IngentaConnect Local Clinical Trial Approval Times in the UK

Authors: Chester, Paul¹; Aalam, Sadiah²; Cooper, Pauline²; Risley, Catherine²; Dornhorst, Anne³

Source: International Journal of Pharmaceutical Medicine, Volume 20, Number 5, 2006 , pp. 317-320(4)

Abstract:

Aim: This study aimed to evaluate the impact of local approval times on the schedule of a large multicentre study in the UK.

Method: We reviewed the approval times of 178 applications that were made to the UK National Health Services Trusts (across 159 hospitals and 19 primary care trusts).

Results: The mean time for approval was 82 days; more than half the submissions (94; 53%) took longer than 60 days for a decision. The reason for taking over 60 days varied but review of the trial documentation revealed that delays occurred in the Hospital R&D Office for 25 (14%) submissions, at the hospital or primary care trust level for 14 (8%) submissions, while the investigator was responsible for 23 (13%) applications taking longer than 60 days.

Conclusion: Local submissions are a source of delayed start up in many centres participating in clinical trials; however, reasons for delay are not consistent across the applications and cannot be attributed to one specific part of the local approval process.

Keywords: Clinical trial design; Pharmaceutical industry

Document Type: Research article

Affiliations: 1: 1 Oxford Centre for Diabetes Endocrinology and Metabolism, Churchill Hospital, Oxford, England 2: 2 Kendle UK Ltd, Crowthorne, England 3: 3 Hammersmith Hospital, London, England

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