Mobile phones are only available in certain countries, so how can this work for my international program?

Although mobile phones are still a relatively new technology, the global spread has been extraordinary. One of the reasons for this is that the infrastructure is cheaper and easier to set up than traditional landlines. Even in emerging countries such as India it is forecast that over 500 million, or half the country’s population, will own a cell phone by 2010 compared to only 5% who will have a landline. For this reason, connectivity in central Europe, Africa and Asia Pacific is very well established and stable. We currently offer connectivity to over 220 countries using 750 validated mobile networks.

OK, I can see that you might have the reach around the globe, but how likely is it that they my typical patient will own a mobile phone?

In February 2009 a significant milestone was reached. Over 4 billion people now own a mobile phone, or to put it another way, 60% of the world’s population! To put this in context this is three times the number of active landlines and well over twice the number of people accessing the internet. Adoption of the technology is faster than any other form communication with over 40 million new users every month.

Does the age or socio-economic status have any effect?

Simply by the sheer number of people owning a mobile phone and from our own therapeutic experience we have determined that this is not an issue. Although the extremely old would not be the ideal demographic in some therapy areas, we have worked extensively with the 'baby boomer generation' and we have worked with many patients over the age of 80. We also have a great deal of experience working in developing countries and have not experienced any issues with patients not owning a personal cell phone.

Are there are any problems with languages?

Our system can handle all 'multibyte' or 'unicode' characters which make up languages such as Arabic, Chinese and Urdu. Further, the messages received in any local languages are optimized to be as succinct and engaging as possible for the recipient.

So I can see that mobile phones may well offer a global, multi-lingual communication network but how does that help me and my clinical trial?

As we all understand, although patients sign the informed consent to participate in a clinical trial and follow the instructions provided by their Doctor, life sometimes gets in the way! Our technology not only helps with retaining subjects throughout the program but proactively reminds them about when they are scheduled to next visit their Doctor. The system is customized to fit the design of the protocol and the needs of the demographic.

Are there any key factors which make certain studies more appropriate for this?

Although our therapeutic experience is very broad we have found common themes on the studies we have worked with. Most studies seem to last at least 18 months in duration and often have longer intervals between visits in the maintenance phase. Many also have extension or follow-up periods built in for certain patient groups. We also find that patients who need to medicate themselves at home or perform medical tests, as required in Diabetes studies, have a natural affinity for using our services.

...and any that don't?

Apart from the very elderly who might not be so suitable in certain therapy areas, there really isn’t any. The important question to ask is how important is it to retain the patients in your clinical study. If there are thousands of potential patients queuing up to enrol, then perhaps this service isn’t as relevant as for those studies where patients are hard to find and therefore important to retain and to keep compliant.

How do you get the mobile phone number of the patient?

This can be done in several ways but the most common is for a trained member of the site team to enrol the patients via one of our secured web interfaces. Once the patient's mobile phone number has been entered and stored securely in our encrypted database, text messages are sent according to a pre-defined algorithm which is personal to each patient.

So that seems to equate to more work for the site, how do they feel about this?

Site response is extremely positive. Compared with many electronic systems forced upon sites this actually helps them out. Although they need to enrol the patient, taking a minute or two, site personnel benefit from the system automatically managing the patient retention process. No longer do site staff need to sit on the telephone trying to ensure that the patient is still coming in for their 9am appointment as the system determines this via timely interaction with subject via their own cell phone. Additionally, the visit schedule is generated by the software according to the requirements of the protocol when the patient is enrolled. This is an additional feature which sites see as a significant benefit as it means that they don’t have to schedule and document the visit schedule for their subject.

What happens if the patient wants to stop getting these messages?

With the exception of eDiary reminders, this is handled by the site. If a patient wishes to discontinue this service they can contact the site who can remove them in a one click process. In our experience, this works more effectively than offering this functionality directly to the patient in order that the site can determine the concerns of the patient

How do your systems and software uphold regulatory requirements?

All Exco InTouch IT systems and processes have been architected to comply with HIPAA regulations. Additionally, any patient self-report data is digitally signed by the patient in accordance with FDA 21 CFR Part 11 regulatory requirements. Security is inherent within all applications with a full audit trail of all communication messages including date and time stamps which record delivery and receipt data.

What about local ethics boards? Do they have any concerns over this type of patient communication?

Throughout the 60+ countries in which we have conducted clinical trials to date we have not experienced any objections. We provide a summary document to the ethics boards describing what the system does, how the data is stored and how we uphold patient confidentiality and data security. In fact the only question we ever get asked is "If the subject does not have a mobile phone, will the sponsor be providing one?" The answer to that is down to the sponsor but as our experience has shown, there aren’t many people in the world today who do not already own a mobile phone.

Does Exco InTouch technology interface with any other clinical solutions?

Yes, Exco InTouch recruitment, retention, compliance and diary solutions are able to integrate with many in-house or third party applications to streamline the clinical process. For instance, compliance and retention alerts can be automatically scheduled following patient enrolment within an EDC system. Similarly, Exco InTouch text message reminders can be sent to patients to alert them to complete their diary self-assessments via their cell phone. These results can then be sent directly to the electronic CRF.