Pfizer is the world’s largest research-based pharmaceutical company, operating in 180 countries worldwide. With more than 90,000 employees globally, Pfizer discovers, develops, manufactures and markets prescription medicines in 11 therapeutic areas.

Pfizer has a number of major research and development sites around the world dedicated to the discovery and development of new medicines. These sites carry out a broad range of studies including Phase I trials testing new drugs in healthy human volunteers. Pfizer depends on effective subject recruitment to conduct successful clinical trials. The company has recruitment targets to meet, often within limited timeframes, and must find and screen participants as quickly as possible.

Pfizer often experiences challenges with traditional methods of subject recruitment and communication, and as a result Pfizer selected Exco InTouch’s mobile phone technology as one method to streamline the company’s interaction with its research volunteers.

Pfizer has three Phase I sites in New Haven, Connecticut, Singapore and Brussels, Belgium. As with all Phase I studies, recruiting suitable participants for clinical studies at these sites was challenging and can have a direct effect on the success of the entire clinical program. Traditional letter and phone-based recruitment strategies can be time-consuming for the organisation and exhaust valuable resources, adding time and cost to each study. Even more modern approaches such as email were found to have a low take-up rate, particularly at the Brussels clinic which has recently started to recruit a higher number of elderly volunteers. Clinic staff found that elderly people do not often have access to a PC and are not set up on email, meaning that often letter and phone- based outreach were the only options available.

As traditional methods of subject recruitment were found to be less effective and costly, Pfizer began to investigate alternative methods of recruitment and communication. Pfizer’s recruitment targets vary per study but the pharmaceutical company typically requires 10 subjects per trial. However, sites often need to screen two or three times the required number of subjects in order to achieve a group of suitable volunteers.

Pfizer required a standardised subject recruitment strategy to be implemented across all its Phase I clinical trials that was effective, could accelerate the recruitment process and therefore speed up clinical trials. Pfizer approached Exco InTouch as a result of the company’s reputation for providing subject communication systems.

Pfizer uses Exco InTouch’s ATLAS text messaging technology to improve the efficacy of its patient recruitment and retention in Phase I clinical trials. The Exco InTouch solution was selected as a result of the company’s strong relationships with mobile carriers worldwide, as Pfizer aimed to standardise on one system across its three global Phase I sites.

ATLAS is a unique, regulatory compliant system used to send text messages to any mobile phone. ATLAS can be integrated with a wide range of existing healthcare management systems and is used in a wide range of Phase I clinics to create regulatory compliant messaging services for patient recruitment. The ATLAS technology is fully integrated with Pfizer’s own volunteer database. This allows immediate text message-based communication with selected patients and enables fast assessment of a potential subject’s suitability via text message within 5-10 minutes.

With Exco InTouch’s integrated text messaging system, Pfizer is able to promptly send alerts from a range of text message templates to the recipient via their own mobile phone (for example “Text YES to 54321 to participate.”) Patients’ responses are then sent directly to Pfizer’s system, allowing recruitment staff to make immediate decisions regarding a potential subject’s eligibility to participate in a study.

The Exco InTouch integrated system also offers benefits for patients already enrolled in studies, as the system enables investigators to send protocol-specific questions, events or reminders to patients using ATLAS. In addition, ATLAS provides Pfizer with a complete audit trail by tracking the delivery of text messages with receipts which are sent directly back into the system, which enables compliance with FDA 21 CFR part 11 audit trail requirements.

As Pfizer deals with patient information which must be kept confidential, it is essential that the system comply with strict data protection regulations in the US, Singapore and Belgium. Within ATLAS, phone numbers and messages are encrypted at the database level and the system complies with FDA and HIPAA regulations.

The process of installing the centralised system in Pfizer’s clinics in Singapore, Belgium and the US took just three months. The Exco InTouch system is easy to use and as it is completely integrated, no additional training of Pfizer’s staff was required. ATLAS is also hosted remotely by Exco InTouch, so there was no need for Pfizer to purchase additional hardware to host the application. Furthermore, this enables Exco InTouch to provide ongoing support and quickly respond to any system maintenance issues, as well as periodically updating the system to ensure that Pfizer achieves maximum benefit.

The implementation of Exco InTouch’s system had an immediate impact on Pfizer’s recruitment strategy. The integrated system enables Pfizer to quickly identify, contact and assess relevant patients and maintain patient communication throughout the life of its Phase I trials across Belgium, Singapore and the US. The integration of the system has reduced the time Pfizer spends on identifying and recruiting suitable subjects.

Even among more challenging patient populations such as the elderly volunteers in Belgium, Pfizer’s clinic staff have found that mobile phones are ubiquitous where PCs are not. The recruitment strategy has been particularly effective in Singapore as mobile phones are extremely popular in the country and text messaging is one of the most common forms of communication.

Pfizer’s clinic staff also report that volunteers are receptive to recruitment via text message. Clinics have also reported that they are receiving volunteer responses more quickly via text message than with traditional letter, email and phone-based strategies.

As an additional benefit, Exco InTouch’s integrated recruitment system also offers Pfizer a contingency plan for Phase I subject recruitment. ATLAS is capable of processing over 500 messages per second, meaning that Pfizer can re-recruit a new group of subjects for any study within one day of finding out that initial subjects are not suitable. Pfizer selects potential participants from its volunteer database, integrated with ATLAS, and instigates immediate contact via text message. Subjects’ responses are then sent directly back into Pfizer’s system, allowing recruitment staff to make immediate decisions regarding a subject’s eligibility to participate in a study. This would be more difficult using traditional methods of recruitment such as letters, phone calls or emails; therefore the recruitment system developed by Exco InTouch helps ensure that enrolment is kept on course and on budget.

"Prior to the implementation of the Exco InTouch system, Phase I subject recruitment using traditional methods was more challenging and costly" comments Jonathan Ventresca, Senior Manager, Clinical Trial Operations at Pfizer. "With the adoption of ATLAS technology, we can quickly recruit subjects and drive them into clinics for the screening process. Pfizer is at the vanguard of implementing new technologies to streamline the clinical trial process and to date we have found the Exco InTouch system to be effective in accelerating subject recruitment for Phase I trials."

Following the implementation of Exco InTouch’s technology for its recruitment strategy, Pfizer now also uses the recruitment system to drive subjects into the clinics for screening. Pfizer can now set up clinic appointments via text message, enabling the organisation to fast-track the screening process.

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