission. Communication from the commission—detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘ENTR/CT 3’). Official Journal of the European Union.
5. International conference of harmonization of technical requirements for registration of pharmaceuticals for human use. Maintenance of the ICH guidelines on clinical safety data management: data elements for transmission of individual case safety reports E2B(R2). Current Step 4 version.
6. European medicines agency-committee for medical products for human use (CHMP). Guideline on Data Monitoring Committees. Doc Ref MEA/CHMP/EWP/5872/03.
7. Mol L, Koopman M, Ottevanger PB, et al. A prospective monitoring of fatal serious adverse events (SAEs) in a Dutch Colorectal Cancer Group (DCCG) phase III trial (CAIRO) in patients with advanced colorectal cancer. Ann Oncol 2010; 21: 415–418.
8. Dorr DA, Burdon R, West DP, et al. Quality of reporting of serious adverse drug events to an institutional review board: a case study with the novel cancer agent, imatinib mesylate. Clin Cancer Res 2009; 15: 3850–3855.
9. Mol L, Koopman M, Ottevanger PB, et al. A prospective monitoring of fatal serious adverse events (SAEs) in a Dutch Colorectal Cancer Group (DCCG) phase III trial (CAIRO) in patients with advanced colorectal cancer. Ann Oncol 2010; 21:415–418.
10. Bennett CL, Nebeker JR, Yarnold PR, et al. Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Arch Intern Med 2007; 167: 1041–1049.
11. Bandekar MS, Anwikar SR, Kshirsagar NA. Quality check of spontaneous adverse drug reaction reporting forms of different countries. Pharmacoepidemiol Drug Saf 2010; 19: 1181–1185.
12. Bergvall T, Noren GN, Lindquist M. vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf 2014; 37: 65–77.
13. Brajovic S, Piazza-Hepp T, Swartz L, et al. Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. Pharmacoepidemiol Drug Saf 2012; 21: 565–570; discussion 571–572.
14. Edwards IR, Lindquist M, Wiholm BE, et al. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990; 336: 156–158.
15. Gedde-Dahl A, Harg P, Stenberg-Nilsen H, et al. Characteristics and quality of adverse drug reaction reports by pharmacists in Norway. Pharmacoepidemiol Drug Saf 2007; 16: 999–1005.
16. Lindquist M. Data quality management in pharmacovigilance. Drug Saf 2004; 27: 857–870.
17. Sanchez-Sanchez B, Altagracia-Martinez M, Kravzov-Jinich J, et al. Evaluation of completeness of suspected adverse drug reaction reports submitted to the Mexican national pharmacovigilance centre: a cross-sectional period-prevalence study. Drug Saf 2012; 35: 837–844.
18. Vandenbroucke JP. In defense of case reports and case series. Ann Intern Med 2001; 134: 330–334.
19. Ferner RE. Newly licensed drugs. BMJ 1996; 313: 1157–1158.
20. CIOMS. CIOMS VI—management of safety information from clinical trials. 2005.
21. Bennett CL, Tigue CC, Angelotta C, et al. Adverse effects of drugs used to treat hematologic malignancies: surveillance efforts from the research on adverse drug events and reports project. Semin Thromb Hemost 2007; 33: 365–372.
22. Toneatti C, Saidi Y, Meiffredy V, et al. Experience using MedDRA for global events coding in HIV clinical trials. Contemp Clin Trials 2006; 27: 13–22.
23. Lindquist M. Seeing and Observing in International Pharmacovigilance—Achieving and Prospects in Worldwide Drug Safety. University of Nijmegen: Nijmegen, 2003.
24. Maintenance and Support Services Organization (MSSO). MedDRA term selection: points to consider (MTS: PTC). Release 4.8, Based on MedDRA Version 17.1.
25. Bolland MJ, Barber A, Doughty RN, et al. Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial. BMJ Open 2013; 3:e002334.doi:10.1136/bmjopen-2012-002334.
26. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29: 385–396.
27. Rosebraugh CJ, Tsong Y, Zhou F, et al. Improving the quality of adverse drug reaction reporting by 4th-year medical students. Pharmacoepidemiol Drug Saf 2003; 12: 97–101.
28. Belknap SM, Georgopoulos CH, West DP, et al. Quality of methods for assessing and reporting serious adverse events in clinical trials of cancer drugs. Clin Pharmacol Ther 2010; 88: 231–236.