Transparency: Sponsoring of continuing medical education (CME) and knowledge gain through NIS / non-interventional studies
Project leaders: Claudia Wild
Project team: Claudia Wild
& 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:
- 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?
- 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:
- Search in the CME database for sponsors in 15 (of 56) medical subjects.
- 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.