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HOW HEALTH TECHNOLOGY ASSESSMENT AGENCIES ADDRESS THE ISSUE OF UNPUBLISHED DATA

Published online by Cambridge University Press:  12 March 2014

Julia Kreis
Affiliation:
Department of Health Care Management, Berlin University of Technology Institute for Quality and Efficiency in Health Care
Dimitra Panteli
Affiliation:
Department of Health Care Management, Berlin University of Technology
Reinhard Busse
Affiliation:
Department of Health Care Management, Berlin University of Technology

Abstract

Objectives: Reporting bias potentially threatens the validity of results in health technology assessment (HTA) reports. Our study aimed to explore policies and practices of HTA agencies regarding strategies to include previously unpublished data in their assessments, focusing on requests to industry for unpublished data.

Methods: We included international HTA agencies with publicly available methods papers as well as HTA reports. From the methods papers and recent reports we extracted information on requests to industry and on searches in trial registries, regulatory authority Web sites and for conference abstracts.

Results: Eighteen HTA agencies and seventy-three reports were included. Agencies’ methods papers showed variability regarding requests to industry (requests are routinely carried out in seven cases, not mentioned in six, at the discretion of HTA authors in three, and based on manufacturer applications in two), which were reflected in the reports investigated. As reporting of requests was limited, it often remained unclear whether unpublished data had been received. Searches in trial registries, at regulatory authorities or for conference abstracts are described as a routine or optional part of the search strategy in the methods papers of 9, 11, and 8 included agencies, respectively. A total of 52 percent, 39 percent, and 16 percent of reports described searches in trial registries, at regulatory agencies, and hand searching of conference proceedings.

Conclusion: International HTA agencies currently differ considerably in their efforts to address the issue of unpublished data. Requests to industry may constitute one strategy to access and include unpublished data, while agencies can learn from each other concerning successful practice.

Type
Methods
Copyright
Copyright © Cambridge University Press 2014 

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References

REFERENCES

1. Sterne, JAC, Egger, M, Moher, D, on behalf of the Cochrane Bias Methods Group. Addressing reporting biases. In: Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions. Chichester, UK: Cochrane Collaboration and John Wiley & Sons; 2008.Google Scholar
2. McGauran, N, Wieseler, B, Kreis, J, et al. Reporting bias in medical research - A narrative review. Trials. 2010;11:37.CrossRefGoogle ScholarPubMed
3. Higgins, JPT, Altman, DG, on behalf of the Cochrane Statistical Methods Group and the Cochrane Bias Methods Group. Assessing risk of bias in included studies. In: Higgins, JPT, Green, S, eds. Cochrane handbook for systematic reviews of interventions. Chichester, UK: Cochrane Collaboration and John Wiley & Sons; 2008.CrossRefGoogle Scholar
4. Song, F, Parekh, S, Hooper, L, et al. Dissemination and publication of research findings: An updated review of related biases. Health Technol Assess. 2010;14:iii, ix-xi, 1193.CrossRefGoogle ScholarPubMed
5. Eyding, D, Lelgemann, M, Grouven, U, et al. Reboxetine for acute treatment of major depression: Systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737.CrossRefGoogle ScholarPubMed
6. Godlee, F, Loder, E. Missing clinical trial data: Setting the record straight. BMJ. 2010;341:c5641.CrossRefGoogle ScholarPubMed
7. Code of Federal Regulations. Title 21 - Food and Drugs Chapter - Food and Drug Administration of Health and Human Services. Subchapter D - Drugs for Human Use. Part 314 - Applications for FDA Approval to Market a New Drug. Subpart B–ApplicationsSec. 314.50 Content and format of an application (21CFR314.50).Google Scholar
8. Wieseler, B, McGauran, N, Kaiser, T. Finding studies on reboxetine: A tale of hide and seek. BMJ. 2010;341:c4942.CrossRefGoogle ScholarPubMed
9. Laurance, J. Drug giants warned: Tell the truth on medicines. The Independent. 27.02.2008.Google Scholar
10. Depressing research. Lancet. 2004;363:1335.CrossRefGoogle Scholar
11. De Angelis, C, Drazen, JM, Frizelle, FA, et al. Clinical trial registration: A statement from the International Committee of Medical Journal Editors. Lancet. 2004;364:911912.CrossRefGoogle ScholarPubMed
12. New York State Attorney General. Settlement sets new standard for release of drug information [online]. http://www.ag.ny.gov/press-release/settlement-sets-new-standard-release-drug-information (accessed December 2, 2012).Google Scholar
13. Wood, AJ. Progress and deficiencies in the registration of clinical trials. N Engl J Med. 2009;360:824830.CrossRefGoogle ScholarPubMed
14. European Medicines Agency. About EU Clinical Trials Register [online]. https://www.clinicaltrialsregister.eu/about.html (accessed August 29, 2013).Google Scholar
15. Turner, EH. Closing a loophole in the FDA Amendments Act. Science. 2008;322:4446.CrossRefGoogle ScholarPubMed
16. Lefebvre, C, Manheimer, E, Glanville, J, on behalf of the Cochrane Information Retrieval Methods. Searching for studies. In: Higgins, JPT, Green, S, eds. Cochrane handbook for systematic reviews of interventions. Chichester, UK: Cochrane Collaboration and John Wiley & Sons; 2008.Google Scholar
17. Smith, R. What is publication? BMJ. 1999;318:142.CrossRefGoogle ScholarPubMed
18. Yank, V, Tuohy, CV, Logan, AC, et al. Comparative effectiveness of in-hospital use of recombinant factor VIIa for off-label indications vs. usual care. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 May. Report No.: 10-EHC030-EF.Google ScholarPubMed
19. Fayter, D, Corbett, M, Heirs, M, Fox, D, Eastwood, A. A systematic review of photodynamic therapy in the treatment of pre-cancerous skin conditions, Barrett's oesophagus and cancers of the biliary tract, brain, head and neck, lung, oesophagus and skin. Health Technol Assess. 2010;14:1288.CrossRefGoogle ScholarPubMed
20. Hopewell, S, McDonald, S, Clarke, M, Egger, M. Grey literature in meta-analyses of randomized trials of health care interventions. Cochrane Database Syst Rev. 2007;2:MR000010.Google Scholar
21. Smith, B, Carson, S, Fu, R, et al. Drug class review: Disease-modifying drugs for multiple sclerosis. Final update 1 report. Portland (OR): 2010. Oregon Health & Science University; 2010 Aug.Google Scholar
22. Wessling, A, Ramsberg, J. The review of antidepressants. Solna: TLV; 2008.Google Scholar
23. Metcalfe, S, Burgess, C, Laking, G, et al. Trastuzumab: Possible publication bias. Lancet. 2008;371:16461648.CrossRefGoogle ScholarPubMed
24. Buchberger, B, Follman, M, Freyer, D, et al. Bedeutung von Wachstumsfaktoren für die Behandlung von chronischen Wunden am Beispiel des diabetischen Fußulcus. Köln: DAHTA; 2010. (Schriftenreihe Health Technology Assessment).Google Scholar
25. Coleman, CI, Baker, WL, Kluger, J, et al. Comparative effectiveness of angiotensin converting enzyme inhibitors or angiotensin II receptor blockers added to standard medical therapy for treating stable ischemic heart disease. Rockville (MD): 2009. Agency for Healthcare Research and Quality (US); 2009 Oct.Google ScholarPubMed
26. Neyt, M, Van den Bruel, A, Gailly, J, Thiry, N, Devriese, S. Tiotropium in the treatment of chronic obstructive pulmonary disease: Health technology assessment. KCE reports 108C. Brussels: Belgian Health Care Knowledge Centre (KCE); 2009. (Health Technology Assessment).Google Scholar
27. Gorenoi, V, Schönermark, MP, Hagen, A. Infektionsschutz in der Knieendoprothetik. Köln: DAHTA; 2010. (Schriftenreihe Health Technology Assessment).Google Scholar
28. Medical Services Advisory Committee. Cryotherapy for recurrent prostate cancer and renal cancer: Part A – Salvage cryotherapy for recurrent or persistent prostate cancer after radiotherapy. 2009. (MSAC application 1124).Google Scholar
29. Prayle, AP, Hurley, MN, Smyth, AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: Cross sectional study. BMJ. 2012;344:d7373.CrossRefGoogle ScholarPubMed
30. 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.CrossRefGoogle ScholarPubMed
31. Drummond, MF, Schwartz, JS, Jonsson, B, et al. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care. 2008;24:244258.CrossRefGoogle ScholarPubMed
32. Moher, D, Liberati, A, Tetzlaff, J, Altman, DG, Group, P. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. Ann Intern Med. 2009;151:264269, W264.CrossRefGoogle ScholarPubMed
33. Niederstadt, C, Droste, S. Reporting and presenting information retrieval processes: The need for optimizing common practice in health technology assessment. Int J Technol Assess Health Care. 2010;26:450457.CrossRefGoogle ScholarPubMed
34. Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Selektive Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI) bei Patienten mit Depressionen: Abschlussbericht; Auftrag A05-20A; Version 1.1 [online]. 18.08.2010 (IQWiG-Berichte; Band 55). http://www.iqwig.de/download/A05–20A_Abschlussbericht_SNRI_bei_Patienten_mit_Depressionen_V1-1.pdf (accessed August 29, 2013).Google Scholar
35. Jefferson, T, Jones, MA, Doshi, P, et al. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev. 2012;1:CD008965.Google ScholarPubMed
36. Payne, D. Tamiflu: The battle for secret drug data. BMJ. 2012;345:e7303.CrossRefGoogle ScholarPubMed
37. Gesetz zur Neurordnung des Arzneimittelmarktes in der gesetzlichen Krankenversicherung (Arzneimittelmarktneuordnungsgesetz - AMNOG) vom 22. Dezember 2010. Bundesgesetzblatt Jahrgang. 2010 Teil I Nr. 67.Google Scholar
38. European Medicines Agency. European Medicines Agency widens public access to documents [online]. 30.11.2010. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/11/WC500099468.pdf (accessed August 29, 2013).Google Scholar
39. European Medicines Agency. European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information [online]. 30.04.2013. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/04/WC500142837.pdf (accessed August 29, 2013).Google Scholar
40. European Medicines Agency. Publication and access to clinical-trial data [online]. 24.06.2013. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/06/WC500144730.pdf (accessed August 29, 2013).Google Scholar
41. Godlee, F. Clinical trial data for all drugs in current use. BMJ. 2012;345:e7304.CrossRefGoogle ScholarPubMed
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