JRSM > Volume 101, Number 6 > Pp. 299-304

This Article Figures Only Full Text Full Text (PDF) Send a Quick Comment Alert me when this article is cited Alert me when Quick Comments are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Hackshaw, A. Articles by Ledermann, J. A Search for Related Content PubMed PubMed Citation Social Bookmarking                      What's this?

Setting up non-commercial clinical trials takes too long in the UK: findings from a prospective study

Allan Hackshaw Deputy Director  ¹ Hannah Farrant Trial Coordinator  ² Sue Bulley R&D Clinical Trials Manager  ³ Michael J Seckl Trial Principal Investigator  ⁴   Jonathan A Ledermann Director  ⁵

¹ Cancer Research UK & UCL Cancer Trials Centre, University College London 90 Tottenham Court Road, London W1T 4TJ
² Cancer Research UK & UCL Cancer Trials Centre, University College London 90 Tottenham Court Road, London W1T 4TJ
³ Yeovil District Hospital NHS Foundation Trust Yeovil, Somerset BA21 4AT
⁴ Lung Cancer Research Group, Hammersmith Hospitals Campus of Imperial College London Ducane Rd, London W12 ONN
⁵ Cancer Research UK & UCL Cancer Trials Centre, University College London 90 Tottenham Court Road, London W1T 4TJ

Correspondence to: Allan Hackshaw ah{at}ctc.ucl.ac.uk

Objective To evaluate the specific components of setting up a simple multicentre clinical study four years after the new UK law on clinical trials was implemented in 2004.

Design Timelines associated with activating a randomized multicentre trial in lung cancer patients using an investigational medicinal product (statins) were prospectively recorded.

Setting 84 trial centres in the UK.

Main outcome measures The time taken to go through the three stages necessary to activate a trial at a centre was examined: that is, the time from when Site Specific Information was electronically transferred to a participating centre until local research ethics committee (LREC) or research and development (R&D) approvals were obtained, and a signed Clinical Trials Site Agreement (CTSA) was received.

Results It took at least six months to obtain LREC approval in 21% of centres and R&D approval in 52% of centres. Twelve centres (14%) took at least 12 months to obtain R&D approval. 31% of centres took at least three months to return a signed CTSA. Although 52% of centres took at least six months to be activated, 13% were able to complete all three stages in two months or less.

Conclusions While some centres can activate trials relatively quickly, there is considerable variation the time taken to set up a trial, much of which is due to the delay in obtaining R&D approval. This is having a major adverse effect on UK health research. There is a national need to streamline the process for considering multi-centre non-commercial clinical trials, in particular, having fixed timelines for R&D assessment. Without this, the costs of trials will increase because of extended duration, and the time to answer a research question and alter clinical practice will be significantly prolonged.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				A Smajdor, M R Sydes, L Gelling, and M Wilkinson Applying for ethical approval for research in the United Kingdom BMJ, October 16, 2009; 339(oct16_1): b4013 - b4013. [Full Text]

				A. A Mallick and F. J. O'Callaghan Research governance delays for a multicentre non-interventional study J R Soc Med, May 1, 2009; 102(5): 195 - 198. [Abstract] [Full Text] [PDF]

				T. Coats and S Goodacre Time for D in R&D? J R Soc Med, June 1, 2008; 101(6): 268 - 269. [Full Text] [PDF]