Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data

被引：78

作者：

Speich, Benjamin ^{[1
,2
]}

von Niederhaeusern, Belinda ^{[2
,3
]}

Schur, Nadine ^{[4
]}

Hemkens, Lars G. ^{[1
,2
]}

Fuerst, Thomas ^{[5
,6
]}

Bhatnagar, Neera ^{[7
]}

Alturki, Reem ^{[8
]}

Agarwal, Arnav ^{[7
,9
]}

Kasenda, Benjamin ^{[1
,2
,10
]}

Pauli-Magnus, Christiane ^{[2
,3
]}

Schwenkglenks, Matthias ^{[4
,11
]}

Briel, Matthias ^{[1
,2
,7
]}

机构：

[1] Univ Basel, Basel Inst Clin Epidemiol & Biostat, Dept Clin Res, Spitalstr 12, CH-4031 Basel, Switzerland

[2] Univ Hosp Basel, Spitalstr 12, CH-4031 Basel, Switzerland

[3] Univ Basel, Dept Clin Res, Clin Trial Unit, Basel, Switzerland

[4] Univ Basel, Inst Pharmaceut Med, Basel, Switzerland

[5] Univ Basel, Swiss Trop & Publ Hlth Inst, Dept Epidemiol & Publ Hlth, Basel, Switzerland

[6] Imperial Coll London, Sch Publ Hlth, London, England

[7] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada

[8] King Fahad Specialist Hosp Dammam, Multi Organ Transplant Ctr, POB 15215, Dammam 31444, Saudi Arabia

[9] Univ Toronto, Sch Med, Toronto, ON, Canada

[10] Univ Basel, Dept Med Oncol, Basel, Switzerland

[11] Univ Zurich, Epidemiol Biostat & Prevent Inst, Zurich, Switzerland

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 2018年 / 96卷

关键词：

Randomized clinical trials; Clinical trial cost; Cost drivers; Resource use; Systematic review; Trial feasibility; RECRUITMENT METHODS; REDUCING WASTE; PREVENTION TRIAL; DRUG DEVELOPMENT; INCREASING VALUE; PRIMARY-CARE; PATIENT RECRUITMENT; BIOMEDICAL-RESEARCH; ECONOMIC RETURN; HEALTH RESEARCH;

D O I：

10.1016/j.jclinepi.2017.12.018

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Objectives: Randomized clinical trials (RCTs) are costly. We aimed to provide a systematic overview of the available evidence on resource use and costs for RCTs to support budget planning. Study Design and Setting: We systematically searched MEDLINE, EMBASE, and HealthSTAR from inception until November 30, 2016 without language restrictions. We included any publication reporting empirical data on resource use and costs of RCTs and categorized them depending on whether they reported (i) resource and costs of all aspects at all study stages of an RCT (including conception, planning, preparation, conduct, and all tasks after the last patient has completed the RCT); (ii) on several aspects, (iii) on a single aspect (e.g., recruitment); or (iv) on overall costs for RCTs. Median costs of different recruitment strategies were calculated. Other results (e.g., overall costs) were listed descriptively. All cost data were converted into USD 2017. Results: A total of 56 articles that reported on cost or resource use of RCTs were included. None of the articles provided empirical resource use and cost data for all aspects of an entire RCT. Eight articles presented resource use and cost data on several aspects (e.g., aggregated cost data of different drug development phases, site-specific costs, selected cost components). Thirty-five articles assessed costs of one specific aspect of an RCT (i.e., 30 on recruitment; five others). The median costs per recruited patient were USD 409 (range: USD 41-6,990). Overall costs of an RCT, as provided in 16 articles, ranged from USD 43-103,254 per patient, and USD 0.2-611.5 Mio per RCT but the methodology of gathering these overall estimates remained unclear in 12 out of 16 articles (75%). Conclusion: The usefulness of the available empirical evidence on resource use and costs of RCTs is limited. Transparent and comprehensive resource use and cost data are urgently needed to support budget planning for RCTs and help improve sustainability. (C) 2017 Elsevier Inc. All rights reserved.

引用

页码：1 / 11

页数：11