The success of clinical trials is directly related to finding good quality volunteers and patients, which can be extremely challenging. Traditional methods of clinical trial recruitment, such as physician referral or paper-based methods have a very low success rate. One popular method of recruitment is advertising, used in a wide range of environments such as universities, hospitals, clinics, and in the media. During the recruitment process traditional methods can be helpful; however, they all require the subject to take the first step. Ultimately, many good quality volunteers simply never find out about clinical trial opportunities.

Text messaging technology is already widely used in consumer markets with immense success and is now developing into a workable solution for use in the pharmaceutical industry, particularly within clinical trials. With more than four billion mobile phone users estimated worldwide, this technology is a well-known means of communication. It can be successfully applied in the pharmaceutical and health care industries as a form of direct communication with clinical trial subjects.

This article will provide an in-depth look at a typical application of text messaging technology for patient recruitment at MDS Pharma Services.

MDS Pharma Services provides drug discovery and development solutions for the pharmaceutical industry. With more than 3000 employees globally, MDS Pharma Services applies advanced scientific and technological expertise from lead optimization, pre-IND research, early clinical research, and bioanalysis through to global clinical development, central lab, and centralized cardiac services.

MDS Pharma Services has study locations worldwide, including an early stage development clinic in Belfast, UK. The Belfast clinic carries out a wide range of studies, including Phase I studies testing new drugs in healthy human subjects. As a CRO, MDS has recruitment targets to meet, often on a short deadline, and must find and dose participants as quickly as possible. In 2006, its Belfast clinic began to experience challenges with its existing methods of subject recruitment and communication. As a result, the CRO looked to Exco InTouch to improve these areas through implementing mobile phone technology.

Challenge

Typically for Phase I studies, MDS Pharma Services requires an average of 30 dosed participants per study. However, to achieve this target, 300 potential participants are often initially contacted. Traditionally, it used a proprietary database to find potentially appropriate participants and then sent letters to each one and awaited a response. As the company's target population is largely composed of university students and other young people, MDS Pharma Services found that the potential participants' postal addresses often changed, making successful contact by mail difficult. In addition, it found awaiting a response from a potential participant to be a lengthy process, so it began to investigate alternative forms of participant recruitment and communication. MDS Pharma Services initially approached Exco InTouch for an alternative mobile phone-based solution based on the company's reputation for delivering effective patient communication solutions.

Text messaging technology

In clinical trials, text messaging technology can be utilized to recruit, locate, and screen potential patients. Response rates in clinical trials can range between 5% to 10% when traditional methods of patient recruitment, such as letters, are deployed. Text message technology can see rates of more than 30%. When compared with traditional methods, where results may not be seen for weeks or even months, text message-based recruitment results are immediate.

Cell phone technology can complement traditional advertising and patients can register for a trial by sending a text message to a short code, for example "Text TRIAL to 85342 to receive more details." Once the text is received, multiple workflows can be activated. These include a short text message-based questionnaire about the age, sex, and condition of the patient or a response can be sent that directs the patient to the nearest recruiting center to be screened for suitability.

The CRO initially approached Exco InTouch to manage a number of recruitment campaigns. These preliminary campaigns involved sending simple text messages to MDS Pharma Services' database of potential participants. Initial outreach was focused on a study requiring up to 1700 potential participants, and during this study, response rates increased by 32%.

MDS Pharma Services then implemented two strategies: First, the initial outreach was staggered to include up to 400 potential participants at one time, enabling the response system to manage responses from interested volunteers. Secondly, a two-way recruitment strategy was developed to allow participants to demonstrate interest via text message rather than telephoning the call center. This enables the CRO to analyze the profiles of interested participants and easily measure response rates against study targets and deadlines.

"The services provided by Exco InTouch are critical in ensuring that participant enrollment is on time and within budget. Using mobile phone-based technology for participant recruitment enables us to find suitable study participants more quickly than with any other method," said John Taylor, Head of Patient Recruitment at MDS Pharma Services.

In addition to the patient recruitment strategies, MDS Pharma Services has also implemented compliance-based technology from Exco InTouch, which enables the CRO to send timed medication and visit reminders, reducing lost-to-follow-up. If participants no longer want to take part in the study, they can easily text "NO" when receiving communication from MDS Pharma Services, reducing the time that it spends on soliciting responses and ultimately improving the quality of trial results.

Regulatory issues

The cell phone technology provided by Exco InTouch is fully compliant with both the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the EU Directive 2002/58/EC (Directive on privacy and electronic communication). This ensures that all data are encrypted to 256 bits, patient consent is obtained before communication begins, and that there is a simple opt-out service for patients or sites. Additionally, the solution has full message tracking capabilities and generates delivery reports to guarantee the surety of receiving the messages, providing a full audit trail in line with these regulations. Exco InTouch computer systems are also fully validated to comply with FDA 21 CFR part 11 guidelines.

Conclusion

Using outreach via mobile phone, MDS Pharma Services has seen typical response rates of 50% to 60% compared to approximately 5% when using paper-based methods. Through using the technology for subject recruitment, MDS Pharma Services can also address issues that arise during the trial. For example, during a recent study, it found that all suitable participants failed the blood test stage during screening. In order to keep to the deadline, the company needed to find 50 new suitable participants instantly, a feat not possible using paper-based methods or even email. However, by sending out a mass communication via text message, MDS Pharma Services was able to quickly find new participants in order to meet the study deadline.

Implementing cell phone communication strategies alongside existing procedures or as a standalone method ensure that CROs such as MDS Pharma Services can benefit from significantly improved overall data quality. This can lead to more successful clinical trials with improved recruitment rates and reduced lost-to-follow-up. Using text messaging technology in clinical trials offers a cost-effective, powerful, and nonintrusive method of direct-to-subject communication and overcomes the most common challenges in clinical trials. The technology is easy to use for both trial organizers and candidates and can help identify and locate potential candidates and encourage patients to proactively contact sponsors and CROs.

Tim Davis is Chief Executive Officer of Exco InTouch, email: info@excointouch.com
, and John Taylor is Associate Director, Patient Trial Services, for MDS Pharma Services.

MDS Pharma Services

http://www.mdsps.com/

Category: Contract Research Organization

Executive: John Taylor, Associate Director, Patient Trial Services, MDS Pharma Services

Headquarters: Belfast, UK Phase I Unit

EDC Goal: Increase Phase I subject recruitment

Previous Solution: Letters to potential subjects in proprietary database

John Taylor