Flexible software

COMPUTER-ASSISTED clinical trials are soon going to be a completely different ballgame with a new software approach. Till now, these trials have beep stymied by the requirement to create highly specific forms and databases for each trial. One had to design a case report form- (CRF) unique to the particular trial, new data entry screens and new edit checking systems for testing the validity and consistency of data. This consumes a lot of time, and trials are often sensitive, and prone to changes in study design.

Some contract research organisations (CRO) have been using scanned CRF images as an integral part of data entry operations to dodge the problem. Scanning CRFs into the system makes them available. to a whole unit and allow several workers to enter data simultaneously. Capturing the images of the paper CRFS on the computer reduces the chance of loss or damage to the data. Scanned CRFs however, are displayed on a split screen with the standard data- entry package running on the other window. The operator, thus, has to constantly switch between the image-display window and the data-entry window which can be quite different in their layouts. This often results in transcription errors and can be rectified only through the appropriate edit-check programme - another long-drawn process.

Furthermore, the database for the analysis of data has to be constructed in advance so that the data can be entered in the appropriate fields. These study- specific databases demand a tremendous amount of programming and frequently the database has to be renewed to incorporate changes that may spring up as the study progresses. A way out is to programme a 'smart' and all encompassing database. Clinitral of Cambridge, Massachusetts and DLB Systems Recorder, Liberty Corner, New Jersey, two premier CROs in the us operate in this fashion.

The clinical data management unit of the Kendle Research Inc, in Cincinnati, Ohio, us, has developed a new software called Trial Ware which promises to do away with all the drawbacks so far encountered. The system is a Window-based operation which allows an operator to interact directly with the database through a screen which is actually a scanned image of the CRF. The data can be now typed in without looking away from the screen and this considerably reduces operator errors.

The process begins with the scanning of a blank CRF page. The operator then uses a mouse to simply drag-and- drop a box around each field in the electronic image of the CRF. What sets apart Kendle's pioneering software is that the drag-and-drop operation automatically records the 'x' and 'y' coordinates of the box in pixels to build the resulting pattern over the image. The information on each page and in each field can be conformed to the analysis database by simply ascribing the page number of the corresponding CRF. The entire database need not be completed before the data entry begins. Changes can easily be inserted by merely changing the template.

The new software promises that the next wave of clinical trials would be less expensive, more flexible and all the more quick.

Computers Science & Technology