Wright James R, Roche Kathie, Smuck Bobbi, Cormier Janet, Cecchetto Suzanne, Akow Marisa, Pilatzke Susan, Pritchard Kathleen I
Juravinski Cancer Center, Hamilton Health Sciences, 699 Concession St, Hamilton, Ontario, Canada, L8V 5C2.
Contemp Clin Trials. 2005 Aug;26(4):421-9. doi: 10.1016/j.cct.2005.03.003.
The financial implications of conducting clinical trials in oncology have not been well researched from a perspective that would facilitate the negotiation of appropriate reimbursement. A better understanding of the resources required to conduct clinical trials is central to this process. Summaries of two hypothetical clinical trials were circulated to the clinical trials departments of the nine regional cancer centres of Cancer Care Ontario (CCO), in the Province of Ontario, Canada. The centres were asked to produce itemized budgets with per patient charges detailed for each trial. Additionally, each trial was to be separately considered as if sponsored by a federally funded cooperative group, and then as if sponsored by industry. Six of the centres reported experience generating clinical trial budgets. Specific charges by the local Institutional Review or Research Ethics Boards (REB) were not included. The total of all per patient charges for the first trial ranged from 1352 dollars to 3082 dollars when considered as a cooperative group trial, and from 1700 dollars to 7217 dollars when considered as an industry sponsored trial. Similar charges for the second trial ranged from 2251 dollars to 5826 dollars and from 2251 dollars to 11,304 dollars respectively. Despite the similarities of the regional cancer centres across the province of Ontario, there were surprisingly large differences in the submitted budgets. No centre consistently produced the highest or lowest estimates. The majority of the differences appeared to be based on the range in estimates for professional support (nurse and physician), and the required radiology investigations. For centres that negotiate specific per patient funding amounts with industry, this data would suggest a need to better understand the budgeting process and its link to appropriate resource identification to ensure appropriate funding is obtained. These issues are likely not unique to oncology.
从有助于协商适当报销的角度来看，肿瘤学临床试验的财务影响尚未得到充分研究。更好地了解开展临床试验所需的资源是这一过程的核心。两份假设性临床试验的摘要被分发给了加拿大安大略省癌症护理中心（CCO）九个地区癌症中心的临床试验部门。这些中心被要求编制详细列出每项试验每位患者费用的分项预算。此外，每项试验要分别被视为由联邦资助的合作组赞助，然后再视为由行业赞助。六个中心报告了编制临床试验预算的经验。当地机构审查或研究伦理委员会（REB）的具体收费未包括在内。第一项试验作为合作组试验时，每位患者的总费用在1352美元至3082美元之间，作为行业赞助试验时则在1700美元至7217美元之间。第二项试验的类似费用分别在2251美元至5826美元之间和2251美元至11304美元之间。尽管安大略省各地的地区癌症中心有相似之处，但提交预算中的差异却大得出奇。没有一个中心始终给出最高或最低估计值。大多数差异似乎基于专业支持（护士和医生）估计范围以及所需的放射学检查。对于那些与行业协商每位患者具体资金数额的中心而言，这些数据表明有必要更好地了解预算编制过程及其与适当资源识别的联系，以确保获得适当的资金。这些问题可能并非肿瘤学所特有。
