Transparency: Sponsoring of continuing medical education (CME) and knowledge gain through NIS / non-interventional studies

Research area: HTA-methods & steering instruments

& Roland Küllinger
Duration: January 2015 - December 2015
Publication: Decision Support Document No. 87: https://eprints.aihta.at/1053/

Suggested by: self-initiated

Language: German

Background:
The disclosure of the relationship between medical professionals and industry has internationally been discussed for a long time. The influence of the industry on research, medical training and medical practice (for example product preferences) has been widely investigated and has empirically clearly demonstrated: The available evidence suggests that the financial relationship between physicians and the industry undermines an impartial, evidence-based and integrated medical practice. Hardly anyone doubts this anymore. As a consequence, medical universities - first in the US – have begun to withdraw from accepting sponsor money for medical education, also supported by the so-called "Sunshine Act" since 2010, a policy framework that makes a full disclosure of financial ties mandatory. Additionally, observational studies, so-called non-interventional studies / NIS must be registered since some years to reduce the risk of misuse (so-called seeding trials, thus NIS as marketing tools).

Research objectives and research questions:
The project has the goal to answer 2 questions:

2. To what extent is the Austrian continuing medical education (DFP training) of various special subjects funded by the industry? Which sponsors support which medical trainings?
3. Which research questions (which insight interests) do the observational studies that are registered in the NIS database have? What are the results of the NIS?

Methods:
To answer the two research questions, the following methods are used:

2. Search in the CME database for sponsors in 15 (of 56) medical subjects.
3. Analysis of projected research questions of all observational studies documented in the NIS register and the results of the (already completed) studies.

Time schedule/ milestones (in months):
01 / 2015-05 / 2015: Evaluation of the DFP database and reporting of the evaluation
11/06/2015: Presentation of the results
06 / 2015-10 / 2015: Contacting NIS study leaders, analysis of the research questions of NIS, analysis of the results documentation of (already completed) studies, reporting results.