By Ann Neuer
January 20, 2009 | Pfizer recently selected the Exco InTouch text messaging technology to improve the subject recruitment and retention process for its Phase I clinical trials. Exco’s text messaging capability, ATLAS, is a recently launched regulatory-compliant technology that Pfizer can fully integrate with its own database of Phase I volunteers. The integration enables immediate text message-based communication, also known as short message service (SMS) communication, with selected patients, allowing recruitment staff to make a fast assessment of a potential subject’s availability and eligibility.
To start the process, Pfizer can use a range of text message templates to send messages to recipients who can then respond to Pfizer’s system. For example, a recipient could respond to “Text YES to 12345 to participate”. This is a vast improvement over traditional methods such as the mail, which is slow and yields a notoriously low response. “We can reach extremely busy people quickly, wherever they might be, at work, stuck in traffic, on the train, in college. It’s the immediacy that’s the real advantage,” says Exco’s CEO Tim Davis.
In addition to reaching potential volunteers for upcoming studies, Pfizer is mostly using the ATLAS text messaging capability to remind enrolled subjects of upcoming appointments. Adam Linkov, Volunteer Recruitment Manager for Pfizer’s Phase I Clinical Research Unit in New Haven, Connecticut says the largest measure of success will be the increased “show rate,” that is, fewer broken appointments. “We particularly like that the Exco system is automated for us. Once a volunteer says they want to participate in a study and agrees to receive text messages, the system takes over from there. Volunteers automatically get a text reminder of upcoming appointments and are asked to respond as to whether they will be able to keep the appointment,” Linkov explains. He adds that the cost per message is relatively affordable as compared to traditional methods such as television and radio, provided it’s effective.
Pfizer started testing its text message effort in early summer, and is focusing on Phase I for several reasons. The company’s Phase I units already have a database of people who have previously participated, and the company owns its Phase I units, which, in addition to New Haven, are also located in Brussels, Belgium, and Singapore. Vincent Monsonis, Manager of IT Systems at the New Haven unit explains that Pfizer uses an application called Phase I Management System (PIMS) to manage all aspects of Phase I trials for the locations, including interactions with volunteers and collecting data from volunteers. “The Exco text messaging application resides within the volunteer recruitment area of PIMS,” Monsonis explains.
The clinical trials sector is sorely in need of solutions such as these to address the subject recruitment and retention dilemma, one of the industry’s most intractable challenges. In this regard, Exco claims to be making dramatic inroads. The company states that through its SMS service, it is reducing follow-up rates by more than 20%, seeing better results in patient visit attendance, and improving recruitment responses by 500%. “We came up with this figure by knowing how many text messages are sent out and then measuring how many responses come in, either by text response or phone calls. When you send out paper mailers to a known database of volunteers, you typically expect about 5% of people who receive the letter to actually respond. Our current average response rate is 28%,” Davis says.
The ATLAS application is a database integration tool that allows clients to distribute text messages to all countries where volunteers live. Since its recent launch, ATLAS technology has been used in more than 20 clinical trials. Currently, messages can be sent to 220 countries across 650 cellular networks.