Transparency: Research questions in non-interventional drug studies (NIS), Update

Research area: HTA-methods & steering instruments

Duration:  2021 (1 PM)

AIHTA - Projekt „Transparency“

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 7^th 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.