LBI-HTA - Publications - Search - Non-interventional studies (NIS) in Austria. A systematic analysis

Gregor-Patera, N. and Schader , M. and Wild, C. (2016): Non-interventional studies (NIS) in Austria. A systematic analysis. Rapid Assessment 007c.

[img]PDF - Sie müssen einen PDF-Viewer auf Ihrem PC installiert haben wie z. B. GSview, Xpdf oder Adobe Acrobat Reader
1165Kb
[img]PDF (Addendum: Infografik Nicht-interventionelle Studien) - Sie müssen einen PDF-Viewer auf Ihrem PC installiert haben wie z. B. GSview, Xpdf oder Adobe Acrobat Reader
395Kb
Abstract

By law NIS need to be registered. The research question underlying this systematic analysis was primarily to learn about the scientific objectives of these. On the cutoff date (Aug. 7th, 2015) information available through the public database was systematically evaluated. It comprised 251 NIS on 581 pharmaceuticals with a total planned patient enrollment of 406,831. Of 33 final reports available only 8 conformed to the formal requirements. For at least 14 (and possibly up to 31) additional NIS such reports should already have been posted online. The most common research questions a NIS addressed were effectiveness in practice (efficacy) and drug safety. The addressed pharmaceuticals were mostly patented "me-too" drugs and generic drugs/biosimilars. In 31 of the 33 reports the respective research questions were answered with a positive result for the NIS. Due to both deficits in reporting requirements for the public database and a modest reporting morale/accountability, the informed public is in no position to make well-founded statements on completed and ongoing NIS.

Item Type:Rapid Assessment LBI-HTA
Keywords:Non interventional study, non-interventional study, NIS, post market authorisation study, sponsoring, seeding trials
Subjects:WA Public health > WA 525-590 Health administration and organisation
W Health professions > W 74-80 Medical economics. Health care costs
WB Practice of medicine > WB 102 Evidence-based medicine
W Health professions > W 84 Health services. Quality of health care
QV Pharmacology, toxicology, pharmacy > QV 60-370 Pharmacology
Language:German
Series Name:Rapid Assessment 007c
Deposited on:29 Jan 2016 16:20
Last Modified:04 Apr 2016 13:06

Repository Staff Only: item control page