检查临床试验的可行性过程及其对试验地点的影响

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Open Access Journal of Clinical Trials Pub Date : 2011-09-09 DOI:10.2147/OAJCT.S23631
L. Burgess, L. Burgess, N. Sulzer
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引用次数: 7

摘要

通信:LJ Burgess TREAD研究/心脏病科,内科,Tygerberg医院和Stellenbosch大学,Parow 7505,南非电话+27 21 931 7825传真+27 21 933 3597电子邮件lesley@treadresearch.com目的:回顾性分析可行性问卷,以评估导致患者入组的试验数量和涉及的平均时间框架。方法:本研究于2004年1月至2009年12月由位于南非西开普省的现场管理组织TREAD Research进行。对这段时间内收到的所有可行性调查问卷进行了分析。采用描述性统计对数据进行分析。结果:共收到可行性问卷252份;207人被接受,45人被拒绝。平均有26.8%的试验是从网站接受的可行性开始的。从可行性接受到患者入组的平均时间为12.9个月(范围2.7-33.5个月)。结论:改进试验可行性流程可显著提高试验点有效规划和合理分配资源的能力。
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Examining the clinical trial feasibility process and its implications for a trial site
Correspondence: LJ Burgess TREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow 7505, South Africa Tel +27 21 931 7825 Fax +27 21 933 3597 Email lesley@treadresearch.com Objectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved. Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data. Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.7–33.5 months). Conclusion: Improving the trial feasibility process would markedly improve a trial site’s ability to plan effectively and efficiently allocate appropriate resources.
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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