This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
McGettigan P, Alonso Olmo C, Plueschke K, Castillon M, Nogueras Zondag D, 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 (Epub 13 Jul 2019).
Barnett-Page E, Thomas J. Methods for the synthesis of qualitative research: a critical review. BMC Med Res Methodol. 2009;9:59. https://doi.org/10.1186/1471-2288-9-59.
Gliklich R, Dreyer N. Registries for evaluating patient outcomes: a user’s guide. Agency for Healthcare Research and Quality; 2007.
Zaletel M, Kralj M. Methodological guidelines and recommendations for efficient and rational governance of patient registries. PARENT. 2015;25:232.
European Medicines Agency. Patient Registries. http://www.ema.europa.eu/ema/index.jsp%3fcurl%3dpages/regulation/general/general_content_000658.jsp%26mid%3dWC0b01ac0580961211. Accessed 12 Aug 2019.
REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC 2014. https://ec.europa.eu/health/human-use/clinical-trials/regulation_en. Accessed 12 Aug 2019
NIHR. National Institute for Health Research Glossary. https://www.nihr.ac.uk/about-us/glossary.htm. Accessed 12 Aug 2019
Clinical Trials.gov Glossary n.d.
Mann CJ. Observational research methods. Research design II: cohort, cross sectional, and case–control studies. Emerg Med J. 2003;20:54. https://doi.org/10.1136/emj.20.1.54.
No sources of funding were used to assist in the preparation of this letter.
Conflict of interest
Ravi Jandhyala is the managing director of Medialis Ltd, a Medical Affairs consultancy that offers consultation on clinical research as a paid service.
About this article
Cite this article
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 42, 1515–1516 (2019). https://doi.org/10.1007/s40264-019-00862-x