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Calls to speed up the clinical trials process usually involve a discussion about the decentralized IRB process, slow study start-up, and subject recruitment. Rarely does the dialogue drift to a wholly innovative and completely different way to conduct a trial. Yet, in June 2011, this is exactly what happened when Pfizer announced the REMOTE trial.
REMOTE is the first-ever randomized clinical trial under an investigational new drug (IND) application in which the study is managed entirely using electronic tools and allows patients to participate in the clinical trial regardless of their proximity to clinical sites. The pilot project uses mobile phone and Web-based technology to collect necessary data for the trial, without clinic visits.
The trial includes some 600 patients from as many as 10 states who manage their own trial activity, and report results directly to a trial investigator who in turn keeps close oversight. The expectation is time saved and the gathering better quality, more reliable data through increased patient compliance, lower withdrawal rates, and real-time data collection.
Pfizer and its research partners hope to determine whether the results of the pilot REMOTE “virtual trial” can replicate the results of a previously completed Phase IV Detrol LA trial, and in this way begin to validate virtual, patient-centered approaches to clinical research. Detrol LA (tolerodine tartrate) is a treatment for overactive bladder (OAB).
Pfizer reviewed the study approach with the FDA, and two institutional review boards have approved the study. Physicians will carefully monitor patient data and patient safety throughout the trial. Patients will be able to interact with study physicians remotely 24 hours a day.
Vendors providing technological expertise to this innovative trial are Mytrus, Exco InTouch,Greenphire, and Perceptive Informatics. Mytrus serves as the single coordinating center for patients, recruitment, the principal investigator, sub-investigator, and the coordinators; Exco InTouch is providing the eDiary; Greenphire is providing subject payments; and Perceptive Informatics is providing IVRS.
While all the technologies were accepted and integrated, the other remaining challenge was regulatory. While the FDA has been moving forward in other areas to increase patient involvement (e.g., formal guidance on Patient Reported Outcomes uses in labeling), when Pfizer brought the idea to the FDA, it was still uncharted territory. Craig Lipset, Head of Clinical Innovation at Pfizer, said, “In our first meeting with the FDA, the room was packed—both with FDA and Pfizer bringing legions of people in. But it wasn’t really to debate—it was to collaborate and find solutions, and it was a great experience in demonstrating the FDA’s willingness to support innovation.”
Pfizer was required by the FDA to acquire a waiver in order to be able to ship drugs directly to patients’ homes, something that Lipset predicts FDA will have to address in further policies and standards (to avoid having to issue such a waiver every time), if virtual trials become popular.
Could remote trials result in speedier, more accurate data? Lipset believes this is so based on the self-reporting aspect, meaning results will be reported as they happen (such as by checking in to a bladder diary throughout the day), rather than waiting six weeks or more to report results back to a typical trial investigator on-site. “Think about the barriers in place for existing large-scale trials. With multiple sites to select and activate, we have to find patients and recruit them in proximity to those sites. This model has simplified many of those time-intensive tests,” explains Lipset. “I think one of the interesting differences for this project is that patients are connected to the trial 24/7, and it gives us the opportunity to respond in real time if there are safety issues. We feel that this level of continuous, real-time engagement actually exceeds the current standards and baseline for safety monitoring in conventional trials.”
We checked in with Lipset last week to discuss REMOTE’s progress. He said, “There is different data that we will come out with over the course of the year sharing the status of the REMOTE trial in different settings. What I’ll say right now is that we’ve had great support from our technology partners. We’ve had great support from regulators and ethics committees. We’ve had some challenges in terms of getting significant numbers of patients into the study. And that’s okay because, in large part, if everything worked perfectly, then either we were geniuses or we didn’t push the boundaries hard enough.”
And while Lipset does believe they are smart, and they are pushing the boundaries, they also view this as a learning project. Currently, they are capturing data and reacting and making modifications to the trial in real time.
In the meantime, as the project moves forward, Lipset elaborated on future patient-centric clinical trials. “At Pfizer we have viewed this project as delivering both parts, modules, as well as a very clever, complete package. So what I mean by that is there are a number of discreet modules that we are testing and demonstrating in the conduct of this pilot — our ability to recruit patients online, our ability to screen and consent patients online, our ability to enable patients to have visits take place at home or to ship study drug directly to the patients in their home.”
So moving forward in future Pfizer trials, Lipset foresees instances that they can put the pieces or modules together in other ways. “Perhaps it’s in areas as diverse as rare diseases, the idea of bringing the trial to the patient, wherever they may be. Or it could be another primary care indication as we’re piloting now. But, for us, it’s also a win to have a portfolio of modules that we can reuse in more conventional brick and mortar studies to make it more accessible for patients.”