Clinical Services - Colorado Prevention Center

Colorado Prevention Center

The Colorado Prevention Center (CPC) has a dual mission, which includes maintaining a large clinical trials research base, as well as programs that translate the findings of these studies into improving the health of the citizens of the State of Colorado.

1. Clinic Affairs Manager: Kathleen Castleman, RN, CCRC
The Colorado Prevention Center's clinical staff consists of RNs and certified technicians specializing in clinical research. Our staff members have expertise in various fields with an emphasis on diabetes and cardiovascular research. The department offers these clinical services:
a. Nursing services-4 full-time RNs on staff who are experienced in diabetes, hypertension, cardiovascular disease, neurology, dialysis, and osteoporosis.
b. Laboratory support-A full-time certified laboratory technician processes samples.
c. Retinal photography-A certified retinal photographer uses a Zeiss FF4 on site.
d. Exercise testing-A technician operates a Quinton 5000 treadmill machine with 12-lead ECG on site.
e. A certified technician on site performs cardiac ultrasound-Two-dimensional ultrasound.

2. Data Coordinating Center Manager: Anne Esler, Ph.D.
The Data Coordinating Center (DCC) supports the clinical trials and academic research efforts of the CPC by providing expertise in data management, statistical analysis and statistical programming. We offer a wide range of services including study design, protocol development, CRF design, data entry, data analysis, statistical programming, and report generation. 2001 Highlights:
· Contributed to abstracts or publications in the areas of:
o Diabetes
o Peripheral arterial disease
o Health care utilization
o Dental disease and therapies
o Renal disease
· Collaborated with leading statisticians from Boston University to simulate power and sample size estimates
· Began a three-year project to oversee DSMB activities for a large, multi-center trial
· Provided randomization codes for several multi-center studies
· Contributed to NIH and tobacco fund grant applications
· Continued data management and analysis for many clinical studies in the areas of diabetes, hypertension, seizure disorders, dental disease, peripheral arterial disease and disease prevention in collaboration with investigators from CPC, UCD, University of CO School of Dentistry and Denver Health
· Future DCC Activities
Began the process of closing out a two year study of a seizure medication (to be completed in 2002)
Will become the data coordinating center for a multi-center quality of life study (contract to be finalized in 2002)
Will become the data coordinating center for the Denver Health hypertension study (grant approved 2002)
Formalized relationship with Data Coordinating Center at National Jewish.

Unique Services of the DCC

3. Data Management and Statistics
Using documented data management procedures and double data entry, our data management team provides a high level of data accuracy and completeness in compliance with regulatory guidelines. Data management services offered by the CPC include case report form (CRF) design and database design, date entry and query generation, COSTART, MEDRA and WHO coding, data transfer in a variety of formats, and quality control audits.

The professional biostatisticians of the CPC support the statistical needs of our clients from study design to final report submission. Our statisticians are experienced with a variety of statistical techniques applicable to the analysis of clinical data including parametric and nonparametric methodology, linear, nonlinear and longitudinal analysis, logistic modeling, and time-to-event analysis. Our services include study design and sample size calculations, subject randomization, data analysis, and the generation of statistical reports and scientific publications.

4. DSMB Activities
The CPC coordinates the activities of Data Safety and Monitoring Boards (DSMB) for major pharmaceutical studies. The biostatisticians and programmers of the CPC are experienced in managing the flow of data between these boards and the study sponsors in accordance with current regulatory guidelines.

5. Prevention Manager: Laurel Petralia
This department manages our community-based prevention programs in the secondary prevention of diabetes and cardiovascular disease. The focus is both translational research as well as primary prevention interventions to Colorado communities.

6. Research Operations Manager: Nancy Gifford, RN
This department manages and monitors the single and multi-center clinical trials and prevention projects conducted by CPC on behalf of pharmaceutical companies, academic institutions, and government agencies. Our goal is to provide an efficient and comprehensive approach to the entire research operation process, and to produce the highest quality clinical trial management services available. Every project is assigned a dedicated project manager who works with a multi-disciplinary project team that includes clinicians (physicians, nurses), clinical monitors, data managers, biostatisticians, information management specialists, and administrative/financial support staff as needed.