Compliance, Consortia Among Hot Topics at Research Operations Conference

The Onsemble 2013 Spring Conference – held February 27-March 1 in Nasvhille – was host to more than 200 clinical research professionals from around the country. Co-hosted by the Vanderbilt-Ingram Cancer Center, the conference featured discussion on critical topics, such as disclosure requirements for ClinicalTrials.gov, billing compliance, conducting multi-site trials, and much more.

Compliance Matters

Regulatory oversight is an important issue facing the clinical research industry, as requirements continue to increase in scope and complexity. Sessions at the Onsemble 2013 Spring Conference addressed the latest related to disclosure requirements for ClinicalTrials.gov and billing compliance.

Barbara Godlew, President and Principal Analyst at The FAIRE Company, LLC, led a panel session and shared her expertise on the ClinicalTrials.gov registration and reporting requirements. She discussed the major challenges facing academic medical centers and cancer centers in the registration and reporting of clinical trial data to the government database. The panel also featured discussion on tools available to simplify the process, such as Forte’s OnCore^® eClinical solution, Virtify’s Clinical Trials Registration and Results program, and Deloitte’s PharmaCM solution. The panel discussion also featured the institutional perspective. A representative from Indiana University discussed the operational environment and challenges involved with the requirements.

A separate session focused on billing compliance, which continues to present significant challenges for clinical research institutions. Ryan Meade, JD, Partner at Meade, Roach & Annulis, LLP, led a discussion on the complex challenges institutions face in research billing compliance. Meade addressed common operational concerns. These included how institutions can find guidance for making determinations, and how they can identify qualified individuals within their organization to create a coverage analysis process.

Consortia in Trials

Consortia in clinical trials is an increasingly popular topic within the clinical research community as a growing number of institutions are participating in multi-site trials. Deb Kruser, Director of the Wisconsin Network for Health Research (WiNHR) shared the challenges and lessons learned in conducting trials through WiNHR, which began in 2005 and consists of four collaborating organizations: the UW School of Medicine and Public Health, Aurora Healthcare, Gundersen Lutheran Medical Foundation, and Marshfield Clinic Research Foundation. She will also share her experiences with the recently launched Midwest Area Research Consortium for Health (MARCH). Learn more about WiNHR.

The session then led into a roundtable discussion among leadership from Cancer Centers and Clinical and Translational Science Award recipients (CTSAs) about their multi-site trial operations. Representatives from Shriners Hospitals for Children, Levine Cancer Institute at Carolinas HealthCare System, and Vanderbilt-Ingram Cancer Center all shared their current operations and discussed the challenges and best practices in such areas as training, biospecimen management, and IRB management.

Additional Topics

A variety of presentations throughout the conference tackled additional important operational topics. Tesheia Johnson, Chief Operating Officer at the Yale Center for Clinical Investigation and Associate Director for Clinical Research at the Yale School of Medicine, discussed the institution’s recent project of integrating an eClinical solution with an electronic medical record system. The presentation provided an overview of the institution’s goals at the outset, its timeline for completion and future initiatives.

The conference also featured a special presentation from Dr. Mia Levy, the Director of Cancer Clinical Informatics for the Vanderbilt-Ingram Cancer Center and an Assistant Professor of Biomedical Informatics and Medicine. Dr. Levy discussed the personalized cancer medicine initiative at Vanderbilt, including an overview of the My Cancer Genome project, which is designed to guide actionable decisions regarding treatment options based on tumor genetics.

About the Onsemble Conferences:

The semi-annual Onsemble conferences are gatherings of the Onsemble community, which is largely comprised of OnCore users, and are facilitated by Forte Research Systems, Inc. With the vision of “for the members, by the members,” the majority of content is generated and presented by the members of the community. The community is comprised of cancer centers, children’s hospitals, research consortia, and AHCs. The people who attend are largely Clinical Trials Office leadership, clinical research associates, data managers, and regulatory managers, with some representation from other areas including clinical trials financials, clinical informatics, and biostatistics. Attendance is open to all clinical research professionals.