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.

Drifting in the Cloud

‘Cloud computing’ is a buzzword that caught my attention this week. It seems everything that was once firmly grounded – books, music, high street shops and even medical records – are drifting into the ‘cloud’. In a nutshell, this buzz concept means that users do not need to install or maintain any software themselves – all they’ll need is a computer and browser. They will harness the internet as a vast computing resource and connect to them and use them as needed.

Without realizing it, you may be a cloud user already. Facebook, Twitter, Email, YouTube, iTunes all allow electronic information to be stored and processed on computers in the ‘cloud’ and then delivered to you where and when you need it. In the healthcare industry, the web-based personal health records (PHR) is set to revolutionise communication between patients and physicians as both will be able to pull up medical records from the web.

Will pharma companies that run the clinical trials, which only tentatively shifted from ancient paper records to electronic data capture (EDC) and clinical trial management (CTM), embrace the Cloud? We are not sure.

Pharma giant Ely Lilly and Co uses Amazon’s Elastic Compute Cloud (EC2) for its R&D research. They have been ‘able to launch a 64 bit machine cluster computer working on bioinformatics sequence information, complete the work, and shut it down in 20 minutes’ and it only cost ‘$6.40’ (Dave Powers – Ely Lilly Associate Information consultant).

As pharmas seek to reduce time and cost of drug development, the demand for fully integrated, end-to-end clinical solutions will increase. Clinical cloud computing would not only enable a wide range of clinical applications to be tapped from anywhere but also allow for greater access to real-time information and enhanced collaboration between CROs and sponsors.

In relation to medical imaging, it is regrettable that many clinical sites still rely on CDs or specialised equipment to transfer DICOM images. Trial Wire was launched by IXICO as part of its effort to foster the adoption of a simple, web-based image transfer tool. Evidently, a complete cloud based image management is not available, even though its benefits are clear: reduce operational time, real-time access to trial images anywhere in the world, data sharing, enhanced collaboration, and accelerated error correction.

However, all this may just be wishful thinking. Let’s hope that pharmaceutical companies are prepared to drift into the clouds.

The Rise of Image Registration

In a typical clinical trial that makes use of imaging, a subject is often scanned multiple times over a period of weeks or months. In-order to get a precise assessment of how well the drug being tested works, you need to detect subtle changes in the patient which might have been caused by the drug. While radiologists are very skilled at detecting abnormalities in images, they are not so good at measuring change precisely. This is especially true if the changes are small, as, for example, in Alzheimer's disease where the brain shrinks by a tiny fraction each year.

The first step in comparing two images is to bring them into spatial alignment, a process referred to as registration. One of the original ways of aligning the images is to simply introduce an external marker attached to the subject such that it is easily detectable in the images. Since the early 1990s, however, computer algorithms that can register the images without using markers have been developed and these are now widely used.

The founders of IXICO, Derek Hill, Jo Hajnal, David Hawkes and Daniel Rueckert, pioneered several image registration techniques in the 1990s, and demonstrated the value of image registration in diagnosis, planning treatment and monitoring disease progression.

Here’s a few words from IXICO’s CEO, Derek Hill:

“Image registration is now such an important sub-field in medical imaging that there are now conferences dedicated to it. Two important branches of image registration are simple alignment of the images to correct for position differences (often called "rigid body") and image registration that tries to exactly map one image onto another by warping (often called "non-rigid"). In rigid-body registration, if you subtract the images after the registration, you can see areas where there has been change that may be due to disease progression or drug treatment. After non-rigid registration, however, the two images look identical and it is important to analyse the valuable information in the warps to get an indication of what has changed.

Image registration is not an end in itself but a means of making more effective use of medical images, especially where precise measurements are needed. Image registration algorithms are now commonly used in many clinical trial areas as a key step in the analysis, such as measuring brain shrinkage (atrophy) and the amount of blood flowing to cancer tumours.

However, image registration can also play a role in the trials well before making measurements, by ensuring the image data is of high quality. IXICO uses image registration algorithms to check that a subject was scanned correctly (in the right place in the scanner, and imaging the correct parts of the body), to ensure that the images with the same subject label are really of the same subject (accidental mislabelling of images is, regrettably, a common feature of clinical trials), and to detect whether scanners have gone out of calibration over time. In these situations, using registration methods on the data as soon as possible after it has been collected can enable potential bad data to be detected and dealt with before it is too late.”