It’s good to text

Tim Davis looks at the growth of SMS technology as a communication strategy in patient recruitment and retention, and examines the patient security and regulatory issues involved

More than half the world’s population now owns a mobile phone and many users favour communication via short message service (SMS) over the more traditional phone call. In fact, eight out of 10 under-25s prefer to communicate via text. Not surprisingly, text messaging has become an efficient method of communicating directly with clinical trial subjects, with pharmaceutical sponsors increasingly using SMS technology for patient recruitment and retention, and electronic patient reported outcomes (ePRO) developments to improve patient data capture.

Traditional strategies

The limitations of traditional subject communication methods in clinical trials means mobile phone technology can be an attractive alternative. Patient recruitment by physician referral – which can have success rates as low as 14% – is now increasingly accompanied by recruitment through advertising in the media and in environments such as universities, hospitals and clinics. A strong call to action in an advertisement, such as a phone number or website address where potential candidates can access further information, can help recruitment, but these methods while useful, still require the patient to take the first step.

Patient non-compliance is of course one of the most significant challenges for clinical trials organisers. Non-compliance rates can be as high as 80% – costing industry US$75 billion per year – and a significant proportion of this cost can be attributed to developing targeted reminders for patients, including letters and telephone calls, to ensure subjects comply with the requirements of the study. Again, however, these methods require little or no interaction on the part of the patient.

A patient may decide to leave a study for a number of reasons – they may experience unusual symptoms or feel a lack of support from study organisers. Sponsors currently utilise a range of methods to keep patients in a study, including providing detailed paper-based information on the medication and side-effects at the outset of the trial, but this information can often be lengthy and difficult to understand, and patients usually require ongoing support and motivation throughout the life of a clinical trial.

Talking text

By using mobile phone technology to interact directly with patients in the initial stages of recruitment, pharmaceutical sponsors can support existing recruitment advertising in a way that is confidential and personal to the patient. For example, patients can text a specified shortcode from a recruitment advertisement to register their interest in participating in a trial. They can then be directed to patient recruitment centres or prompted to self-enrol, usually by means of a short questionnaire sent by SMS to the patient’s mobile.

Unsuitable candidates can therefore be identified at the outset. Moreover, the technology allows recruitment results to be delivered instantaneously. To-date, SMS technology is typically providing recruitment response rates of more than 30% compared with around 10% for traditional methods.

SMS technology can also help improve compliance by allowing automatic reminders to be sent directly to the patient’s mobile phone, prompting them to take their medication or to attend clinic appointments. These messages – which can be one- or two-way – can be tailored to the individual patient to include information such as dosage, frequency and – importantly for patients taking multiple medications or those with complex medication schedules – how to take the medication safely.

Motivational support is key to retaining patients on a trial, and SMS messages and alerts can be used to keep patients informed of the aims of the trial and to remind them of the benefits of remaining in the study. Motivation can be renewed through short inspirational messages that appear to have been sent by the patient’s physician – again enhancing patient confidence in the trial. This type of action can help improve lost to follow up rates by up to 20%.

Patient reporting

Alongside SMS technology, recent developments in ePRO technology mean that accurate patient data can be collected quickly and efficiently during a clinical trial. Sponsors now have access to eDiaries to retrieve information directly from subjects, while patients can complete diary questionnaires via a series of text messages. Secure text messages with unique PIN codes enable patients to easily record and transmit data back to the clinical trial organiser using their own mobile phone.

Studies have shown that eDiaries can increase patient compliance rates, reduce overall clinical development costs, improve the quality of patient reported data and minimise the time and effort required for study set-up. Moreover for the sponsor, accurate patient data is essential in determining the efficacy of new medication

Regulatory challenges

It is essential that SMS communication strategies are developed in accordance with the regulatory requirements of FDA 21 CFR 11 as well as the US Healthcare Insurance Portability and Accountability Act of 1996 (HIPAA) and the EU Directive 2002/58/EC (Directive on privacy and electronic communication). Consent should be obtained through the initial SMS outreach and an opt-out option should always be made available. All information should be encrypted at 256 bits and stored on a secure database, with full message tracking capabilities in order to ensure full compliance with the EU data privacy act. By allowing full message tracking and the generation of delivery reports, the technology not only offers assurance that the messages have been received, but also provides a full audit trail in line with the regulations.

With the onset of 3G technology, patient recruitment in future may well involve cell-phone based email and instant messaging, with the further option of using photographs and animated messages. For the moment, however, SMS technology, both in the developed and developing world, remains an important and novel approach to improving recruitment and retention rates.

Tim Davis is co-founder of Exco InTouch, a leading provider of global, secure and regulatory-compliant short messaging service (SMS) solutions to the biopharmaceutical and healthcare industries (www.excointouch.com, email: info@excointouch.com)

Original artical can be found here: http://www.clinicaldiscovery.com/readArticle.aspx?articleId=112