References
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.
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.
Pacurariu A, Plueschke K, Olmo CA, Kurz X. Imposed registries within the European postmarketing surveillance system: extended analysis and lessons learned for regulators. Pharmacoepidemiol Drug Saf. 2018;27(7):823–6.
Bouvy JC, Blake K, Slattery J, De Bruin ML, Arlett P, Kurz X. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005–2013. Pharmacoepidemiol Drug Saf. 2017;26(12):1442–50.
Olmo CA, McGettigan P, Kurz X. Barriers and opportunities for use of patient registries in medicines regulation. Clin Pharmacol Ther. 2019;106(1):39–42.
Bearman M, Dawson P. Qualitative synthesis and systematic review in health professions education. Med Educ. 2013;47:252–60.
European Medicines Agency. Patient registries. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/patient-registries. Accessed 18 Sep 2019.
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.
Li G, Sajobi TT, Menon BL, et al. Registry-based randomized controlled trials—what are the advantages, challenges, and areas for future research? J Clin Epidemiol. 2016;80:16–24.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
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.
Rights and permissions
About this article
Cite this article
McGettigan, P., Olmo, C.A., Plueschke, K. et al. 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”. Drug Saf 42, 1517–1518 (2019). https://doi.org/10.1007/s40264-019-00863-w
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40264-019-00863-w