Web-based Technology to Help Manage Independent Review Panels

Clinical trials are relying upon independent event and data review committees with increasing frequency. Clinical Endpoint Committees and Clinical Event Committees play important roles in monitoring patient safety. However, the timely collection of data from such committees is frequently challenged by the logistics of having committee members gather in a central location. This challenge is heightened by the use of thought-leaders on committees, whose busy schedules may prove limiting to the review process. Distributing copies of information to decentralized reviewers is possible for some programs but may be limited where data is difficult to copy or the quality of such copies may be inadequate, such as with medical images. A lengthy panel process limits the ability for Sponsors to make timely decisions based upon review committee findings.

The Perceptive Solution

The Perceptive Virtual Panel System (VPS) is a web-based application that combines the functionality of a document repository with electronic data capture. The VPS electronically distributes clinical endpoint data to virtual panel members for review, and then collects their assessments using electronic data capture forms. The application incorporates sophisticated workflow management and query management tools to make the process highly efficient. The system is developed, validated, hosted and managed by Perceptive.
When an event or endpoint occurs, clinical data is collected and scanned, or uploaded, to a document repository to create an electronic dossier for the subject. Once a dossier is complete, it is placed in a work queue for one or more of the virtual panel members. Each reviewer accesses the secure web site, reviews the case, and completes the data capture form online. Built in edit checks help to ensure that clean data is collected at the time of entry. System logic can check for concordance between reviewers and schedule tiebreaker or other re-reviews of an event if necessary.

The system was designed with flexibility in mind. The VPS can accommodate any number of users and reviewers. System users are defined with specific privileges based on their role. So the various tasks of collecting clinical data and creating patient dossiers can be performed by users that can be located at different organizations such as a trial Sponsor, CRO or an independent review facility, depending on the needs of the specific trial.

Features

• Web based distribution of clinical data to virtual panel members
• Workflow management tool for streamlining the review process
• Sophisticated query generation and management tool
• Electronic data capture of the panel member findings
• Adjudication logic to trigger a tiebreaker review
• VPS reports for Sponsor
• Support for virtually any type of clinical data, including medical images
• Regulatory compliant (21 CFR part 11), validated and secure system

Benefits

• Alleviates the need for panel members to meet in person, thus saving the time, cost and logistical challenge of getting everybody together
  Permits international review panels to be more easily employed for your clinical trial
• Eliminates costs for shipping paper CRFs to panel members
  Reduces the cycle time for the review panel to perform its assessments
• Provides cleaner data through the use of EDC and online edit checks
  Performs concordance checks and triggers tiebreaker reviews automatically
• Gives sponsors immediate access to review findings through VPS reports

The diagram above illustrates just how the application operates in either a hosted or licensed environment.

Therapeutic Applications
Cardiovascular disease
Oncology
CNS disorders
Anti-Infectives (HIV)

Types of Independent Review Panels
Clinical Endpoint Committees
Clinical Event Committees