Srini welcomes attendees to the 9th face-to-face gathering of the Onsemble community.

Presenter:

Srini Kalluri, PercipEnz

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Setting the stage for the morning’s session, background will be given on what has been accomplished so far by the community along with some of the next steps that will be needed to continue progress in the area of measuring and improving clinical research operations.

Presenter:

Kerry Bridges, MBA, BSN, CCRC, Administrator, Clinical Research Office, Indiana University Simon Cancer Center

Aggregate data acquired over a two-year period from 14 cancer centers related to accrual to industry & cooperative group trials will be reviewed. An attempt will be made to answer the question, “Do rules make a difference?”

Presenter:

Henry Durivage, PharmD, Associate Director, Yale Center for Clinical Investigation, Yale University School of Medicine

Protocol performance and resource review analysis conducted by the Onsemble metrics group revealed significant issues regarding completion of investigator initiated clinical trials. Resource allocation and subject enrollment to clinical trials that were closed due to inadequate accrual were particularly problematic. Two centers will describe methods that limit the number of patients enrolled to under- performing clinical trials.

Presenters:

• Henry Durivage, PharmD, Associate Director, Yale Center for Clinical Investigation, Yale University School of Medicine
• Charleen Pagel Jue, RN, BS, Associate Program Director, UMN Masonic Cancer Center
• Ellen Graves Wojcik, MBA, CCRP, Winship Cancer Institute at Emory University

An update on the work being done by this group will be provided along with a demonstration of some of the new functionality available in the system. Preliminary analysis of data collected to date related to time and effort spent on protocols prior to enrolling the first subject.

Presenter:

• Martha Wellons, Assistant Director for Clinical Research, VCU Massey Cancer Center
• Erin Pennington, Clinical Trials Technical Director, Nevada Cancer Institute
• Beau Grignon, Senior Software Engineer, PercipEnz Technologies, Inc.

Central IRBs are designed to help reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. This presentation will examine the pros and cons of utilizing central IRBs along with one site’s journey in moving from using a local IRB to a central IRB review process.

Presenter:

Marie Jackson, PhD, MBA, Project Director, City of Hope

What happens after we a have identified all the operational inefficiencies in the process? Methods to help cancer centers achieve a balance of strategic imperatives in an era of declining resources and the need for industry bench-marks.

Presenter:

David Dilts, PhD, MBA, Director of Clinical Research, OHSU Knight Cancer Institute

This presentation will explore trends, management techniques, and lessons learned through collaborations with the pharmaceutical industry. Top tips and successful strategies that have been employed at the Mayo Clinic Cancer Center to facilitate these collaborations will be shared.

Presenter:

Aimee Tillman, MBA, Program Manager-Research Operations, Mayo Clinic Cancer Center

Motivations behind the selection of OnCore such as a desire to reduce the hurdles for clinical research will be discussed as well as the experiences of the institute in implementing the new system. The “Top 10” key elements to a successful implementation will be proposed.

Presenter:

Marc Drezner, MD, Director, University of Wisconsin Institute for Clinical and Translational Research

Presenter:

Henry Durivage, PharmD, Associate Director, Yale Center for Clinical Investigation, Yale University School of Medicine

Why a single informatics platform to unify all clinical research across an organization is beneficial and the strategy behind designing such a system.

Presenter:

Srini Kalluri, President & CEO, PercipEnz Technologies, Inc.