Friday, 21 August 2009

To go electronic or not to go electronic; that is the question.

With 1.6 billion internet users, even more widespread computer users, and the fact that electronic data capture (EDC) tools have now been available for over two decades, it came to me as a surprise to find out that the majority of clinical trials are still conducted using the primitive method of paper data collection and then computerizing them – a long and drawn-out process that is prone to error.

The sceptic within the industry would point out that EDC, despite being around for two decades, has failed to greatly improve the efficiency and accuracy of clinical data capture. Needless to say, this is due to the continued reliance on paper over complete computerization, caused in part by the misconception that electronic data is difficult to validate. If EDC is to take off, the entire process would need to be streamlined and integrated rather than continue an inherently inefficient element in electronic form.

Luckily for the medical imaging industry, there is no paper-based process to replace. From experience, it is safe to say that the use of radiographic films has significantly reduced over the last 10 years. They are instead being replaced by electronic images in the industry-standard DICOM format. However, one would have thought that with the advent of the internet, these electronic data would be transferred and shared electronically. Fuelled partly by the belief that internet transfer is insecure and in part by the lack of internet connection at some clinical sites, medical images traditionally have been burned onto CDs and then couriered off. This has in turn delayed quality checks and turnaround times for further image analysis.

P&G Pharmaceutical estimated that every extra day a drug remains in clinical studies costs the sponsor at least $600,000 in lost sales. For a blockbuster drug, the daily revenue lost could reach $8 million. It is therefore in the interest of clinical trial sponsors to support better electronic processes at the various phases of clinical development to achieve greater overall efficiency. In relation to medical imaging, a web-based image management system would potentially reduce transfer costs, accelerate turnaround times and provide access to data in real time. The electronic nature of medical images means less work is needed to change sponsor attitudes towards a more web-based process, backed by strong documentation of work being conducted under FDA guidelines.

1 comment:


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