Gregor-Patera, N. and Wild, C. (2017): Research interests of Non-interventional studies (NIS) in Austria. Update of the systematic analysis. Rapid Rapid Assessment 007c. Update 2017.
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The study questions of non-interventional studies (NIS) in Austria were evaluated again, two years after our first report. NIS evaluate pharmaceuticals and medical devices after their marketing authorization for the approved indication in routine clinical settings. By law NIS do not have to be approved in Austria but need to be registered. A public database of NIS has to be made available to the interested public. This update shows that over time more and more summaries of final reports are being included in the public database. Most summaries are still formally incomplete. The most common research questions NIS addressed regarded effectiveness in practice and drug safety. The summaries of final reports answer their respective research questions with virtually always positive results, only 2 of 72 NIS for which summaries are in the database also report negative results. 21 of 72 NIS are also registered in international trial registries and for 13 of 72 NIS scientific publications could be identified via PubMed. The poor quality of the database (maintenance and control of content) has not improved in the two years since our initial report.
The initial report's conclusions remain unchanged: Due to both deficits in reporting requirements for the public database (e.g. documentation of research interest already at the outset of a NIS) and modest reporting morale and accountability (timely deposition of summary of research report and comprehensive as well as accurate reporting of required additional information), the informed Austrian public is left unable to make well-founded statements on completed and ongoing NIS, in spite of the considerably large patient enrolment in these studies.
|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
WB Practice of medicine > WB 340-356 Drug Administration
QV Pharmacology, toxicology, pharmacy > QV 60-370 Pharmacology
|Series Name:||Rapid Rapid Assessment 007c. Update 2017|
|Deposited on:||15 May 2017 15:26|
|Last Modified:||15 May 2017 16:03|
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