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When choosing a technology for a patient-facing clinical trial, the selection of the most appropriate data collection tool for the population using the study drug is a major factor. And in a trial of OAB, subjects are primarily women in their 60s. To self-report information, the eDiary device that was chosen was a Nokia cell phone. The phones were all preprogrammed for local languages, timed messaging, and text reminders for subjects to record medications, volume of urine, and other protocol-specific data. The data is then transmitted in real time to Mytrus.
Pfizer chose Exco InTouch based on its previous experience of using its technology in another trial. In designing their part of the virtual program, Exco CEO Tim Davis said, “We had to think creatively. There would be no direct interaction with the patient, meaning the site nurse wouldn’t be there to train the patient on the device since the trial isn’t site-based. We created an interactive training module on a DVD that came with the phone.” Davis also said that they engineered the product and process so the patient could do as much as possible out of the box and to reduce the number of calls made to the call center that Mytrus was running.
Exco used a preformatted, publicly available paper-based questionnaire that it adapted internally for ePRO use and translated to the mobile phone. Pfizer then validated the questionnaire and device in accordance with FDA’s Final Guidance for PRO.
Keeping patients happy
Ease of use for a cell phone is good for patients in a trial, but effective and efficient payment is another way to keep subjects happy. Eighty-five to 90% of clinical trials have a stipend or travel reimbursement to compensate subjects for their participation. While reimbursement amounts may not be large from the perspective of industry professionals, the payments can still make a difference to a volunteer. Greenphire CEO Sam Whitaker said, “Many studies typically deliver reimbursements on a monthly or even quarterly basis. And it may only be $50, but even four to six weeks can be a long time for a patient to wait to receive his payment, especially when a real cost is incurred to participate, and for these patients, $50 is important.”
Thus the heart of Greenphire’s ClinCard System, designed to execute clinical subject payment and subject messaging, is to improve the patient’s—and the site’s—study experience. Its ability to implement an automatic, electronic, patient-facing tool for a clinical trial is why Greenphire was chosen to deliver subject payments for the REMOTE trial. While Greenphire’s ClinCard system includes text messaging and reminders, for the REMOTE trial, the ClinCard’s functionality is limited to delivering subject payments. Greenphire works directly with Mytrus, and the ClinCard that is distributed to the participants based on subject IDs is Mytrus-branded and funded.
The remaining technology piece comes from Perceptive Informatics. According to Bill Byrom, Senior Director, Product Strategy at Perceptive Informatics, the company is providing core clinical trial technology applications, RTSM and EDC, to support the trial, and is working closely with Pfizer to serve as the central integration point for joining all third-party technology applications to present a seamless eClinical solution.
The RTSM system controls the assignment of medication to patients and tracks direct-to-patient dispatch and receipt through integration with the patient−Web interface delivered by Mytrus. This enables the single central investigator to effectively manage the direct-to-patient medication shipment and dispensing process.
“We have integrated all third-party data—central laboratory, ePRO (Exco InTouch), Mytrus for patient self-reported data, and telephone consultations data—to enable our underlying EDC application to consolidate and report the full clinical data for each patient enrolled, providing remote monitoring and central management of all the data from the trial,” said Byrom.