A costing template for commercial clinical trials run through the National Health Service has been launched by the UK Clinical Research Network.

Developed on behalf of the National Institute for Health Research, the UKCRN Costing Template applies to contract trials of pharmaceutical and biological agents in secondary care and will be used for all relevant studies intended for adoption by the NIHR Clinical Research Networks in England.

The UKCRN is working with the devolved administrations to facilitate the development of comparable systems for implementation across the UK. It also says the template is freely available to companies interested in running trials outside the NIHR networks. Moreover, costing templates for use in primary care and in studies of medical devices are in the pipeline.

The aim is to get industry contract trials in the NHS off the ground more quickly by reducing the time needed for site-by-site negotiations. The UKCRN Costing Template is based on the principles articulated in the NHS Finance Manual and is intended to provide transparency as well as greater consistency and predictability in the costing process.

It offers a clear methodology for calculating consistent and transparent prices associated with industry-sponsored studies to support both companies and the NIHR Networks, the UKCRN explains. The template will also ensure that all NHS Trusts are fully reimbursed for any activities associated with industry trials. Standard rates, acceptable to all parties, are identified for staff time, overheads, capacity-building and investigations as well as costs for departments supporting research.

Part of the thinking behind the template is to make sure that “the cost of commercial studies stays at a reasonable level to ensure the UK remains competitive in the market”, the UKCRN notes.

In the past, it points out, companies running clinical studies in the UK have often faced “widely varying” costs, depending on the location of the trial site or NHS Trust they were working with. In the majority of cases, costings were based on “estimations which led to NHS Trusts either charging too much or not being able to recoup the funding they needed for the services they were providing”.

Guidance issued in January 2005 by the National R&D Costing Initiative Working Group, a joint initiative involving the NHS R&D Forum, South West R&D Managers, the Association of the British Pharmaceutical Industry, pharmaceutical companies and the Institute of Clinical Research, addressed the methodologies used by industry and the NHS to cost commercial research.

Speaking early last year at a conference organised by the Manchester Medicines Network, however, ABPI medical director Dr Richard Tiner said 67% of the association’s member companies were using the guidance but it had not generally been taken up by NHS trusts. Meanwhile, overheads for clinical trials in the NHS had risen by 40% overall in 2006. In one instance, a trial site had doubled its overheads for a respiratory study, Dr Tiner said.

The UKCRN template is based on a specific recommendation in the Cooksey report on health research funding in the UK, which highlighted the need for a transparent and consistent national costing system for commercial research. It was developed and piloted through a collaborative process involving key stakeholders from industry, the NHS and the research community.

The template will be reviewed and updated, as required, in the light of broader experience, the UKCRN said.