Computer systems clinical trials

Abdellatif M, Reda D. A Paradox-based data collection and management system for a multi-center randomized clinical trials. Comput Methods Prog Biomed 2004 73 145-64. 

In clinical trials that solely or partially rely on paper forms and pure paper-based data collection systems, participating sites use a mail carrier to send batches of hard copies of completed forms to the coordinating center. With this approach to data, forms and computer programs are necessary to keep track of received batches of completed forms. 

The telephone is still one of the primary means of communication for clinical trial personnel. The telephone is used for both voice and digital communications. Voice communication is the normal person-to-person telephone call. Data communication with the telephone is the transmission of digital data from one location to another. Various software packages have been developed for this purpose. Using a voice modem connected to a telephone, a user on a local computer can connect to another remote computer that has a modem connected to a telephone and download or upload data files. Local and remote users can also communicate with text messages. The local computer operator can even control the remote computer for trouble-shooting or system update. 

Electronic-based data collection and management systems use various computer hardware and software technologies. Although some organizations design and develop their own systems, others purchase well-established e-clinical trials software from a wide range of vendors. 

The use of wireless computer systems has gain popularity in data collection for clinical trials. They have been used as a substitute for normal paper-based patient diaries (Koop et al. [19]) to increase data quality and shorten the time needed to close the database. They have also been used for mobile interviewing [20] and for bedside data collection [21]. In patient-directed data entry, subjects are given handheld computers to answer the trial s questions (Clarke et al. [22]). 

Computer-controlled systems [54] are commonly used in clinical trials to control dispensing and manage site inventories of trial supplies. Such systems are implemented with telephone voice-based or Internet web-based systems. 

In most cases, the data that you use for clinical trial analyses are found in some kind of computer file external to the SAS System. The data you need may be found in a permanent SAS data set, a relational database table found in Oracle or Microsoft SQL Server, a Microsoft Access or Excel file, a simple delimited ASCII text file, or even an XML file. In any case SAS provides a wide array of ways in which to import data files into SAS. We explore these tools and the advantages and disadvantages of each in this chapter. 

Before a clinical trial starts, the use of technical aids such as IVRT, remote data entry and electronic diaries has to be considered. In Section 7.5.3.3, mention will be made of the use of electronic tracking system that provide status and monitoring reports. All these systems utilise computer systems that must be validated. Double and McKendry described computer validation as the process which documents that a computer system reproducibly performs the functions it was designed to do. The document Guidance for Industry - Computerised Systems used in Clinical Trials published by the FDA in 1999 gives clear recommendations of what is required (also see Section 7.5.4.1). 

FDA issues CPG Enforcement Policy for 21 CFR Part 11 FDA publishes Computerized Systems Used in Clinical Trials FDA issues CPG Year 2000 Computer Compliance... 

The EU published its Good Clinical Practice for Trials of Medicinal Products in 1991. The U.S. had no single equivalent to the EU GCP document. Computer system requirements in the EU GCPs ineluded ... 

Stokes, T. (2001), Validating Computer Systems, Part 4 — Applied Clinical Trials, 10(2). 

Using a computer-aided model for the prediction of pseu-doallergic reactions from prospective data collected from 581 patients in a controlled clinical trial with an outdated formulation of polygeline, accurate prediction of 86% of the patients who had a systemic reaction was possible (9). The data were handled by multivariate analysis using the independence Bayes model. The predictive accuracy of other reactions was poor. A history of allergy was recorded in 26% of the patients who had systemic reactions and in 12 and 13% of the patients with no systemic or skin reactions. However, these differences were not statistically significant. 

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