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Research Article

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

  • Ruben G. Duijnhoven,

    Affiliations: Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands, Medicines Evaluation Board, Utrecht, the Netherlands

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  • Sabine M. J. M. Straus,

    Affiliations: Medicines Evaluation Board, Utrecht, the Netherlands, Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands

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  • June M. Raine,

    Affiliation: Medicines and Healthcare products Regulatory Agency, London, United Kingdom

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  • Anthonius de Boer,

    Affiliation: Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands

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  • Arno W. Hoes,

    Affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands

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  • Marie L. De Bruin mail

    M.L.DeBruin@uu.nl

    Affiliations: Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands, Medicines Evaluation Board, Utrecht, the Netherlands

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  • Published: March 19, 2013
  • DOI: 10.1371/journal.pmed.1001407

About the Authors

Ruben G. Duijnhoven, Anthonius de Boer, Marie L. De Bruin
Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands
Ruben G. Duijnhoven, Sabine M. J. M. Straus, Marie L. De Bruin
Medicines Evaluation Board, Utrecht, the Netherlands
Sabine M. J. M. Straus
Department of Medical Informatics, Erasmus Medical Center, Rotterdam, the Netherlands
June M. Raine
Medicines and Healthcare products Regulatory Agency, London, United Kingdom
Arno W. Hoes
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands

Corresponding Author

Email: M.L.DeBruin@uu.nl

Competing Interests

RGD and MLDB have received financial support from the Medicines Evaluation Board (MEB) under the Regulatory Science collaboration between the MEB and Utrecht University for the submitted work. SMJMS is employed by the MEB. AWH is a member of the Dutch Medicines Evaluation Board but received no funding. AWH was not involved in the decision about the funding. AdB and JMR have no relationship with the MEB. The department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, of which AdB is the chair and RGD and MLDB are employees, has received unrestricted research funding from the Netherlands Organisation for Health Research and Development (ZonMW), the Dutch Health Care Insurance Board (CVZ), the Royal Dutch Pharmacists Association (KNMP), the private-public funded Top Institute Pharma (www.tipharma.nl, includes co-funding from universities, government, and industry), the EU Innovative Medicines Initiative (IMI), EU 7th Framework Program (FP7), the Dutch Medicines Evaluation Board, and the Dutch Ministry of Health and Industry (including GlaxoSmithKline, Pfizer, and others). The authors declare no other competing interests.

Author Contributions

Conceived and designed the experiments: RGD MLDB. Performed the experiments: RGD. Analyzed the data: RGD AdB AWH MLDB. Contributed reagents/materials/analysis tools: RGD. Wrote the first draft of the manuscript: RGD. Contributed to the writing of the manuscript: RGD JMR SMJMS AdB AWH MLDB. ICMJE criteria for authorship read and met: RGD JMR SMJMS AdB AWH MLDB. Agree with manuscript results and conclusions: RGD JMR SMJMS AdB AWH MLDB. Data extraction and validation: RGD AdB MLDB.