Innovating cardiac safety trials with new technology

NGP asked Tosja K. Zywietz, Managing Director of Biosigna – Medical Diagnostics, how innovative technology will drive the future of the cardiac safety industry.

Since the publication of the FDA guidelines for cardiac safety studies (thorough QT/QTc-Studies), ECG technology to monitor patients during drug safety studies has experienced a remarkable revival. However, technology wise, there has been little innovation in this field for many years. While automation and web-technology is routinely applied in most other industries, surprisingly the clinical trial industry still relies a lot on paper based processes and human data analysis and interpretation.

NGP. What are currently the most important trends in the cardiac safety industry?
TKZ. It is obvious that the market for cardiac safety has grown significantly over recent years. Nevertheless, the growth has slowed down, and not all growth expectations were met. At the same time, competition increased significantly – many new core labs entered the market, all providing more or less the same cardiac safety services, applying the same standard technology. Interestingly, technology wise there has been only little innovation driving the industry.
Due to the challenges some of the traditional core labs were facing it seems that the industry realises that innovative technology is necessary to successfully survive and grow in this competitive market.

NGP. What is the reason for the lack of innovation in technologies for cardiac safety studies?
TKZ. First of all, equipment manufactures have always focused on the classical health care market (hospitals, GP’s etc.), not realising the clinical trial industry needs specialised products. Second, is that all technology applied directly to patients (such as ECG) during clinical trials have to fulfil an extremely high level of security and compliance. Validating new methods and procedures is therefore expensive and takes time. Naturally, the industry applied ‘old’ but well validated technology, instead of spending ‘big money’ for innovation, which would have required new FDA approval. However, there have been doubts about the accuracy and reproducibility of the manual methods of over-reading currently applied. One major problem is the so called inter- and intra-reader variability of humans, e.g., for analysing ECGs. So far, there have been no real alternatives.

NGP. How can innovative technology help to improve accuracy and reliability of cardiac safety studies?
TKZ. So far, mainly standard systems, designed to fulfil the needs of hospitals, were applied in clinical trials. Naturally, these systems do not always meet the specific requirements, especially in terms of reproducibility and accuracy. That is one reason, why most of the data analysis and validation is still done manually. Humans have a great ability for pattern recognition and it is out of question, that for the final analysis of clinical data, the human reader is vital.

However, a large part of trial data could be pre-analysed by expert systems. For this, the first step will be to develop completely electronic data capturing systems, which allow a seamless process of data acquisition, transmission to the expert system, and analysis with, for example, intelligent algorithms. Only the final step will be (electronic based) approval of data by human readers. It is for sure, that such a seamless, automatic process will reduce errors.

NGP. What is your recommendation for sponsors of cardiac safety studies?
TKZ. Sponsors should cooperate with companies and core labs offering innovative technology. This will save time, cost and most important increase the reliability of study results. Naturally, this will be providers with own in-house know-how and technology, not only relying on standard equipment offered by the well known big diagnostic equipment manufactures. Core labs with own technology will be able to customise their solutions to the specific needs of sponsors!

NGP. How should, on the other hand, core labs strategically react to the latest trends?
TKZ. Core labs not having own technology should look for strategic partnerships with innovative equipment and software companies ready to provide them with flexible and customised technology for their services. Only applying standard technologies will be a strategic disadvantage, not just in terms of cost but also accuracy and flexibility of offers.