British Bifurcation Coronary Study - Old, New and Evolving Strategies (BBC ONE)
Dendrite Clinical Systems helped to design and develop the British Bifurcation Coronary Study - Old, New and Evolving Strategies (BBC ONE), the first web-based interventional cardiology clinical trial in the United Kingdom.
The company constructed a web-based system that incorporated the clinical trial dataset. Although the dataset was quite complex, due to the design of the trial, which compared two procedures, the system was easy to use whether cardiologists or nurses entered data.
Features of the web-based system include:
- Secure access to the system - recruitment centres are sent a unique login and password, ensuring patient confidentiality.
- Automatic patient randomisation - once the inclusion and exclusion criteria are completed, a random number generator automatically randomises the patient to a treatment group.
- Web-based system - once the data is saved, unlike a paper system, it is secure and instantly retrievable.
"The web-based system means we could monitor each patient record as the trial continues. With a paper-based system one has no idea who is enrolling patients, who has put in incomplete data etc without directly monitoring them," said Dr Hildick-Smith, co-Principal Investigator of the trail (Brighton, UK). "This system allowed us to keep a track on patient randomisation and importantly, ensure centres were adhering to protocol etc."
BBC ONE is a randomised, open label, uncontrolled safety and efficacy Phase III clinical trial, designed to investigate whether a simple (provisional T stenting) or a complex strategy (crush or culotte stenting) is best for the treatment of coronary bifurcation stenoses. Inclusion criteria for the trial included patients aged >18 years who presented with a coronary bifurcation lesion requiring treatment. The exclusion criteria included cardiogenic shock, acute myocardial infarction (MI), additional type C lesion for Rx, platelets Each time a patient was enrolled the PI received an email and could access the record's and check the dataset has been completed. The trial, which started in January 2005, successfully enrolled the last of 500 patients on target in December 2007.
"Compared to the paper system, the web-based system was much more efficient, easy-to-use, simplifies the process and allows instant access to the trial database no matter what your location. If I was asked to run a trial and it was not web-based I would not do it - I would not work with a paper-based system again," added Dr Hildick-Smith.
The BBC ONE investigators announced the results at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2008.