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Point/Counterpoint Editorials |

Point: Were Industry-Sponsored Roflumilast Trials Appropriate? YesRoflumilast Trials Appropriate? Yes

Samy Suissa, PhD; Klaus F. Rabe, MD, PhD
Author and Funding Information

From the Centre for Clinical Epidemiology (Dr Suissa), Jewish General Hospital, Department of Epidemiology and Biostatistics, McGill University; and LungenClinic Grosshansdorf and Department of Medicine (Dr Rabe), University Kiel, member of the German Center for Lung Research (DZL).

Correspondence to: Samy Suissa, PhD, Centre for Clinical Epidemiology, Jewish General Hospital, 3755 Cote Ste-Catherine, H4.61, Montreal, QC, H3T 1E2, Canada; e-mail: samy.suissa@mcgill.ca


Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Suissa attended an advisory meeting for a clinical trial involving roflumilast, the drug discussed in this paper, for Nycomed AG and participated in an expert panel meeting for Forest Laboratories, Inc. Dr Rabe has been and is still involved in several clinical trials involving roflumilast, has presented data on behalf of the sponsoring companies Nycomed AG and Takeda Pharmaceutical Company Limited, received financial compensation for talking at scientific meetings and taking part in the expert panels at European Medicines Agency and the US Food and Drug Administration, by Forest Laboratories, Inc, Nycomed AG, and Takeda Pharmaceutical Company Limited. Drs Suissa and Rabe hold no interest or stocks in any of the companies listed above.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;145(5):937-939. doi:10.1378/chest.14-0112
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Extract

The randomized controlled trial is the fundamental scientific design to obtain drug approval from regulatory agencies for either marketing purposes or for new indications. Although the pharmaceutical industry is obliged to run all preapproval trials, many postapproval trials are also industry sponsored, to investigate new outcomes, new indications, or safety issues. These postapproval trials have received a bad rap: It appears that a trial cannot be credible if it is industry sponsored.

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