Treatment costs associated with interventional cancer clinical trials conducted at a single UK institution over 2 years (2009–2010)

Abstract

Background:The conduct of clinical trials should be an integral part of routine patient care. Treating patients in trials incurs additional costs over and above standard of care (SOC), but the extent of the cost burden is not known. We undertook a retrospective cost attribution analysis to quantitate the treatment costs associated with cancer clinical trial protocols conducted over a 2 year period.Methods:All patients entered into oncology (non-haematology) clinical trials involving investigational medicinal products in 2009 and 2010 in a single UK institution were identified. The trial protocols on which they were treated were analysed to identify the treatment costs for the experimental arm(s) of the trial and the equivalent SOC had the patient not been entered in the trial. The treatment cost difference was calculated by subtracting the experimental treatment cost from SOC cost. For randomised trials, an average treatment cost was estimated by taking into account the number of arms and randomisation ratio. An estimate of the annual treatment costs was calculated.Results:A total of 357 adult oncology patients were treated on 53 different trial protocols: 40 phase III, 2 randomised II/III and 11 phase II design. A total of 27 trials were academic, non-commercial sponsored trials and 26 were commercial sponsored trials. When compared with SOC, the average treatment cost per patient was an excess of £431 for a non-commercial trial (range £6393 excess to £6005 saving) and a saving of £9294 for a commercial trial (range £0 to £71 480). There was an overall treatment cost saving of £388 719 in 2009 and £496 556 in 2010, largely attributable to pharmaceutical company provision of free drug supplies.Conclusion:On an average, non-commercial trial protocols were associated with a small per patient excess treatment cost, whereas commercial trials were associated with a substantially higher cost saving. Taking into account the total number of patients recruited annually, treatment of patients on clinical trial protocols was associated with considerable cost savings across both the non-commercial and commercial portfolio.

Retrospective pharmaceutical financial benefits and cost avoidance analysis of clinical trial participation in the Australian haematology setting

“…Despite mixed data from literature abroad, the Australian Clinical Trials Alliance identified that for every $1 invested into conducting clinical trials, a return of $5.80 was achieved through avoiding direct health service costs, illustrating the potential for clinical trials to deliver benefits well in excess of current government funding . This parallels our findings of clinical trials delivering over $33 million of value, which greatly exceed the staffing budget of the HRCU over the period studied.…”

The correlation between National Health Service trusts' clinical trial activity and both mortality rates and care quality commission ratings: a retrospective cross-sectional study

“…19,20 Thirdly, interventional research, which in our analyses included commercial activity, may also generate more income than contributions to observational research. 21 This in turn allows reinvestment in Trust equipment and infrastructure, or investment in staff training, for example. It is, however, unlikely that novel treatment themselves contribute solely and directly to improved mortality rates and Trust performance.…”

Estimation of Drug Cost Avoidance and Pathology Cost Avoidance through Participation in NCIC Clinical Trials Group Phase III Clinical Trials in Canada

“…The Cambridge University Hospitals NHS Foundation Trust evaluated the treatment cost difference for industry and non-industry trial therapies compared with standard-ofcare therapy 21 . An overall treatment cost saving of £388,719 in 2009 and £496,556 in 2010 was observed, largely attributable to dca.…”