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Clinical pharmacology studies in UK Phase 1 units: an AHPPI survey 1999–2000
Author(s) -
Calder N.,
Boyce M.,
Posner J.,
Sciberras D.
Publication year - 2004
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.2003.01961.x
Subject(s) - directive , pharmaceutical industry , legislation , european union , protocol (science) , medicine , clinical pharmacology , clinical trial , family medicine , accounting , drug industry , pharmacology , alternative medicine , business , political science , law , engineering , engineering ethics , computer science , pathology , economic policy , programming language
A comprehensive survey of UK‐based Phase 1 activity has been conducted by the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI). The survey included studies done within pharmaceutical company in‐house units, by Clinical Research Organizations (CROs) and within academic centres. While the majority of institutions were members of AHPPI, some bodies outside of the organization were also contacted. The response rate was excellent (> 98%) and indicated that the vast majority of early drug research in humans is now CRO‐based (82%). The total number of studies (as indicated by protocol numbers) was notably similar across the 2 years –629 in 1999 and 606 in 2000. Turnaround time for ethics committee review was a mean of 14 days. These data set important benchmarks for early‐phase drug research in the UK where regulatory approval is not currently required. Furthermore, the information should be used as a guide if the competitive nature of such work in the UK is to be maintained as new national legislation is implemented following publication of the European Union (EU) Clinical Trials Directive.