Abstract
Studies in volunteers are most important in the research and development of a medicinal product or, as defined by the FDA (see below), of a drug. Clinical trials in humans can be performed only if preceding toxicological studies and practical considerations rule out a risk for the subjects/patients. The tests provide evidence of safety, efficacy (drugs), and thresholds. Many regulations, such as insurance, privacy, and ethics committee, must be observed.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) (2005) Federal institute for drugs and medical devices, created 15 Apr 2005, updated 16 Jan 2007. http://www.bfarm.de/EN/drugs/drugs-node-en.html. Accessed 1 Nov 2012
EudraCT (European Union Drug Regulating Authorities Clinical Trials) (2012) last updated 9 Oct 2012. https://eudract.ema.europa.eu. Accessed 1 Nov 2012
European Medicines Agency (EMEA) (2007a) Guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products, CHMP/SWP/28367/2007. http://www.ema.europa.eu/pdfs/human/swp/2836707en.pdf. Accessed 3 Nov 2012
European Medicines Agency (EMEA) (2007b) Strategies to identify and mitigate risks for first-inhuman clinical trials with investigational medicinal products, CHMP/SWP/28367/07. http://www.ema.europa.eu/pdfs/human/swp/2836707enfin.pdf. Accessed 11 Jan 2010
European Union (2005) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:091:0013:0019:EN:PDF. Accessed 1 Nov 2012
FDA U.S. Food and Drug Administration (2012) Is it a cosmetic, a drug, or both? (or is it soap?), created 8 July 2002, updated 30 Apr 2012. http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm. Accessed 28 Oct 2012
ICH-GCP (2012) International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use, Good clinical practice. http://ichgcp.net. Accessed 1 Nov 2012
Kenter MJ, Cohen AF (2006) Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet 368:1387–1391
Marchetti S, Schellens JHM (2007) The impact of FDA and EMEA guidelines on drug development in relation to phase 0 trials. Br J Cancer 97:577–581
Munos B (2009) Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov 8:959–968
Pasqualetti G, Gori G, Blandizzi C, Del Tacca M (2010) Healthy volunteers and early phases of clinical experimentation. Eur J Clin Pharmacol 66:647–653
Rang HP, Dale MM, Ritter JM, Flower RJ, Henderson G (eds) (2012) Rang and Dale’s pharmacology, 7th edn. Elsevier Churchill Livingstone, Edinburgh, Chapter 60: Drug discovery and development
U.S. National Library of Medicine (NLM) (2008) Clinical trial phases (last reviewed and updated 18 Apr 2008). http://www.nlm.nih.gov/services/ctphases.html. Accessed 1 Nov 2012
Recommended Reading
Dowsing T, Kendall MJ (2007) The Northwick Park tragedy–protecting healthy volunteers in future first-in-man trials. J Clin Pharm Ther 32:203–207
World Medical Association (2008) WMA Declaration of Helsinki – ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/index.html. Accessed 3 Nov 2012
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer-Verlag Berlin Heidelberg
About this entry
Cite this entry
Mörike, K. (2014). Studies in Volunteers and Its Regulation. In: Reichl, FX., Schwenk, M. (eds) Regulatory Toxicology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-35374-1_43
Download citation
DOI: https://doi.org/10.1007/978-3-642-35374-1_43
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-35373-4
Online ISBN: 978-3-642-35374-1
eBook Packages: Biomedical and Life SciencesReference Module Biomedical and Life Sciences