Texting offers instant contact and feedback.
By Tim Davis
May 19, 2009 | Cell phone technology is a ubiquitous means of personal and professional communication and is now developing into a workable solution for the clinical trials arena. With more than 4 billion cell phone users worldwide, the technology is helping the pharmaceutical and health care sectors maintain direct communication with their clinical trial subjects.
Many large pharma companies are implementing cell phone technology as part of the clinical trial communications process—from subject recruitment through to collecting trial data. Text message alerts are a quick and effective way of communicating—with all cell phones having built-in text messaging capability. Using cell phone technology, companies can increase recruitment and retention rates by interacting directly with trial subjects.
Here, I examine the current strategies of subject recruitment, retention, and compliance during clinical trials; how problems can be overcome with the use of cell phone technology; and what the future holds for the technology within the pharmaceutical industry.
Bridging the Communication Gap
Effective recruitment is essential to a successful clinical trial. Conventional forms of recruitment including physician referral have a very low success rate. Advertising in the media, universities, hospitals, and clinics is a popular recruiting method, while some organizations prefer to write letters to potential participants inviting them to take part in studies. Traditional methods can be useful during the recruitment process; however they require the subject to take the first step.
Working with communication providers, sponsors can interact directly with subjects in a personalized and cost-effective way. Cell phone technology integrated into the clinical trial communication process at an early stage opens up direct communication channels. Existing advertising campaigns can be enhanced by printing a short code on advertisements, encouraging subjects to text details relating to a specific trial. Potential participants can then be directed to call centers or self-enroll using their cell phone. Recruitment results are delivered instantaneously compared with traditional methods where results might not be seen for weeks or months. Cell phone technology can offer recruitment response rates of over 30% compared with typically 10% for more traditional methods.
Non-compliance costs the pharmaceutical industry billions of dollars each year. Significant costs can be incurred by sending out reminder letters or making telephone calls to subjects to ensure they comply with the requirements of the study. This is another area that can be tackled using cell phone technology to distribute automatic reminders directly to the subject. Messages can be tailored to the individual to include information such as dosage, frequency, and how to take the medication safely. Delivery reports or interactive messages can be employed to ensure that messages are received.
Ongoing support and motivation is often needed to support participants throughout a clinical trial. Sponsors use various methods to keep subjects involved in a study including providing detailed paper-based information on the medication and side effects at the outset of a study. In order to keep participants well-informed of the aims of the trial and to remind them of the benefits of remaining in the study, short messages can be sent to motivate and enhance confidence in the trial.
Cell phone technology offers a powerful method of direct communication and can be used to overcome the most common challenges in clinical studies. Subject reporting via text message can help to improve data quality and effectively determine the efficacy of a new drug. Cell phone communication strategies implemented alongside existing procedures or as a standalone method, benefit from significantly improved overall data quality and optimised use of resources.
Of course, security and confidentiality are important considerations and all methods of data collection and evaluations must be developed in accordance with strict regulatory requirements—FDA 21 CFR 11 and HIPAA in the U.S. and EU Directive 2002/58/EC in Europe. Subject consent should be obtained and an opt-out option should always be made available. All information must be encrypted and stored on a secure database in order to ensure full compliance with the EU data privacy act.
Analysts predict that text messaging technology will be superseded by new methods of cell phone communication, such as 3G, which enables more detailed and personalized data to be collected. As new cell phone technologies emerge, they will be developed and adapted for use in the pharmaceutical industry. Vendors in the sector will increasingly need to invest R&D activities in mobile technology to provide the most effective and compliant solutions.
Tim Davis is co-founder and CEO of Exco InTouch. He can be reached at tim.davis@excointouch.com.
This article also appeared in the May-June 2009 issue of Bio-IT World Magazine.
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