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

Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials
Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials
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.
trial registration, noncommercial randomised clinical trials
1745-6215
140
Raftery, James
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Fairbank, Eleanor
9d0179fe-aac9-4dbb-aa04-9315602b13f6
Douet, Lisa
59d55a4e-65cb-4294-a879-650ccbdc146e
Dent, Louise
8b827763-d839-4b4b-bbf2-358a84110294
Price, Alison
43084e97-b383-4dd5-9ae9-df4fc8626e99
Milne, Ruairidh
bd90470b-bba2-49a1-aa12-f1319d78afc2
Walley, Tom
6f872c27-c3e5-4e86-93b5-7cdec09e90a6
Raftery, James
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Fairbank, Eleanor
9d0179fe-aac9-4dbb-aa04-9315602b13f6
Douet, Lisa
59d55a4e-65cb-4294-a879-650ccbdc146e
Dent, Louise
8b827763-d839-4b4b-bbf2-358a84110294
Price, Alison
43084e97-b383-4dd5-9ae9-df4fc8626e99
Milne, Ruairidh
bd90470b-bba2-49a1-aa12-f1319d78afc2
Walley, Tom
6f872c27-c3e5-4e86-93b5-7cdec09e90a6

Raftery, James, Fairbank, Eleanor, Douet, Lisa, Dent, Louise, Price, Alison, Milne, Ruairidh and Walley, Tom (2012) Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials. Trials, 13 (1), 140. (doi:10.1186/1745-6215-13-140). (PMID:22906196)

Record type: Article

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.

Full text not available from this repository.

More information

Published date: 20 August 2012
Keywords: trial registration, noncommercial randomised clinical trials
Organisations: Faculty of Medicine, Clinical Trials Unit

Identifiers

Local EPrints ID: 354845
URI: http://eprints.soton.ac.uk/id/eprint/354845
ISSN: 1745-6215
PURE UUID: 23d731a9-406e-4191-abd5-d0320cbbbb39
ORCID for Lisa Douet: ORCID iD orcid.org/0000-0003-1569-4802
ORCID for Louise Dent: ORCID iD orcid.org/0000-0001-8181-840X
ORCID for Ruairidh Milne: ORCID iD orcid.org/0000-0002-5117-4380

Catalogue record

Date deposited: 29 Jul 2013 12:48
Last modified: 20 Jul 2019 01:12

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