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Drug Safety

, Volume 42, Issue 12, pp 1517–1518 | Cite as

Authors’ Reply to Ravi Jandhyala’s Comment on “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”

  • Patricia McGettiganEmail author
  • Carla Alonso Olmo
  • Kelly Plueschke
  • Mireia Castillon
  • Daniel Zondag
  • Priya Bahri
  • Xavier Kurz
  • Peter G. M. Mol
Letter to the Editor
  • 53 Downloads

Notes

Compliance with Ethical Standards

Funding

This work was not funded.

Conflict of interest

Patricia McGettigan, Carla Alonso Olmo, Kelly Plueschke, Mireia Castillon, Daniel Zondag, Priya Bahri, Xavier Kurz and Peter Mol have no conflicts of interest that are directly relevant to the content of this letter.

References

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    McGettigan P, Alonso CO, Plueschke K, Castillon M, Nogueras DZ, Bahri P, et al. Patient registries: an underused resource for medicines evaluation: operational proposals for increasing the use of patient registries in regulatory assessments. Drug Saf. 2019.  https://doi.org/10.1007/s40264-019-00848-9.CrossRefPubMedGoogle Scholar
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    Jandhyala R. Comment on: "Patient registries: an underused resource for medicines evaluation: operational proposals for increasing the use of patient registries in regulatory assessments". Drug Saf. 2019.  https://doi.org/10.1007/s40264-019-00862-x.CrossRefPubMedGoogle Scholar
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    European Medicines Agency. Patient registries. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/patient-registries. Accessed 18 Sep 2019.
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    Lauer MS, D’Agostino RB. The randomized registry trial—the next disruptive technology in clinical research? N Engl J Med. 2013;369(17):1579–81.CrossRefGoogle Scholar
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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.William Harvey Research InstituteQueen Mary University of LondonLondonUK
  2. 2.Pharmacovigilance and Epidemiology DepartmentEuropean Medicines AgencyAmsterdamThe Netherlands
  3. 3.Department of Clinical Pharmacy and Pharmacology, University Medical Centre GroningenUniversity of GroningenGroningenThe Netherlands
  4. 4.Dutch Medicines Evaluation BoardUtrechtThe Netherlands

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