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