Published 10 December 2008, doi:10.1136/bmj.a2919
Cite this as: BMJ 2008;337:a2919

Letters

Regulation’s threat to research

A UK problem

The first 100% of the full text of this article appears below.

The Executive Committee of the European Association for Clinical Pharmacology and Therapeutics (EACPT) recently discussed the problem of obtaining permission to undertake a clinical trial.¹ From those countries represented, the problem seemed to be predominantly an issue in the United Kingdom. Representatives of seven countries stated that clinical trials were nearly always fully approved in their country within 60 days of the application being made, and this included action by the regulatory body and any necessary approval by an ethics committee or hospital authority. This is in line with a recent paper comparing the time from application to approval of multicentre clinical trials in European countries, the United States, and Australia.²

Interestingly, the approval time in European countries following the EU clinical trials directive was longer than that in those countries that were not following it (75 v 59 days).

Cite this as: BMJ 2008;337:a2919

¹ 24105 Kiel, Germany

1. Stewart PM, Stears A, Tomlinson JW, Brown MJ. Regulation—the real threat to clinical research. BMJ 2008;337:a1732. (16 October.)[Free Full Text]
2. Heerspink HJL, Dobre D, Hillege HL, Grobbee DE, de Zeeuw D, et al. Does the European clinical trials directive really improve clinical trial approval time? Br J Clin Pharmacol 2008;66:546-50.[CrossRef][Web of Science][Medline]

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Relevant Article

Regulation—the real threat to clinical research

Paul M Stewart, Anna Stears, Jeremy W Tomlinson, and Morris J Brown
BMJ 2008 337: a1732. [Extract] [Full Text]

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