CLINICAL INVESTIGATIONS CORE

University Of Colorado Denver, Aurora CO

Investigators

Linked publications, trials & patents

Abstract

The Clinical Investigations Core Shared Resource (CICSRSR) supports the develop portion of the broader UCCC mission to discover, develop and deliver breakthroughs in diagnosis, treatment, and prevention that improve cancer care. Services and Personnel: This CICSRSR objective is accomplished by providing the necessary infrastructure quality and quantity to deliver exceptional cancer clinical trials research support across the UCCC consortium including: 1) Support of all aspects of clinical investigations including patient recruitment and treatment, collection of data, procurement of specimens, reporting of adverse events and coordination of care with other clinical services; 2) Performance of all aspects of regulatory compliance, IRB submission and quality assurance; 3) Ensuring fiscal and operational excellence leading to cost effectiveness; 4) Deployment of these facilities to outreach sites throughout Colorado and Wyoming. Leadership of >100 CICSRSR staff is provided by a Medical Director, Executive Director, Regulatory Affairs Manager, Financial Manager and Disease Site Team Leaders. The disease site teams of the CICSRSR are located on the 3rd floor of the Anschutz Cancer Pavilion. This places those individuals who interact directly with the patients and physicians in close proximity to both, thereby facilitating the trial enrollment process. Education and Training: The CICSRSR provides clinical trial education to investigators, research staff and clinic personnel via seminars and forums and has leveraged the educational facilities of our CTSA to do this cost effectively. Utilization: In 2010 CICSRSR provided service to 79 members from all UCCC Scientific Programs in support of 515 active (Investigator-initiated: 167; cooperative group: 198) clinical trials. A total of 9,911 subjects (1,112 to intervention and 8,799 to non-intervention) were accrued, a 55% increase since 2005. Therapeutic enrollments totaled 1,044, a 75% increase in the same period and represent 27% of newly registered cancer patients in the UCCC consortium and affiliate sites. Management and Finances: This resource is UCCC-managed. Currently, 2% of the operating budget comes from CCSG support and 40% from charge backs. CICSRSR requests $586,909 of CCSG support for 5% of its projected operating budget for the renewal period. Future directions: In the next funding period, we have plans to: 1) Lower barriers for investigator initiated trials by developing a novel Protocol Development Pathway; 2) Expedite protocol opening timelines by implementing findings from an ARRA grant we obtained in 2009; and 3) Expand operational support to outreach sites by enhanced telecommunication.