A Breadth of Perspectives to be Represented in this Half-Day Workshop

MADISON, Wis. (June 20, 2009) — A power-packed roundtable discussion has been assembled to explore issues around patient accrual as part of a pre-conference workshop at the upcoming Onsemble 2009 Fall Conference. For the fifth consecutive conference, a workshop will be included that is specifically designed for clinical trials office leadership. As in the past, this workshop will also focus on developing measurements, or “metrics,” for the purposes of understanding and improving clinical research operations.

A breadth of perspectives will be represented by two special guests who have been invited to give presentations and participate in the patient accrual roundtable.

Bringing the pharmaceutical industry perspective, Daniel Davis, oncology clinical operations team leader at Lilly, will explore, “Industry Clinical Research Sponsor Perspectives.” In his presentation, he will discuss current pressures pharmaceutical companies are experiencing and how they are refining their research processes in order to get high-quality work done in a timely and cost efficient manner. His presentation will touch on such topics as: regulatory timelines, contracts and budgets, patient enrollment expectations, and data management. Davis brings 22 years experience, most of it spent in the oncology arena, in the pharmaceutical industry to the discussion.

Linda Parreco, RN, MS, from the Office of Partnerships and Dissemination Initiatives at the National Cancer Institute (NCI), will be addressing NCI initiatives to improve clinical trial accrual. Her group is working to identify ways to support recruitment through education, training, communication strategies, and tools. One of these initiatives is an online tool, in the early phase of development, that will support recruitment efforts for NCI clinical trials.

The first Onsemble workshop to focus on metrics was held in September, 2007. The decision to hold such a workshop emerged from the observations at member centers that it was difficult to quantify and communicate operational challenges related to protocol performance, protocol implementation, and research staffing. These workshops are now held at every Onsemble conference and a poster based on the work done in this group was presented at the ASCO meeting in May, 2009 by Kerry Bridges, MBA, RN,CCRC, of the Indiana University Simon Cancer Center and Henry Durivage, PharmD, of The Cancer Institute of New Jersey.

This spring, a collaborative initiative, headed by Bridges and Durivage was launched to build on these successes and provide a more formal framework to accomplish the work that is done in this area.

To date, significant progress has been made by the participating centers, particularly in three areas:

1. Observations regarding protocol performance. This has resulted in the establishment of methods to measure the impact of initiatives. For example, the effectiveness of protocol selection rules have been measured and proven to improve protocol performance.
2. Protocol implementation metrics. This has resulted in the establishment of protocol implementation benchmarks and score cards to allow centers to compare their performance against performance of all participating centers and to pinpoint areas for improvement.
3. Regulatory staff effort. This has resulted in the ability to estimate regulatory capacity with more precision than previously known. Data from 17 participating Cancer Centers resulted in actual (median) number of hours worked to open a protocol by sponsor type as well as regulatory staff capacity required per center.

Participation in the collaboration and workshops is open to all OnCore centers and other institutions. Centers interested in participating may contact Kerri Phillips at info@onsemble.net.

Onsemble conferences provide important networking and educational opportunities for people concerned with excellence in clinical research operations. Starting as a consortium of cancer centers that use the OnCore® platform to manage their clinical research operations, the Onsemble community now boasts 27 centers and a membership of almost 700.

At the upcoming workshop, some of the most recent outcomes of the collaboration will be presented in the form of aggregated measurements collected from participating cancer centers. The data will be reviewed and evaluated and the group will further explore any noteworthy results.

Onsemble® is a community of people who are committed to excellence in cancer clinical research operations. Onsemble members share best practices, contribute to an ever-growing knowledge base, and provide input into OnCore’s evolution. PercipEnz Technologies, Inc. hosts Onsemble resources as a service to the community.

Founded in 2000 and headquartered in Madison, Wisconsin, PercipEnz Technologies, Inc. develops enterprise-class clinical and translational research management software. The company’s flagship product, the OnCore® informatics system, is the nation’s most widely adopted clinical research platform among academic research organizations and cancer centers.

The OnCore platform is the result of nearly a decade of experience working closely with large research organizations, including many world-class NCI designated cancer centers and institutes funded by the National Institute of Health’s Clinical and Translational Science Award (CTSA) program. By actively engaging users throughout the development process, PercipEnz delivers solutions that address the underlying operational challenges facing organizations and their staff. The OnCore system is a proven, effective, and sustainable informatics infrastructure that supports streamlined clinical research operations. The platform is powerful and secure while providing the flexibility required by individual institutions to support their unique organizational structures and workflows.