Letters
Post-marketing safety studies
Authors’ reply to Fralick and Kesselheim
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1850 (Published 12 April 2017) Cite this as: BMJ 2017;357:j1850
- Angela Spelsberg, epidemiologist1,
- Ulrich Keil, professor of epidemiology and social medicine2,
- Christof Prugger, epidemiologist3
- 1Working Group on Health, Transparency International Germany, and Comprehensive Cancer Centre Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany
- 2Institute of Epidemiology and Social Medicine, University of Münster, Albert Schweitzer Campus 1, 48149 Münster, Germany
- 3Institute of Public Health, Charité-Universitätsmedizin Berlin, Seestraße 73, 13347 Berlin, Germany
- spelsberg{at}tuzac.de
We agree with Fralick and Kesselheim that “optimally designed post-marketing studies” are urgently needed.1 They recommend applying the new user active comparator design to post-marketing studies. Our finding that data obtained in the numerous ongoing industry funded studies are treated as confidential business information remains a concern.
We found considerable heterogeneity in sponsors’ approach to submitting notifications and summaries of the …
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