Clinical pharmacology studies in UK Phase 1 units: an AHPPI survey 1999–2000

• Published in: British journal of clinical pharmacology 2004-01, Vol.57 (1), p.76-79
• Main Authors: Calder, N., Boyce, M., Posner, J., Sciberras, D.
• Format: Article
• Language: English
• Subjects: AHPPI; Biological and medical sciences; Biomedical Research; Clinical trial. Drug monitoring; Clinical Trials, Phase I as Topic; Drug Industry - ethics; Ethics Committees, Clinical; Ethics Committees, Research; General pharmacology; Humans; Medical sciences; Pharmacoepidemiology; Pharmacology, Clinical - ethics; Pharmacology. Drug treatments; Phase I; Survey; Surveys and Questionnaires; United Kingdom
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1046/j.1365-2125.2003.01961.x

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.