Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust and University of Cambridge, Cambridge CB2 0QQ, UK.
Br J Cancer. 2013 Oct 15;109(8):2051-7. doi: 10.1038/bjc.2013.495. Epub 2013 Sep 24.
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.
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.
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.
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.
临床试验的开展应当成为常规患者治疗的一个组成部分。在临床试验中治疗患者会产生超出标准治疗（SOC）的额外费用，但成本负担的程度尚不清楚。我们进行了一项回顾性成本归因分析，以量化在两年期间进行的癌症临床试验方案相关的治疗成本。
确定了在英国的一家机构中，于 2009 年和 2010 年入组参与涉及研究性药物的所有肿瘤学（非血液学）临床试验的患者。对他们接受的试验方案进行了分析，以确定试验的实验组（s）的治疗成本，以及如果患者未入组试验则采用的等效 SOC。通过从 SOC 成本中减去实验治疗成本来计算治疗成本差异。对于随机试验，通过考虑臂数和随机化比例来估计平均治疗成本。计算了年度治疗成本的估计值。
共有 357 名成年肿瘤患者接受了 53 项不同试验方案的治疗：40 项 III 期、2 项随机 II/III 期和 11 项 II 期设计。共有 27 项试验为学术性、非商业赞助试验，26 项为商业赞助试验。与 SOC 相比，非商业试验的每位患者的平均治疗成本超出了 431 英镑（范围为 6393 英镑的超额费用至 6005 英镑的节省），商业试验的节省了 9294 英镑（范围为 0 至 71480 英镑）。2009 年和 2010 年，整体治疗成本分别节省了 388719 英镑和 496556 英镑，这主要归因于制药公司提供的免费药物供应。
平均而言，非商业试验方案与每位患者的少量额外治疗费用相关，而商业试验则与成本的大幅节省相关。考虑到每年招募的患者总数，临床试验方案的患者治疗与非商业和商业投资组合都有相当大的成本节省。
