BLIPS Version One was released
exclusively to the Bilag group in 1998 as a direct replacement for their old DOS
BILAG database. It included a completely new GUI interface for the BILAG index
– monitoring of eight clinical systems – mucocutaneous, immunological,
vascular, haematological, cardiovascular, biochemical neurological,
musculoskeletal, and added new functionality recording of medication drugs and
laboratory results. The software calculation algorithm was validated for the
BILAG group by Birmingham University, by checking against their database
containing 12,000 assessments.
BLIPS Version Two in 1999 added two further
internationally recognised indices – SLICC and SF-36. Graphing of results was
introduced to the functionality, and the product became a network client-server
application.
Blips Version 3.0 was released worldwide in 2000
allowing non-BILAG clinics to obtain the tool. Version 3.0 included two more indices, SLAM-R and Selena Sledai. It was recoded in Access 97
and a 100-page user guide and helptext were added. BLIPS 3.0 is now in use in
major universities and hospitals throughout the UK, USA and Canada and as far a
field as China, Korea, Australia and the Philippines. During
2003-2005 several clinical studies were conducted using BLIPS 3.0
BLIPS Version 4.0 was released first released in a
bespoke Clinical Study version in November 2005.
It has since been used introduced in more studies in
2006. Changes included improved security and
audit trail for FDA CFR21 compliance. Demographic data screens were replaced
with Patient IDs. Sign off reports were introduced, along with the ability to
automatically email them to the Study Control centre. A system admin function
was introduced to allow Study Organisers to define which functionality would be
available to clinics during trials. Further development has enabled BLIPS
4.0 to be released in June 2006 as a standard product release, rather than
restricting it to Clinical Studies. The software calculation
algorithm was again validated by the BILAG group and
by an independent software testing consultancy.
BLIPS
is now in use in over 30 countries around the world, and since release around
200 users have registered their copies.
BLIPS
in the Future
The
BILAG group developed a revised index in 2004 which is currently undergoing
clinical validation and revision. Although this may result in a new software
product in 2007, it is not expected that it will be used in clinical trials
immediately.
The
newly released BLIPS version 4.0 product is based on the BILAG algorithm which
has been clinically validated over the last 21 years. It is expected that BLIPS
4.0 will remain the core BILAG product for the foreseeable future.
In a separate development,
ADS-Limathon have been working with Ionasys
Incorporated to develop a web enabled version of BLIPS, to be known as i-BLIPS.
Based on the BLIPS 4.0 calculation algorithm, the product retains many of the
familiar features of BLIPS, but instead of being MS Access based, it is written
in Java, and runs TOMCAT and a MYSQL database, located on a hosted server. This
will be initially aimed at Clinical Studies but it may also prove valuable to
collaborating clinics such as BILAG and SLICC. It provides the Study Organisers
all the major benefits associated with internet applications, including a
central database and a simple front end deployment in Internet Explorer. No
installation on the users PC is required. After the user has been registered in
the database, it is a simple task of entering the web address, and logging on
with a user name and password.
The development of i-BLIPS
is progressing well and a 'Proof of Concept' product is already available for
demonstration. The next steps involve testing the calculation algorithms in
order to validate the software before it can be deployed to a secure server for
use in a live study. ADS-Limathon are actively seeking to engage a
pharmaceutical sponsor to progress this project from proof of concept to a live
study environment.
Gordon Hamilton, July 2006
The
History of BLIPS
