Computer clinical studies

Gieschke R, Reigner BG, Steimer JL. Exploring clinical study design by computer simulation based on pharmacokinetic/pharmacodynamic modelling. Int J Clin Pharmacol Ther 1997 35 469-74. 

Fig. 12.11. a Schematics of fundus camera-interfaced RRS instrument for measurement of integral MP concentrations in human clinical studies b computer monitor display showing raw Raman spectrum obtained after single measurement (left panel) and processed, scaled, spectrum obtained after subtraction of fluorescence background (right panel)... 

Validation of computer systems—The role of QA is of particular importance with respect to complying with Part 11, related to electronic records and computer validation. Clinical QA must ensure that any computerized system associated with a study is adequately validated and that the documentation for that validation is concise, complete, and available for audit. Clinical QA must provide the appropriate guidance to both the validation and information technology groups to ensure that clinical studies are not invalidated because of inadequately validated software or hardware. 

Jelliffe, R. Rodman, J. Kolb, E. "Clinical Studies with Computer-Assisted Lidocaine Infusion Regimens," Circulation, 1976, 54, 11-211. 

As an example, we can look at how data for a clinical study would be entered without networking and groupware applications. First, data entry screens would be designed and copied to a disk to be distributed to the computers where the data entry was done. The data would be entered and copied back to a disk. The disks would then be collected and merged together at some computer. The data would then be analyzed for correctness and completeness. If problems were found, the problem would be relayed back to the data entry person responsible for the problem (by a phone call, memo, or post), the work rekeyed and then re-collected and remerged. When the data entry was complete, it would be copied and handed to others for statistical analysis. 

Clinical studies may be supported by computer systems in a number of ways from data capture, data processing, production control, and document management. Some systems may be complex, others simple. Some systems may be custom-made, others based on COTS products. Whatever the character of a clinical computer system, the same basic GCP/GLP principles apply. All computer systems that play a part in the conduct or support of clinical studies intended for regulatory... 

Levine, E., Cook, L.T., Grantham, J.J. Liver cysts in autosomal-dominant polycystic kidney disease clinical and computed tomographic study. Amer. J. Roentgenol. 1985 145 229-233... 

Gieschke, R. Reigner, B.G. Steimer, J.L. Explore clinical study design by computer simulation based on pharmacoki-netic/pharmacodynamic modeling. Int. J. Pharmacol. Ther. 1997, 55, 469-474. 

To ensure that the integrity of clinical research data is maintained and that there is total agreement between the data recorded on CRFs, the data entered in the computer, the data recorded in data listings and cross-tabulations, the data entered into statistical and clinical study reports and finally the... 

Moreno and Margolis [1] developed a computer program, which could be used to calculate the DS with respect to many CaPi phases. To calculate the DS in plaque fluid, the main inorganic ions, especially the concentrations of Ca and Pi, the ionic strength and the pH have to be measured. Clinical studies... 

LCP in the plasma, indicating a wide range of DHA synthetic competence (Uauy, Mena, Wegher, Nieto, Salem, 2000). All evidence supports the ability of human fetuses/ infants to convert LNA to DHA in vivo. However, none of these studies addresses the quantitative efficacy of this process because, as with all clinical studies, sampling from blood compartments cannot be used to reliably compute the adequacy of LCP biosynthesis and incorporation for neural tissues. 

To establish a correlation between the concentrations of different kinds of nucleosides in a complex metabolic system and normal or abnormal states of human bodies, computer-aided pattern recognition methods are required (15, 16). Different kinds of pattern recognition methods based on multivariate data analysis such as principal component analysis (PCA) (8), partial least squares (16), stepwise discriminant analysis, and canonical discriminant analysis (10, 11) have been reported. Linear discriminant analysis (17, 18) and cluster analysis were also investigated (19,20). Artificial neural network (ANN) is a branch of chemometrics that resolves regression or classification problems. The applications of ANN in separation science and chemistry have been reported widely (21-23). For pattern recognition analysis in clinical study, ANN was also proven to be a promising method (8). 

Stoke, C. L. 2001. A computer model of chronic asthma with application to clinical studies Example of treatment of exercise-induced asthma. J Allergy Clin Immunol 107 933. 

Myocardial perfusion imaging with Tc-sestamibi has been evaluated by multicenter clinical studies (Wackers et al. 1989). The advantages of " Tc-sestamibi have been demonstrated in normal subjects (Marcass et al. 1990), in patients with ischemic heart disease by comparison with thallium-201 (Maisey et al. 1990 Sporn et al. 1988 Villa-nueva-Meyer et al. 1990) and validated by single-photon emission computer tomography (SPECT) (Berman et al. 1993). 

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