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Ushering in the Age of the Digital Trial



By Allison Proffitt 
 
April 16, 2014 | The Pfizer REMOTE study—a clinical trial done completely virtually—is a bit famous in clinical trial circles. The study indication was over active bladder and every step of the trial process, from consent to data gathering was done virtually thanks to several tools provided by Mytrus. 
 
Clin BP winnerThe tools that enabled the all-virtual protocol were recognized in February as a Clinical Informatics News Best Practice at the fifth annual Summit of Clinical Ops Executives (SCOPE) held in Miami, Fla.  
 
The collaboration between Mytrus and Pfizer was a matter of perfect timing, said Anthony Costello, CEO at Mytrus. The company was just forming around the idea of virtual trials in 2009, and Craig Lipset at Pfizer was pushing for more patient-centricity in trials, including letting patients submit study data themselves. (Lipset spoke to Clinical Informatics News recently about patients’ roles in trials in The Rise of the Social Patient.) 

“We found Craig very quickly… because we had various mutual connections at Pfizer, and we started working pretty much right out of the gate with them on this first remote study,” Costello said. 
 
Running an all-virtual trial required a rethinking of many of the standard protocol steps. The patients in the trial never visited a study site. All of the patient’s interactions with study staff were done over the phone or via email. Study drug was shipped directly to patients at home. In some cases a home nurse would visit a patient’s home, and they did visit a local lab to get some labwork done. Those data were all sent into the Mytrus system for processing. 
 
“The IRBs and the FDA were all very supportive of this method from the beginning,” Costello said, never indicating any major concerns about a trial done this way. 
 
Of course, not all trials can be virtual. The model works best for large, simple trials, consisting of lots of people but small datasets, Costello said. But, he believes that to be 25%-30% of the clinical trial landscape. 
 
In order to structure the trial appropriately, Mytrus acted as a clinical site, Costello explained. “We had the doctors, nurses, physicians, [principle investigators], etc. on our staff through contracting relationships with [the University of California, San Francisco]. Pfizer worked directly with Mytrus as the clinical center, just like they would work with any other site on any other trial.” 
 
The licensing presented a small challenge. All of the investigator staff had to be licensed in all of the states in which the trial was recruiting. “In this case we had a doctor from UCSF that was virtually overseeing a patient from Texas or Kansas… That doctor, here at Mytrus in California, needed to go through the process of getting licensed in every state that we could potentially have a patient from.” The same held true for site coordinators and any other clinical research staff who would be dealing with patients or their data directly. 
 
The process wasn’t as bad as it sounds, Costello said, calling it a “fairly straightforward process” to get additional licenses, taking several weeks to a few months. 
 
Remote Access
 
Once the protocol was approved, Mytrus deployed two products to facilitate the process. 
 
Mytrus’ electronic informed consent product presents the consent process as a learning process with knowledge verification steps. The tool has been shown to do a significantly better job of “training” patients about the details of the clinical trial than simply presenting them with a paper informed consent document for review, Costello said. After patients walked through the eConsent process, they had a confirmatory conversation with the study physician over the phone. 
 
The other REMOTE trial tools fall under Mytrus’ Virtual Trial System, a system other sponsors can choose to implement piecemeal or as a whole. A pre-screening questionnaire linked from online study ads acted like a funnel, Costello said, with individuals advancing to the next step until they either failed to meet some study criteria or were enrolled. The online process made it very easy for individuals to start the process, Costello said, resulting in a very large “top of the funnel.” 5,157 patients in 11 states self-screened for the study. 
 
The study had a very complex inclusion/exclusion set up, Costello said, so the dropout rate was huge as would-be participants progressed through the process. “Depending on where they dropped out,” Costello said, “it’s possible to include those people in future clinical trials.” 
 
“As a company, one of our goals is to… find ways for those patients to find other studies that they do qualify for, or to at least be able to opt-in to be contacted for future studies.” 
 
Once patients had joined the trial and were consented, they were able to enter all case report form data digitally from home, and receive personal reports after the trial—both first steps for the industry. 
 
In order to enable patient data entered digitally and securely, Mytrus drew on existing technologies in patient reported outcomes and electronic data capture, but really focused on ease of use. “The primary goal was 100% accessibility and ease of use that would enhance patient’s interaction and engagement with the study while also helping them to complete forms at the source and at the time they were having a particular study experience,” the authors of the entry said. 
 
The patient’s database included data forms for screening, randomization, baseline data, safety data, medications and over 40 additional data forms for each patient to complete over a 6 month period. The administrative interface for sponsor and site staff enabled them to review data, track adverse events, send email reminders, and perform other study management tasks. 
 
On the back end of the trial, Mytrus and Pfizer also worked to enable direct-to-patient reports that patients would receive via email or regular mail at the end of the project. These data reports were also intended to be a useful tool for patients to inform their personal primary care physicians about their clinical trial experience for the purpose of ongoing continuity of care for the condition of OAB.  
 
Because all of the relevant clinical data for the study were captured and contained within the Mytrus patient and administrative database, report generation was straightforward. Again, the focus was simplifying the presentation of the report as much as possible for increased patient comprehension. 
 
The REMOTE trial was a success, Costello said, but tools that enabled it are only part of the equation. “Of course none of these tools could be used completely separate from the clinical site team and sponsor teams that design and manage the study,” the entry authors emphasized. The tools developed by Mytrus and Pfizer to enable remote participation by patients, though, might help solve, “the age-old recruitment and engagement issues that have plagued clinical trials for decades—namely the requirement for patients to physically live near a study center and to visit that center very frequently throughout the study for data collection purposes.” 
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