Clinical Chemistry
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Clinical Chemistry 43: 1913-1918, 1997;
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(Clinical Chemistry. 1997;43:1913-1918.)
© 1997 American Association for Clinical Chemistry, Inc.

Articles

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

Carole A. Cull, Susan E. Manleya, Irene M. Stratton, H. Andrew W. Neil, Iain S. Ross1, Rury R. Holman, Robert C. Turner and David R. Matthews

UK Prospective Diabetes Study (UKPDS) Group, Diabetes Research Laboratories, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE, UK.
1 Department of Clinical Biochemistry, Medical School Buildings, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, AB9 2ZB, UK.
a Author for correspondence. Fax 00-44-1865-723884; e-mail semanley{at}drl.ox.ac.uk

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.




The following articles in journals at HighWire Press have cited this article:


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J. Hartweg, M. Gunter, R. Perera, A. Farmer, C. Cull, C. Schalkwijk, A. Kok, H. Twaalfhoven, R. Holman, and A. Neil
Stability of Soluble Adhesion Molecules, Selectins, and C-Reactive Protein at Various Temperatures: Implications for Epidemiological and Large-Scale Clinical Studies
Clin. Chem., October 1, 2007; 53(10): 1858 - 1860.
[Abstract] [Full Text] [PDF]

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S. E. Manley, I. M. Stratton, P. M. Clark, and S. D. Luzio
Comparison of 11 Human Insulin Assays: Implications for Clinical Investigation and Research
Clin. Chem., May 1, 2007; 53(5): 922 - 932.
[Abstract] [Full Text] [PDF]

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R. Retnakaran, C. A. Cull, K. I. Thorne, A. I. Adler, R. R. Holman, and for the UKPDS Study Group
Risk Factors for Renal Dysfunction in Type 2 Diabetes: U.K. Prospective Diabetes Study 74
Diabetes, June 1, 2006; 55(6): 1832 - 1839.
[Abstract] [Full Text] [PDF]

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M. Steffes, P. Cleary, D. Goldstein, R. Little, H.-M. Wiedmeyer, C. Rohlfing, J. England, J. Bucksa, M. Nowicki, and the DCCT/EDIC Research Group
Hemoglobin A1c Measurements over Nearly Two Decades: Sustaining Comparable Values throughout the Diabetes Control and Complications Trial and the Epidemiology of Diabetes Interventions and Complications Study
Clin. Chem., April 1, 2005; 51(4): 753 - 758.
[Abstract] [Full Text] [PDF]

Home page
 Diabetes CareHome page
S. Colagiuri, C. A. Cull, and R. R. Holman
Are Lower Fasting Plasma Glucose Levels at Diagnosis of Type 2 Diabetes Associated With Improved Outcomes?: U.K. Prospective Diabetes Study 61
Diabetes Care, August 1, 2002; 25(8): 1410 - 1417.
[Abstract] [Full Text] [PDF]

Home page
 BMJHome page
I. M Stratton, A. I Adler, H A. W Neil, D. R Matthews, S. E Manley, C. A Cull, D. Hadden, R. C Turner, and R. R Holman
Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study
BMJ, August 12, 2000; 321(7258): 405 - 412.
[Abstract] [Full Text]

Home page
 JAMAHome page
R. C. Turner, C. A. Cull, V. Frighi, R. R. Holman, and for the UK Prospective Diabetes Study Group
Glycemic Control With Diet, Sulfonylurea, Metformin, or Insulin in Patients With Type 2 Diabetes Mellitus: Progressive Requirement for Multiple Therapies (UKPDS 49)
JAMA, June 2, 1999; 281(21): 2005 - 2012.
[Abstract] [Full Text] [PDF]


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