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Clinical science
Predictive factors for the placebo effect in clinical trials for dry eye: a pooled analysis of three clinical trials
  1. Takahiro Imanaka1,2,
  2. Izumi Sato1,3,
  3. Shiro Tanaka1,
  4. Koji Kawakami1
  1. 1Department of Pharmacoepidemiology, Graduate School of Medicine, Kyoto University, Yoshida Konoecho, Sakyoku, Kyoto, Japan
  2. 2Research and Development Division, Santen Pharmaceutical Co., Ltd., Ofuka-cho, Kita-ku, Osaka, Japan
  3. 3The Keihanshin Consortium for Fostering the Next Generation of Global Leaders in Research (K-CONNEX)
  1. Correspondence to Professor Koji Kawakami, Department of Pharmacoepidemiology, Graduate School of Medicine, Kyoto University, Yoshida Konoecho, Sakyoku, Kyoto 606-8501, Japan; kawakami.koji.4e{at}kyoto-u.ac.jp

Footnotes

  • Acknowledgements The data set used in this research was provided by Santen Pharmaceutical Co., Ltd. This research was supported by the Keihanshin Consortium for Fostering the Next Generation of Global Leaders in Research (K-CONNEX), established by Human Resource Development Program for Science and Technology, MEXT.

  • Contributors TI obtained the data, wrote the study protocol and the statistical analysis plan, cleaned and analysed the data, and drafted and revised the paper. IS, ST and KK analysed the data, and drafted and revised the paper. KK is guarantor.

  • Competing interests TI is an employee of Santen Pharmaceutical Co., Ltd. KK received research funds from Medical Platform Co., Novartis Pharmaceutical K.K. and Bayer; honorarium from Astellas, Novartis Pharmaceutical K.K. and Sanofi K.K. There are no patents, products in development or marketed products to declare relevant to those companies. No other disclosures were reported.

  • Patient consent This was the secondary analysis using anonymised data of clinical trials. The original clinical trials were conducted on Good Clinical Practice.

  • Ethics approval The Ethics Committee of the Kyoto University School of Medicine.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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Footnotes

  • Acknowledgements The data set used in this research was provided by Santen Pharmaceutical Co., Ltd. This research was supported by the Keihanshin Consortium for Fostering the Next Generation of Global Leaders in Research (K-CONNEX), established by Human Resource Development Program for Science and Technology, MEXT.

  • Contributors TI obtained the data, wrote the study protocol and the statistical analysis plan, cleaned and analysed the data, and drafted and revised the paper. IS, ST and KK analysed the data, and drafted and revised the paper. KK is guarantor.

  • Competing interests TI is an employee of Santen Pharmaceutical Co., Ltd. KK received research funds from Medical Platform Co., Novartis Pharmaceutical K.K. and Bayer; honorarium from Astellas, Novartis Pharmaceutical K.K. and Sanofi K.K. There are no patents, products in development or marketed products to declare relevant to those companies. No other disclosures were reported.

  • Patient consent This was the secondary analysis using anonymised data of clinical trials. The original clinical trials were conducted on Good Clinical Practice.

  • Ethics approval The Ethics Committee of the Kyoto University School of Medicine.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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