Key Points
-
Highlights that planning and conducting a clinical trial is a lengthy process that must adhere to stringent regulations to ensure a high standard of ethics and reliability.
-
Explains that clinical trials are divided into multiple phases; regulatory approval must be obtained for each one.
-
Highlights that seeking approval is usually done after writing the protocol, securing funding and sponsorship, and appointing roles and responsibilities for members of the research team.
-
Highlights that in the UK, a unified application system is available to simplify the process of applying for regulatory approval.
Abstract
Seeking regulatory and ethical approval is a significant task that must be completed before conducting a clinical trial of a medical device. Currently in the UK, the Integrated Research Application System (IRAS) is a unified system for preparing regulatory, ethical and governance applications for the relevant bodies that must approve health and social research. This article outlines key aspects in planning a clinical trial of a medical device and how applications for approval can be prepared using IRAS.
Similar content being viewed by others
Log in or create a free account to read this content
Gain free access to this article, as well as selected content from this journal and more on nature.com
or
References
Kerr D J, Knox K, Robertson D, Stewart D, Watson R . Clinical trials explained: A guide to clinical trials in the NHS for healthcare professionals. John Wiley & Sons, 2008.
Medicines and Healthcare products Regulatory Agency. Notify MHRA about a clinical investigation for a medical device. 2018. Available at https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device (accessed February 2018).
Abozguia K, Phan T T, Shivu G N, Maher A, Ahmed I, Frenneaux M P . Insights into how to conduct a clinical trial in the UK. J R Soc Med 2007; 100: 469–472.
Silverman R, Kwiatkowski T . Research fundamentals: III. elements of a research protocol for clinical trials. Acad Emerg Med 1998; 5: 1218–1223.
Chan A W, Tetzlaff J M, Altman D G et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158: 200–207.
Health Research Authority. Protocol. 2017. Available at https://www.hra.nhs.uk/planning-and-improving-research/research-planning/protocol/ (accessed February 2018).
Ehrhardt S, Appel L J, Meinert C L . Trends in National Institutes of Health Funding for Clinical Trials Registered in ClinicalTrials.gov. JAMA 2015; 314: 2566–2567.
Health Research Authority. Research Funding. 2017. Available at https://www.hra.nhs.uk/planning-and-improving-research/research-planning/funding/ (accessed August 2017).
National Institute for Health Research. Study support services. Available at https://www.nihr.ac.uk/funding-and-support/study-support-service/ (accessed February 2018).
Department of Health and Social Care. Attributing the costs of health and social care Research & Development (AcoRD). 2012. Available at https://www.gov.uk/government/news/attributing-the-costs-of-health-social-care-research-development-acord (accessed February 2018).
NHS Research and Development Forum. National Directory of NHS Research Offices. Available at http://www.rdforum.nhs.uk/content/contact-details/ (accessed February 2018).
Health Research Authority, Department of Health (England), Ireland) DoHN, Scottish Government Health and Social Care Directorates, (Wales) DfHaSS. UK policy framework for health and social care research. 2018.
Kjaergard L L, Als-Nielsen B. Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ 2002; 325: 249.
Lexchin J, Bero L A, Djulbegovic B, Clark O . Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003; 326: 1167–1170.
Integrated Research Application System. Site specific information. 2017. Available at https://www.myresearchproject.org.uk/help/hlpsitespecific.aspx (accessed February 2018).
Department for Business Energy & Industrial Strategy. CE Marking. 2012. Available at https://www.gov.uk/guidance/ce-marking (accessed July 2018).
Health Research Authority. Research Ethics Committee – Standard Operating Procedures. 2016.
Smajdor A, Sydes M R, Gelling L, Wilkinson M . Applying for ethical approval for research in the United Kingdom. BMJ 2009; 339: b4013.
Health Research Authority. Integrated Research Application System (IRAS). 2017. Available at https://www.myresearchproject.org.uk/ (accessed February 2018).
Integrated Research Application System. Using IRAS. Available at https://www.myresearchproject.org.uk/Help/HelpPage.aspx (accessed February 2018).
Health Research Authority, Medical Research Council. Is my study research? Available at http://www.hra-decisiontools.org.uk/research/ (accessed February 2018).
Health Research Authority. Research Summaries. Available at https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ (accessed February 2018).
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Ria, S., Bakir, A., Abeysiri, S. et al. Applying for regulatory approval of a clinical trial of a medical device in the UK – A practical guide. Br Dent J 225, 1033–1036 (2018). https://doi.org/10.1038/sj.bdj.2018.1033
Accepted:
Published:
Version of record:
Issue date:
DOI: https://doi.org/10.1038/sj.bdj.2018.1033
