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International Clinical Trials

Moving Data, Not Patients

Despite the vast benefits that can be accrued, the use of technology in healthcare is a relatively unexplored avenue in clinical trials. Erik J Fransen of Vitaphone Telemedicine delves into the uses of telemedicine in cardiology and asks if it really is the answer to today’s challenges

Clinical trials tend to grow in scale and last longer than originally planned, which results in the costs of developing new therapies escalating rapidly. In contrast, the overall success rates for the approval of new medicines is declining; only one in three marketed medicines ever recover their R&D costs. These trends put already limited resources in increasing demand that are not sustainable long-term. Therefore, to increase the chances of a company being able to recoup their investments made on a therapy – either medicine or medical device – it is of the utmost importance to accelerate promising therapies through the development process as quickly as possible.

THE BENEFITS OF TELECOMMUNICATION
Significant savings and efficiencies can be achieved by implementing an electronic interface between the sponsor, investigator and patient. Technological solutions help all parties involved in clinical trials to cope with the plethora of data, which helps to reduce therapy development times and increase productivity. These electronic interfaces provide support, either in the flow or capture of data, and are able to assist in the decisionmaking processes. Thus, the clinical trial life cycle can be reduced by collecting quality data quickly and by accelerating the availability of data. Despite the significant cost savings and efficiencies that can be achieved from scaling up the use of electronic aids (for example, transtelephonic monitoring (TTM) and electronic data capture (EDC)), a fairly substantial population of studies are still being run using paper as the primary medium.

However, it is recognised that the use of telecommunications technology to provide, enhance or expedite healthcare services, including clinical trials, could significantly boost the clinical trials process. The generally accepted term for the use of these technologies in healthcare is telemedicine.

The use of technologies in healthcare – or telemedicine – allows healthcare professionals to evaluate, diagnose and treat patients using telecommunications technology without the need to travel. ‘Move data not patients’ is the principal, and this is an attractive, yet relatively unexplored, option in the conduct of global clinical trials.

TELEMEDICINE IN CARDIOLOGY
As cardiovascular diseases have assumed an enormous role in terms of health economics, so has the focus in developing telemedicine solutions in recent years focused on these diseases in particular. Despite the remarkable medical progress made over the past few years, cardiovascular diseases are still the number one cause of death in developed countries. The advantages of telemedicine are apparent upon examination of its applications in the field of cardiology; such applications are now well-established and the associated benefits scientifically and economically documented. They safeguard the health of patients with a high risk of ischaemic events or heart rhythm disorders, and are also useful in the therapy-management field for chronic heart insufficiency patients.

It is important to judge the clinical situation immediately, as well as to take the necessary therapeutic measures and to control their efficiency over a long period of time. Consequently, telemedical projects include the establishment of non-stop monitoring of patients with increased or a high risk of cardiovascular incidents, starting with the hospitalisation, then postoperative/post inhouse healthcare, and up to home care. This kind of monitoring needs to be adjustable to the respective situation modularly in order to guarantee the smooth surveillance both in the stationary and the ambulant sector. In addition, it has to be individually adjustable to the demands of monitoring certain functions – such as heart rate, blood pressure, S-T segments, oxygen saturation, weight, breathing rate and temperature – as well as the intensity of the monitoring (that is, event recording and ‘on-demand’ versus continuous monitoring).

Undoubtedly, these techniques can also raise the standard of clinical trials. Digitalisation and electronic data transmission not only help to foster better, faster, more efficient and secure communication in clinical trials, but they also rationalise and amend the quality of new diagnostic-, therapy- and follow-up treatments. One of the major advantages of using telemedicine solutions in clinical trials is that it makes data highly accessible to all partners involved in clinical research, whether it directly improves patient care or more accurately allows the determination of the safety and efficacy of a new drug or procedure.

The field of cardiology offers pertinent examples of the implementation of telemedicine solutions – not only in daily clinical practice, but also in clinical trials – take for instance transtelephonic monitoring of electrocardiograms (ECGs). This technique has already been shown to be highly accurate and effective in several trials (1,2). On a daily or weekly basis, or in the event of any complaints, patients are obliged to actively transfer their ECG via trans-telephone to a tele-ECG receiver.



Electrocardiographic parameters are a critical component of many clinical trials as they are used for the evaluation of safety and to assess potential electrophysiologic vulnerability of patients receiving investigational cardiac or non-cardiac therapies. Moreover, cardiac safety issues, measurable by ECG, have presented the most common reasons for drug withdrawals from the market.



As a result, regulators around the world have introduced expanded requirements for the use of ECG in clinical trials to ensure patient safety. Regulators have also worked to define requirements for the digital submission of archived ECG data, increasing the importance of appropriate ECG data collection and management. An ECG core lab provides expert, objective, accurate and timely review of pre-specified, study-related ECG variables. This analysis can be used to identify ECG or safety endpoints, or clinical trial cases to be reviewed by a clinical events committee for clinical endpoint determination. In an attempt to improve and standardise the investigation of drugs with potential proarrhythmic properties prior to approval, the Food and Drug Administration (FDA) has set up an initiative advocating the collection and storage of digital ECG data. As a result, the capture of primarily digitised ECGs will become more common. The adoption of easy-to-use tele- ECG-cards, in combination with a worldwide free phone number, facilitates this and offers the sponsor the ability to collect large numbers of ECG data at relatively low costs and with little effort. Patient can record ECGs themselves and transfer them to the sponsor’s central server by phone in a matter of seconds. This provides a simple yet effective way of gathering a vast amount of cardiac data of study patients, for example, measurements of the QT interval over the course of drug exposure. These systems should not just be seen as an adjunct to drug development but should be central to the drug development process. Companies that use these smarter and more efficient technologies will get their drug to the market faster.

CONCLUSION

Leaders in clinical trials are increasingly accepting automated measurements, performed by subjects at home, as standard. It provides a simple and cost-effective means of obtaining a larger and consistent dataset, which is very valuable for research. As the measured data are immediately available to the investigator, they can respond directly when participants do not comply with the protocol. This continued feedback increases the compliance of participants in the trial, which will increase the amount of available valid measurements dramatically.

Telemedicine offers immense opportunities for global clinical trials as it facilitates fully paperless clinical trial monitoring options. Vital signs can be measured at the study patient’s home using medical devices which have been clinically validated and approved. Telemedicine solutions can help to reduce the workload for the industry, the clinical trial investigators, as well as the patients themselves. The question now is not whether the use of telemonitoring devices and services is of putative value or not, but rather, how long can you afford to operate without them?

References
  1. Fetsch T, Bauer P, Engberding R, Koch HP, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe HJ, Treese N and Breithardt G, Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial, European Heart Journal 25: pp1,385-1,394, 2004
  2. Patten M, Maas R, Karim A, Müller HW, Simonovsky R and Meinertz T, Event-recorder monitoring in the diagnosis of atrial fibrillation in symptomatic patients: subanalysis of the SOPAT Trial, Journal of Cardiovascular Electrophysiology 17: pp1,216-1,220, 2006


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Erik J Fransen studied Health Sciences at the Maastricht University, Netherlands. After his studies he joined the cardiac surgery department of the Maastricht University Medical Center (MUMC) as a research assistant where he later got his PhD in Medicine in 1999. After his PhD, Erik worked in managerial roles in clinical research, for both centre initiated projects as well as industry sponsored projects. Later he became head of the joint department of clinical research for both cardiology and cardiac surgery projects. In 2005 he left the MUMC and became Manager, Research and Technology, at pacemaker company Vitatron, before joining Vitaphone Telemedicine as Manager, Medical Programs. Email: erik.fransen@vitaphone.nl
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