Re: Are clinical trials units essential for a successful trial?
NIHR supports 24 UKCRC registered CTUs to conduct trials funded by NIHR. We do this because we believe that involvement of CTUs has raised the quality of trials substantially, and contributes to our policy of increasing value in research (1). Prof Chetter is correct that CTUs are not essential to the successful conduct of trials – but the functions of a CTU (as described by Mr Gohel) are.
Some trial teams have all of these functions, without a formal title of a CTU and we are happy to receive applications from them. But failing to consider and demonstrate the likelihood of good trial management in an application will certainly result in its rejection. It is particularly true that many smaller trials (often phase I or II) can be managed perfectly well by an experienced team without the full engagement of a CTU. CTUs are not uniform: some provide all the essential functions, and some fewer. Nor are they a panacea: trials are always difficult and challenging, but essential for all the reasons that Mr Gohel and Prof Chetter list. NIHR is committed to supporting trials that have the potential to improve clinical practice: we see CTUs as important partners in many of these.
1. Ioannidis J, Greenland S, Hlatky M, Khoury M, McLeod M, Moher D, Schulz K, Tibshirani R. Increasing value and reducing waste in research design, conduct, and analysis. The Lancet 2014;383: 166 – 175
Competing interests: I am responsible for funding CTUs on behalf of NIHR