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Approach to maintaining comparability of biochemical data during long- term clinical trials

Approach to maintaining comparability of biochemical data during long- term clinical trials
Approach to maintaining comparability of biochemical data during long- term clinical trials

Our objective was to design a structured approach to maintaining comparability of biochemical data during a long clinical trial. Maintaining the comparability of clinical and biochemical data obtained in long-term studies is essential, even though analytical methods in the laboratory may be changed, conventions on specimen handling and storage revised, calibration procedures updated, quality-control systems replaced, and secular changes may occur. The United Kingdom Prospective Diabetes Study (UKPDS), a large randomized control trial investigating therapy for type 2 diabetes, was the setting for the study. Data were collected from 5102 subjects randomized since 1977. Our techniques included quality control, external quality assurance, direct comparison of laboratory methods when updating assays and statistical techniques for the detection of unsuspected changes in assay bias, laboratory comparisons of new with old assay methodologies, the realigning of-data to current methods, the use of a suitable reference population for long-term monitoring, and rules to aid decision-making about clinical vs statistical significance. Procedures by which comparability of data is assured should be specified for all long-term trials and, where possible, comparison with reference methods should be detailed to allow results from different laboratories to be compared.

0009-9147
1913-1918
Cull, Carole A.
ae95233f-ce25-4c32-a5b9-368419e07826
Manley, Susan E.
46bacfff-cf40-4894-86d8-4aa07e302e70
Stratton, Irene M.
772f25b9-23c0-4240-a3f6-1e76b03b172f
Neil, H. Andrew W.
ded0352b-edc2-499f-a8b9-51f82489f985
Ross, Iain S.
a0787bf0-0c46-4fb1-9a4f-8588c4845683
Holman, Rury R.
336fb2f7-edb5-4d65-a7b0-465111cbd047
Turner, Robert C.
f974acc5-a17a-49c4-8bb7-84fa4d449863
Matthews, David R.
ba1a878d-6510-45c5-896c-d4ade423caca
Cull, Carole A.
ae95233f-ce25-4c32-a5b9-368419e07826
Manley, Susan E.
46bacfff-cf40-4894-86d8-4aa07e302e70
Stratton, Irene M.
772f25b9-23c0-4240-a3f6-1e76b03b172f
Neil, H. Andrew W.
ded0352b-edc2-499f-a8b9-51f82489f985
Ross, Iain S.
a0787bf0-0c46-4fb1-9a4f-8588c4845683
Holman, Rury R.
336fb2f7-edb5-4d65-a7b0-465111cbd047
Turner, Robert C.
f974acc5-a17a-49c4-8bb7-84fa4d449863
Matthews, David R.
ba1a878d-6510-45c5-896c-d4ade423caca

Cull, Carole A., Manley, Susan E., Stratton, Irene M., Neil, H. Andrew W., Ross, Iain S., Holman, Rury R., Turner, Robert C. and Matthews, David R. (1997) Approach to maintaining comparability of biochemical data during long- term clinical trials. Clinical Chemistry, 43 (10), 1913-1918. (doi:10.1093/clinchem/43.10.1913).

Record type: Article

Abstract

Our objective was to design a structured approach to maintaining comparability of biochemical data during a long clinical trial. Maintaining the comparability of clinical and biochemical data obtained in long-term studies is essential, even though analytical methods in the laboratory may be changed, conventions on specimen handling and storage revised, calibration procedures updated, quality-control systems replaced, and secular changes may occur. The United Kingdom Prospective Diabetes Study (UKPDS), a large randomized control trial investigating therapy for type 2 diabetes, was the setting for the study. Data were collected from 5102 subjects randomized since 1977. Our techniques included quality control, external quality assurance, direct comparison of laboratory methods when updating assays and statistical techniques for the detection of unsuspected changes in assay bias, laboratory comparisons of new with old assay methodologies, the realigning of-data to current methods, the use of a suitable reference population for long-term monitoring, and rules to aid decision-making about clinical vs statistical significance. Procedures by which comparability of data is assured should be specified for all long-term trials and, where possible, comparison with reference methods should be detailed to allow results from different laboratories to be compared.

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Published date: 1997

Identifiers

Local EPrints ID: 486951
URI: http://eprints.soton.ac.uk/id/eprint/486951
ISSN: 0009-9147
PURE UUID: 973d20f4-b511-4fd9-bc33-5858b6cd1a15
ORCID for Irene M. Stratton: ORCID iD orcid.org/0000-0003-1172-7865

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Date deposited: 08 Feb 2024 17:45
Last modified: 06 Jun 2024 02:10

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Contributors

Author: Carole A. Cull
Author: Susan E. Manley
Author: Irene M. Stratton ORCID iD
Author: H. Andrew W. Neil
Author: Iain S. Ross
Author: Rury R. Holman
Author: Robert C. Turner
Author: David R. Matthews

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