非商业性随机临床试验的注册：利用试验注册机构监测试验数量的可行性。

Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials.

机构信息

University of Southampton, Southampton, UK.

出版信息

Trials. 2012 Aug 20;13:140. doi: 10.1186/1745-6215-13-140.

DOI:10.1186/1745-6215-13-140

PMID:22906196

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3488314/

Abstract

BACKGROUND

A 2003 survey suggested the number of noncommercial trials in the UK was declining. Formation of the NIHR in 2006 and increased research spending by the Department of Health may have increased the number of noncommercial trials but no data are available.

METHODS

Available data on UK noncommercial trials (were obtained from the two relevant registries: ISRCTN register for the UK, and US ClinicalTrials.gov. Data on each trial were sorted by start year, and compared with the: 2003 survey, and UKCRN portfolio database from 2007.

RESULTS

The number of UK noncommercial trials registered rose from 25 in 1990 to 188 in 1999, peaked at 533 in 2003, and fell back to 334 in 2009. Total trials registered was similar to but slightly above those in the 2003 survey up to 1998, then rose sharply to 2002 before falling to 2007. From 2007 to 2009 the number registered to start each year was similar to but slightly above the UKCRN database. Less than 10% of UK noncommercial trials registered with ClinGov for most years before 2005, but this rose to 35% by 2009.

CONCLUSIONS

For the periods of overlap, trial registration data provide fairly similar totals to other sources on the number of noncommercial trials starting each year. The rise and fall in the number of trials registered between 1999 and 2007 was due to those registered in the ISRCTN database as funded by NHS Trusts. After 2007, the number of trials registered as funded by NHS Trusts has fallen in the ISRCTN register but these trials may have migrated to the US ClinGov register. The total number of noncommercial trial starts, excluding those funded by NHS Trusts, has been upward since around 2002. By 2009 the two main funders were NIHR and charities. Feasibility of using registration data to monitor the number of noncommercial trials has been demonstrated but is complicated by the use of two registers and difficulties in accessing the data. We recommend an annual report on the number of noncommercial trials registering each year.

摘要

背景

2003 年的一项调查显示，英国的非商业性试验数量正在减少。2006 年国民健康保险制度研究与创新中心的成立以及卫生部研究经费投入的增加，可能增加了非商业性试验的数量，但目前尚无相关数据。

方法

从两个相关的注册处（英国 ISRCTN 注册处和美国 ClinicalTrials.gov）获取英国非商业性试验的现有数据。根据起始年份对每个试验的数据进行分类，并与 2003 年的调查以及 2007 年英国 CRN 组合数据库进行比较。

结果

英国非商业性试验的注册数量从 1990 年的 25 例增加到 1999 年的 188 例，在 2003 年达到 533 例的峰值，随后回落到 2009 年的 334 例。截至 1998 年，总注册试验数量与 2003 年的调查结果相似，但略高于调查结果，然后在 2002 年急剧上升，到 2007 年下降。2007 年至 2009 年，每年开始注册的数量与英国 CRN 数据库相似，但略高于数据库。在 2005 年之前的大部分年份，仅有不到 10%的英国非商业性试验在 ClinGov 上注册，但到 2009 年这一比例上升到 35%。

结论

在重叠期间，试验登记数据在每年开始的非商业性试验数量方面与其他来源提供的数据相当一致。1999 年至 2007 年期间登记数量的增减归因于 NHS 信托基金资助的 ISRCTN 数据库中的试验。2007 年后，ISRCTN 登记册中登记的 NHS 信托基金资助的试验数量有所下降，但这些试验可能已转移到美国 ClinGov 登记册。自 2002 年以来，不包括 NHS 信托基金资助的试验，非商业性试验开始的总数一直在增加。到 2009 年，两个主要的资助者是国民健康保险制度研究与创新中心和慈善机构。已经证明使用登记数据来监测非商业性试验数量的可行性，但由于使用了两个登记册以及获取数据的困难，该方法变得复杂。我们建议每年报告每年登记的非商业性试验数量。