Clinical pharmacology studies in UK Phase 1 units: An AHPPI survey 1999-2000

Abstract

Aims: This study, conducted by the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI), was designed to determine the amount of Phase I activity in the UK in the period 1999-2000, the timelines involved for submissions to ethics committee and responses from ethics committees. Methods: A questionnaire was completed by AHPPI members from pharmaceutical companies with in-house phase I units, by Clinical Research Organisations (CRO's) and by academic centres. A few responses were also available from organisations that were not AHPPI members. Results were rendered anonymous and grouped by category. Results: The response rate was >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. Conclusions: 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 the European Union (EU) Clinical Trials Directive.