Importance and transparency of non-interventional drug studies (NIS) in selected countries: A comparison with Austria

Infografik-transparenz
Research area: HTA-methods & steering instruments

Project leaders: Claudia Wild

Project co-operation: Nikolaus Gregor-Patera
Duration: January 2017 – April 2017
Publication: Rapid Assessment No. 7c Update2017: https://eprints.aihta.at/1122/

Language: Englisch


Background:

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.

 

Methods:

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

References:

Gregor-Patera N., Schader M. and Wild, C. (2016): Non-interventional studies (NIS) in Austria. A systematic analysis. Rapid Assessment 007c.: https://eprints.aihta.at/1080/