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Companies such as ExcoInTouch, Pfizer, and others are turning to mobile technology.
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. In the Pfizer Phase IV study of Detrol LA for overactive bladder (OAB), this was the case, as most women with OAB are usually in their 60s. The eDiary device that was chosen was a Nokia cell phone, which were all pre-programmed and loaded with the eDiary application for each study subject's use. Additional costs of using a smart phone and the limits to the smart phone technology that could be unfamiliar to this therapeutic population were eliminated by using an ordinary cell phone.
Exco InTouch specializes in interactive mobile solutions for many areas of clinical trials including recruitment, retention and compliance, postmarketing trials, and ePRO. Pfizer chose Exco InTouch based on previous experience using its technology in another trial. Its validated ePRO solutions include SMS or text technology; diary collection by mobile Internet cell phones; and application technology for smart phones, PDAs, tablets, and PCs. In the REMOTE trial, Pfizer used the cell phone with proprietary technology, programmed for local languages, timed messaging, and text reminders for subjects to record medications, volume of urine, and other protocol specific questions. The data are then transmitted real time to Mytrus servers, the virtual coordinating center for the trial (see Applied Clinical Trials, August 2011).
Virtual is one of the key words for the REMOTE trial—other terms to describe it are clinical-trial-in-a-box, patient-facing, or patient-centered. What it means is that Exco, along with Mytrus, Greenphire, and Perceptive Informatics, are providing solutions in this new clinical trial model that Pfizer is evaluating for methodology only. Mytrus serves as the single coordinating center for patients, recruitment, the principal investigator, sub-investigator, and the coordinators; Perceptive Informatics is providing IVRS; Exco InTouch is providing the eDiary; and Greenphire is providing pre-paid debit cards for subject payments.
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 as well as to reduce the number of calls made to the call center that Mytrus was running.
Exco used a pre-formatted, 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 Final Guidance for PRO (December 2009).
Davis feels comfortable with the level of technology, support, validation of the ePRO questionnaire, and phone use. The company has conducted trials in this patient population, as well as trials in urology, and is very glad to be a part of the first trial of this kind. "We are obviously supportive of it [the trial]," said Davis. "In the current environment, we don't expect the ability to do all clinical trials this way. But with this kind of therapeutic area, it is a great way to do it." Davis believes for this therapeutic area, it is underserved and very hard to recruit patients because of the nature of the condition and the challenges associated with unobtrusively fitting in the collection of how to fit the patient information recording into their day-to-day life. "If we have done that, then that is a positive," said Davis. "For certain therapeutic areas, this is the way forward. It is the way the world is going."
Davis acknowledges that virtual trials circumvent the site engagement activity, but this is necessary as a part of driving down the cost of trials. "People are looking at that incredibly seriously," noted Davis.
Editor's Note: Next month, Applied Clinical Trials will profile Greenphire's technology use in the REMOTE trials.