Seamless eClinical Solution from Perceptive

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In June 2011, Pfizer announced the REMOTE trial, the first "virtual" randomized clinical trial under an IND to assess the safety and efficacy of Pfizer's Detrol LA, a treatment for overactive bladder.

The study is specifically designed to test the methodology of the virtual trial concept, to determine if it can replicate the results of the previously completed Phase IV Detrol LA trial. The trial is called REMOTE for Research on Electronic Monitoring of OAB Treatment Experience.

In the past three issues of Applied Clinical Trials, we have written on the technology vendors involved in the trial—Mytrus, Exco InTouch, and Greenphire. Mytrus serves as the single coordinating center for patients, recruitment, the principal investigator, sub-investigator, and the coordinators; Exco InTouch provides the eDiary technology; and Greenphire is providing subject payments.

Technology applications

The remaining technology piece comes from Perceptive Informatics, which according to Bill Byrom, Senior Director, Product Strategy at Perceptive Informatics, is providing the core clinical trial technology applications of Randomization and Trial Supply Management (RTSM) and EDC via IVRS. Perceptive's role is to support the trial and is working closely with Pfizer to serve as the central integration point to join all third party technology applications to present a seamless eClinical solution.

In addition, Byrom told Applied Clinical Trials in an e-mail, "We are providing underlying foundational technologies to enable and power the patient and physician portal communities, as well as the integration and management of core eClinical solutions."

How the technology fits into the trial: 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 manage effectively 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," Byrom elaborated.

Data integration

An advanced integration framework has enabled Perceptive to be the hub for all data integration between the clinical applications used in the trial. The solution provided by Perceptive offers a means for these technologies to work seamlessly and provide the work flow and data flow essential to implement Pfizer's new model for studies.

According to Byrom, from a clinical trials standpoint, the REMOTE trial is a new paradigm in study execution that aims to eliminate the difficulties in patient recruitment by operating a study whereby patients from any location can enroll, independent of their proximity to a study site. The promise of this approach is to make clinical trials accessible to a much wider patient population and hence reduce the timeline required to enroll subjects.

Enrollment

This kind of enrollment relies upon an effective means of identifying patients that may be eligible to participate outside of individual study site pools. Direct-to-patient advertising for clinical trial participation may be a key methodology accompanying this approach, and may also enhance the attraction of utilizing commercial trial participant databases which, until now, have had variable success due to the requirement to select only a subset of potential patients representing those within a short distance of defined study sites.

He adds, "The study pushes the boundaries in the way trials are conducted—in particular the subject screening, consenting, medication dispensation, and safety management processes. It's a truly innovative concept that will have greater utility in future studies."

Innovation

Because the virtual trial approach represents a new level of automation and information exchange to meet the needs of patients, physicians, and clinical research teams, it provides a good example of Perceptive's commitment to technology innovation. "Our investment in our eClinical platform has enabled Perceptive to play the key role in providing the mechanism to integrate the combination of trial technologies in play to create a simple workflow for all key users: patients, investigator, and sponsor. The technology infrastructure and innovation Perceptive provides helps customers increase trial efficiency and improve data access," said Byrom.

—Lisa Henderson