Automated randomization systems

Automated randomization systems have been developed using voice response [44] and telephone touch-tone technology [45,46]. Others have used a preloaded password-protected system with hidden encrypted randomization files into the trial s laptop or desktop computers that are used as distributed data collection devices [47] or have developed centralized computer programs that dynamically randomize subjects [48]. 

Spence ER, Homey A. Automated telephone randomization system. Controlled Clin Trials 1999 20 2S 88S. 

OP13 Omand, K., Bowen, T.P., and Kost, G.J. (1991). Performance evaluation of the automated, random access Opus immunoassay system. Clin. Chem. 37, 1037, Abstr. 606. 

Novotny M, Bogacz J, Peters TK, Mallas T, LaFoe M, Isom L, et al. Development of an automated random/continuous access microparticle enzyme immunoassay (MEIA) for the determination of hTSH on the Abbott AxSYM automated immunoassay system. CHn Chem 1996 42 S180. 

In addition to semiautomated systems, several fully automated random-access instrumentation have been developed, which enable a high sample throughput. Both for homogeneous and heterogeneous assays equipments have been developed, whereby for the latter approach frequently magnetic particles are used as carriers. Such random-access instrumentation allows the application of individual analyte and assay types. In addition to instrumentation for FIAs, automate instrumentation for CLIAs are also available. Of course, since such fully automated systems involve roboting operations, they are rather expensive. 

Another approach used to automate the randomization process is by embedding pregenerated randomization lists in the data collection and management system. The main disadvantage of this approach is the security of the randomization lists. This can be remedied by having the system dynamically generate randomization numbers. 

Kiuchi T, Ohashi Y, Konishi M, Bandai Y, Kosuge T, Kakizoe T. A world wide web-based user interface for a data management system for use in multi-institutional clinical trials—development and experimental operation of an automated subjects registration and random allocation system. Controlled Clin Trials 1996 17 6 476-93. 

Even complex procedures can be automated, such as dialysis to clean up dirty samplers, solvent extraction, automatic distillation and on-hne UV digestion. Unhke the earlier AutoAnalyzer systems which use a purely step-wise autosampler, the TRAACS is fitted with a random-access sampler as standard. 

The random-access sampler can go to any sample cup position, any number of times, at any time during a run. This abihty to sample cups in any order and to return to sample cups more than once, allows system automation to be greatly extended. It saves time and work by allowing automatic re-run of sample(s) following off-scale peaks and also the automatic dilution and re-analysis of off-scale samples. The sampler also saves cup positions, allowing more samples and longer unattended runs. For example, one set of standards provides initial cahbration, drift correction, carry-over correction and periodic quality control. In addition, samples or standards can be sampled in repHcate form from a single cup. The random-access sampler can be controlled and either the operator or the computer can make the decision as to which cup the sampler must go to. 

The brand file and random smoking plans are central to the whole automation design philosophy. The brand file was the first segment of the system to undergo major revision when the data handhng moved from the bureau to the in-house computer. The information on the brand file not only enables an analyst to monitor certain administrative requirements on behalf of the customer, but also allows the file itself to accompHsh most of the control functions required by the data processing system. The software to drive this expanded brand file runs interactively from a terminal in the laboratory and gives the analyst the abihty to update and maintain the file, and exert a measure of control over the whole system. 

The NovaScan is presented on a PC-compatible computer equipped with standard memory and visual capabilities, and is run on a DOS-based operating system. A customized response apparatus, including a joystick, control keys, and a keypad, is recommended. Trials of the tasks chosen to be included in the test system are displayed on the computer monitor in a random manner, thereby eliminating the need for the user to focus attention among simultaneously presented tests. However, divided attention components can be added, if needed. The length of the test (i.e., number of trials presented) can be adjusted based on the demands of the test environment. Performance is evaluated in an automated fashion using a change-from-baseline approach, and the test can be administered in an automated or supervisor-controlled manner. 

Laboratory investigations play an essential role in medicine. Laboratory results are taken into consideration in about two thirds of all medical decisions in medical systems of industrialized countries today. The vast majority of clinical chemistry analyses are based on few analytical principles including photometry, ligand binding assays and potentiometry. For these standard methods complete automation has been achieved and multi-channel, random access analyzers realize several hundred analyses per instrument and hour on a very high level of user-friendliness. Consequently, clinical chemistry is very cost efficient today typically clinical chemistry analyses contribute less than 5 % of all costs of tertiary care hospitals. 

If no rational starting point for the separation of a racemate can be found, a random screening procedure has to be applied. In most cases 250 X 4 or 4.6 mm columns are used for this purpose. Modern HPLC systems often include a column switching device with up to 12 columns. Most systems have programmable software options for the set of different mobile phase compositions. Combination of UV and polarimetric detection allows even very small selectivities to be found and used as a starting point for further optimization. Commercial systems with deconvolution and optimization options are available, together with a given set of 12 different chiral stationary phases (www.pdr-chiral.com). After an initial detection of selectivity on a CSP, the mobile phase composition and additives as well as temperature have to be varied either manually or by means of an automated system. 

At this time, after more than 10 years of study, the question of whether the synthetic substrate assays are a viable substitute for the FT method monitoring remains unanswered. Most workers agree with the above request for a randomized, multicenter, blind clinical study to supply the necessary data. All results to date indicate, as expected, that there will not be a one-to-one correlation between these two functional assay systems and that new therapeutic levels will have to be carefully set for the specific amidolytic assay methods. Also there is broad agreement that the cost of the synthetic substrate test will be much higher than the current FT method (F2, C2, R3). The conversion to automated assay formats should help reduce the cost-per-... 

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