Importance and transparency of non-interventional drug studies (NIS) in selected countries: A comparison with Austria
Project leaders: Claudia Wild
Project co-operation: Nikolaus Gregor-Patera
Duration: January 2017 – April 2017
Publication: Rapid Assessment No. 7c Update2017: http://eprints.hta.lbg.ac.at/1122/
In Austria it is obligatory to register NIS in a public database. 2015 saw 251 NIS on 581 pharmaceuticals with a total planned patient enrollment of 406,831. A systematic analysis of these NIS by LBI-HTA was undertaken to learn about their scientific objectives. LBI-HTA found that – due both to deficits in reporting requirements for the public database and to only modest reporting morale and accountability to the registry – the informed public in Austria is in no position to draw well-founded conclusions on the status quo of completed and ongoing NIS from the mandatory registry.
Aim of the project:
1. To compare the status quo regarding NIS in Austria documented in the published LBI-HTA report the situation in other countries is to be reviewed:
- importance of NIS
- legal regulation of NIS
- voluntary commitments by the pharmaceutical industry and the medical profession
- public information on NIS and on the remuneration for participating physicians: availability, format, specificity
2. In addition, the Austrian NIS-registry is to be reviewed once again – almost 18 month after the initial report’s cut-off day of August 7th 2015 – to investigate the publication of then overdue and missing executive summaries of NIS-results.
1. Overview search of the internet for information sources on NIS available in English or German, followed by written contact of selected national experts with a brief questionnaire.
2. Renewed access of the public Austrian NIS-registry.
Time schedule/ milestones:
January/ February 2017: Overview internet search on “status quo NIS” in other countries, selection of relevant countries, design of short questionnaire; identification of publication of NIS-results that were missing in the Austrian NIS-registry in 2015.
February 2017: Identification of experts in the selected countries, questionnaire via e-mail, gathering of country information
March 2017: Writing up of information, completion
April 2017: Internal review
Gregor-Patera N., Schader M. and Wild, C. (2016): Non-interventional studies (NIS) in Austria. A systematic analysis. Rapid Assessment 007c.: http://eprints.hta.lbg.ac.at/1080/