The sheer complexity of clinical trials, from both a medical and statistical perspective,
makes protocol authoring both difficult and time-consuming.
A variety skills and substantial knowledge are required to design a clinical
trial: trial designers have to consult a wide variety of resources,
including specialist and general medical texts, statisticians, doctors
and pharmacists.
Further, trial designers may
have limited research experience and statistical skills and limited
access to statistical expertise (especially in the academic arena). All this has meant
that in practice, trial protocols are sometimes poorly designed and contain errors with
details often omitted and/or incorrect.
Design-a-Trial is a decision support system to assist in the design of
clinical trials. The main aim of Design-a-Trial is to help trial designers
with limited statistical and research experience to design scientifically
and ethically sound trials. It also serves as a checklist for the more
experienced designers and can be used to assist in the training
of new clinical researchers.
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DaT screen: example advice message
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DaT screen: example data entry form
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DaT screen: generated clinical trial protocol
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DaT screen: generated ethics application form
status
The first prototype of Design-a-Trial was produced in a collaboration between the National Heart & Lung Institute(Jeremy Wyatt, Charles Pantin) and IBM Scientific Centre, Winchester (Rod Cuff) with Prof. Doug Altman, Oxfordproviding trial design expertise. Later versions were produced under a UK Research Council funded project by theKnowledge Management Centre at University College, London(Jeremy Wyatt, Henry Potts) and the Biomedical InformaticsUnit at the Eastman Dental Institute (Peter Hammond, Sanjay Modgil). In 2001,
InferMed and UCL won support from the Teaching Company Scheme
to commercialise Design-a-Trial.
Design-a-Trial 4.0 was launched as a commercial product in September 2003.
Awards
Design-a-Trial won the
Best Refereed Application Paper
Award at AI-2003 (23rd Annual International Conference of the British Computer Society's Specialist Group on Artificial Intelligence (SGAI), Cambridge, December 2003).
The award was sponsored by the British Government's Department of Trade and Industry.
links
Design-a-Trial product sheet from InferMed
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