Comment on: “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”
- 72 Downloads
I write in response to the recent article by McGettigan et al. . I would like to thank the authors for their work and respectfully ask them to respond to three areas of interest.
The first is in relation to the methodology employed in this study. The authors describe the utilisation of a “qualitative synthesis” methodology; while numerous recognised methodologies are well-established , the exact method employed in this study is not cited. Could the authors provide a citation as, without utilising a recognised scientific methodology, the work constitutes a simple summary of the four European Medicines Agency (EMA) reports and not “original research” as presented?
The second is over the choice of definitions. Definitions published in an indexed journal require stringent quality control and rely on the use of recognised research terminology. The definition of registries used by the authors, “organised systems that use observational methods to collect uniform data on a...
Compliance with Ethical Standards
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.
- 1.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).CrossRefPubMedPubMedCentralGoogle Scholar
- 3.Gliklich R, Dreyer N. Registries for evaluating patient outcomes: a user’s guide. Agency for Healthcare Research and Quality; 2007.Google Scholar
- 4.Zaletel M, Kralj M. Methodological guidelines and recommendations for efficient and rational governance of patient registries. PARENT. 2015;25:232.Google Scholar
- 5.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.
- 6.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
- 7.NIHR. National Institute for Health Research Glossary. https://www.nihr.ac.uk/about-us/glossary.htm. Accessed 12 Aug 2019
- 8.Clinical Trials.gov Glossary n.d.Google Scholar