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Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme

Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme
Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme
Background: by 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot ‘metadata’ on clinical trials funded by the HTA programme.

Objectives: the aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility.

Data sources: published monographs and internal HTA documents.

Review methods: a database was developed,‘populated’ using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped.

Results: one hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term ‘randomised trial’ in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their
protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data.

Limitations: the study was limited by being confined to 125 randomised trials by one funder.

Conclusions: metadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here.

Funding: The National Institute for Health Research HTA programme
1-166
Raftery, James
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Young, Amanda
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Stanton, Louise
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Milne, Ruairidh
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Cook, Andrew
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Turner, David
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Davidson, Peter
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Raftery, James
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Young, Amanda
6bb7aa9c-776b-4bdd-be4e-cf67abd05652
Stanton, Louise
8b827763-d839-4b4b-bbf2-358a84110294
Milne, Ruairidh
bd90470b-bba2-49a1-aa12-f1319d78afc2
Cook, Andrew
ab9c7bb3-974a-4db9-b3c2-9942988005d5
Turner, David
39dc4dc8-88b4-4950-8bbd-c647ff110ec9
Davidson, Peter
531fc501-2ab0-4481-900e-2e7c0cc6424d

Raftery, James, Young, Amanda, Stanton, Louise, Milne, Ruairidh, Cook, Andrew, Turner, David and Davidson, Peter (2015) Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme. Health Technology Assessment, 19 (11), 1-166. (doi:10.3310/hta19110). (PMID:25671821)

Record type: Article

Abstract

Background: by 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot ‘metadata’ on clinical trials funded by the HTA programme.

Objectives: the aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility.

Data sources: published monographs and internal HTA documents.

Review methods: a database was developed,‘populated’ using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped.

Results: one hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term ‘randomised trial’ in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their
protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data.

Limitations: the study was limited by being confined to 125 randomised trials by one funder.

Conclusions: metadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here.

Funding: The National Institute for Health Research HTA programme

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More information

Accepted/In Press date: 1 January 2015
e-pub ahead of print date: 1 February 2015
Published date: 12 February 2015
Organisations: Faculty of Medicine, Clinical Trials Unit

Identifiers

Local EPrints ID: 374296
URI: http://eprints.soton.ac.uk/id/eprint/374296
PURE UUID: 6e8aeafa-3ef3-4e9c-97a9-fc9d0ac83968
ORCID for Amanda Young: ORCID iD orcid.org/0000-0002-1486-5561
ORCID for Louise Stanton: ORCID iD orcid.org/0000-0001-8181-840X
ORCID for Ruairidh Milne: ORCID iD orcid.org/0000-0002-5117-4380
ORCID for Andrew Cook: ORCID iD orcid.org/0000-0002-6680-439X
ORCID for Peter Davidson: ORCID iD orcid.org/0000-0003-0388-6356

Catalogue record

Date deposited: 13 Feb 2015 09:10
Last modified: 18 Feb 2021 17:09

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