Do feasibility studies contribute to, or avoid, waste in research?
Do feasibility studies contribute to, or avoid, waste in research?
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DOI：
10.1371/journal.pone.0195951
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发表时间：
2018-04-23
期刊：
影响因子：
3.7
通讯作者：
Armstrong, David
中科院分区：
文献类型：
--
作者：
Morgan, Ben;Hejdenberg, Jennie;Armstrong, David
在避免研究浪费的背景下，在临床试验之前进行可行性研究应降低将更多资源投入可能“失败”的试验的风险。然而，几乎没有证据表明可行性研究是否增加或减少了研究中的浪费。由国家卫生研究所（NIHR）资助的可行性研究对患者福利研究（RfPB）计划进行了检查，以确定有多少人发表了他们的研究结果，有多少人申请了进一步的资金进行全面试验以及这两种情况发生的时间表。共确定了截至2016年5月已关闭的120项可行性研究，并向每位主要研究者（PI）发送了一份调查问卷，其中收到了89份回复，并认为适合进行分析。根据PI自我报告的回答，共有57项可行性研究被判定为可行，20项被判定为不可行，12项被判定为不确定是否进行完整试验。RfPB方案在89项可行性研究上花费了大约1 950万磅，其中16项进一步研究随后获得了总计1 680万磅的资金。被判定为不可行的20项可行性研究可能节省了大约2000万磅的进一步研究资金，这些资金可能不会成功完成。RfPB可行性研究平均耗时31个月（范围18至48）完成，成本219，048磅（范围72，031磅至326，830磅），由RfPB可行性研究资助的平均完整试验需要42个月（范围26至55）完成和成本1，163，996磅（范围321，403磅至2，099，813）磅。可行性研究和全面试验的平均时间为72个月（范围56至91），但除此之外，平均10个月（范围-7至29）是在可行性研究结束和申请全面试验之间进行的，从申请全面审判到开始全面审判，平均需要18个月（13至28个月不等）。在89项可行性研究中，约有58%的研究结果已经发表，其余的大多数研究仍计划发表。由于所涉时间较长，一些研究仍在发表可行性结论和/或申请进行全面试验的过程中。可行性研究在避免浪费和降低更昂贵的全面试验的资金投资风险方面可能是有用的，但是存在明显的时间延迟，因此在现有的研究途径中存在一些潜在的浪费。
In the context of avoiding research waste, the conduct of a feasibility study before a clinical trial should reduce the risk that further resources will be committed to a trial that is likely to 'fail'. However, there is little evidence indicating whether feasibility studies add to or reduce waste in research. Feasibility studies funded by the National Institute for Health Research's (NIHR) Research for Patient Benefit (RfPB) programme were examined to determine how many had published their findings, how many had applied for further funding for a full trial and the timeframe in which both of these occurred. A total of 120 feasibility studies which had closed by May 2016 were identified and each Principal Investigator (PI) was sent a questionnaire of which 89 responses were received and deemed suitable for analysis. Based on self reported answers from the Pls a total of 57 feasibility studies were judged as feasible, 20 were judged not feasible and for 12 it was judged as uncertain whether a full trial was feasible. The RfPB programme had spent approximately 19.5m pound on the 89 feasibility studies of which 16 further studies had been subsequently funded to a total of 16.8m pound. The 20 feasibility studies which were judged as not feasible potentially saved up to approximately 20m pound of further research funding which would likely to have not completed successfully. The average RfPB feasibility study took 31 months (range 18 to 48) to complete and cost 219,048 pound (range 72,031 pound to 326,830) pound and the average full trial funded from an RfPB feasibility study took 42 months (range 26 to 55) to complete and cost 1,163,996 pound (range 321,403 pound to 2,099,813) pound. The average timeframe of feasibility study and full trial was 72 months (range 56 to 91), however in addition to this time an average of 10 months (range -7 to 29) was taken between the end of the feasibility study and the application for the full trial, and a further average of 18 months (range 13 to 28) between the application for the full trial and the start of the full trial. Approximately 58% of the 89 feasibility studies had published their findings with the majority of the remaining studies still planning to publish. Due to the long time frames involved a number of studies were still in the process of publishing the feasibility findings and/or applying for a full trial. Feasibility studies are potentially useful at avoiding waste and de-risking funding investments of more expensive full trials, however there is a clear time delay and therefore some potential waste in the existing research pathway.