20th March 2008

Landmark BBC ONE clinical trial completes enrolment.

Dendrite Clinical Systems is pleased to announce that the British Bifurcation Coronary Study - Old, New and Evolving Strategies (BBC ONE), the first web-based interventional cardiology clinical trial in the United Kingdom, has completed enrolment. The trial, which started in January 2005, successfully enrolled the last of 500 patients on target in December 2007.

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.

"This web-based system means we can 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," added Dr Hildick-Smith. "This system has allowed us to keep a track on patient randomisation and importantly, ensure centres were adhering to protocol etc."

The development of the web-based system was relatively straightforward. Once the dataset had been established, it was handed over to Dendrite Clinical Systems who constructed a web-based system that incorporated the dataset. Whilst acknowledging that there were some minor teething problems such as page design, establishing the correct definitions etc, Dr Hildick-Smith appreciates the unique set of challenges a web-based clinical trial presents. "This is the first time such a method of data collection had been undertaken and we anticipated there would be some issues along the way. However, once these teething problems were solved the system has performed as well as, if not better than we had hoped. I think the complexity (of the system) surprised me. Due to the design of the trial (comparing two procedures) the dataset was quite complex, with convoluted questions. Having said that, the system is incredibly easy to use whether it is cardiologists or nurses who are entering the data. Once people started using it, although unfamiliar with the concept, the vast majority of the feedback was very enthusiastic and many would use such a system again."

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.

"Compared to the paper system, the web-based system is 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," concluded Dr Hildick-Smith.

"I would like to congratulate the investigators from the BBC ONE clinical trial in completing enrolment and in particular, Dr David Hildick-Smith, for his enthusiasm for this unique project,” said Dr Peter Walton, Managing Director of Dendrite Clinical Systems. “A web-based platform for data collection offers unprecedented access by PIs across multiple sites, allowing real-time supervision of patient enrolment. We hope this is the first of many web-based clinical trials that will utilise our innovative platform."

The BBC ONE investigators are hoping to announce the results at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2008.