The Center for Clinical Trials & Data Coordination (CCDC) specializes in clinical trial design, conduct, coordination, and analysis and utilizes the data management and biostatistical infrastructure of the CRHC-DC.
Center for Clinical Trials and Data Coordination (CCDC)
The Center for Clinical Trials and Data Coordination (CCDC) aims to be a national leader in the design, conduct, coordination, and analysis of clinical trials. Established in 2015, the CCDC guides clinical trials from conception to closeout, employing a system that seamlessly integrates critical elements of clinical trial management including: electronic data capture, eligibility & randomization, drug & external data tracking, safety reporting, outcome adjudication, data & safety monitoring, statistical analysis & reporting, data sharing, and regulatory compliance. The CCDC uses clinical research data coordinators who function as conduits between the clinical, data, and statistical teams of each study. The coordinators oversee protocol development & training, on-site and centralized study monitoring, safety reporting, and regulatory compliance. This alleviates the burden on the clinical side of the study, thereby facilitating more timely data analysis, publication, and data sharing. Its emphasis on standardization and streamlining, combined with the established statistical analysis and data management infrastructure of the Center for Research on Heath Care Data Center, makes the CCDC the preeminent place for comprehensive clinical trials-related support.
Capabilities
The Center for Clinical Trials and Data Coordination (CCDC) provides comprehensive clinical trial management support for clinical trials. We have expertise in biostatistics, data management, and study coordination.
Biostatistics
The CCDC partners with the Center for Research on Health Care (CRHC) Data Center Biostatistics Core to provide expertise in the development and execution of statistical analysis plans. The Core also includes MS and BS-level statisticians who contribute significantly to developing and conducting analyses as well as interpreting and writing for publications and grant applications. The Core statisticians also have experience implementing data sharing plans with numerous NIH data repositories.
Data Management
We work with the CRHC Data Center Data Management Core to implement state of the art data management systems that can be accessed from any electronic device. Each data management system is designed to facilitate the workflow of the study. We work with the investigative team to develop the case report form and an integrated tracking system. Our data management systems have the capability to incorporate electronic health record data and are developed using .NET to create the interface and SQL Server for the database.
Our team can create a data management system that adheres to current data security practices, including the guidelines for FDA's Title 21 CFR Part 11 federal regulations.
Study Coordination
The CCDC utilizes clinical research data coordinators who function as conduits between the clinical, data, and statistical teams of each study. They develop, implement, and oversee study-specific procedures for:
Protocol development & training
On-site and centralized study monitoring
Safety reporting
Regulatory compliance
electronic Trial Management System (eTMS)
Projects & Collaborations
Project List
Website:CaRISMA Role: DCC Design: Purpose: This comparative effectiveness trial among adult subjects with Sickle Cell Disease (SCD) is designed to determine whether: 1) cognitive behavioral therapy (cCBT) will confer greater benefit on daily pain intensity and pain interference at 6 months, compared to medical education (m-education); and, 2) cCBT will confer greater benefit on depressive symptoms, health care utilization, and opioid misuse behaviors compared to m-education. Planned Enrollment: 350 randomized to receive either cCBT (n = 175) or m-Education (n = 175). Actual Enrollment: Recruitment pending Number of Sites: Multicenter study- 5 sites and 3 SCD Community Based Organizations along with virtual subject enrollment
Website:AFib LITT Role: DCC Design: Purpose: This randomized clinical trial is designed to evaluate the effect of a smartphone-based intervention on health outcomes in people with the heart disease called atrial fibrillation. Intervention participants will receive a smartphone with an application (or app) called a relational agent, which simulates conversation. In addition they will receive an AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the smartphone. Control participants will also receive a smartphone with WebMD. Planned Enrollment: 240 subjects > 21 years of age with Atrial Fibrillation on anticoagulants. Actual Enrollment: Recruitment commenced January 22, 2020 Number of Sites: Single center study within 8 UPMC Health System clinics
Website:FAM ACT Role: DCC Design: Purpose:The objective of this experimental study is to compare the effectiveness of a novel program—Family Partners for Health Action (FAM-ACT)—to individual patient-focused diabetes self-management education and care management (I-DSME/CM). This is a randomized comparative effectiveness trial comparing two interventions. Planned Enrollment: 268 dyads (adult patient with diabetes and support person) Actual Enrollment: Recruitment commenced September 26, 2019 Number of Sites: Single Center study
Website:VWDMin Role: DCC Design: Purpose: The purpose of this Phase III multicenter prospective, randomized, crossover arm trial is to compare recombinant von Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in women with von Willebrand disease.
Subjects randomized to Group I will receive Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles. Subjects randomized to Group II will receive Arm B, then be crossed over to Arm A. Planned Enrollment: 60 women age 18-45 years with mild to moderate VWD and menorrhagia Actual Enrollment: Ongoing Number of Sites: 19 clinical sites
Website:STERIO-SCD Role: DCC Design: Purpose: phase II, multicenter trial to evaluate the safety and tolerability of 12-weeks of treatment with riociguat versus placebo in high-risk patients with sickle cell disease (SCD).
100 adults with sickle cell disease at high risk of sickle cell complications. Planned Enrollment: 100 adults with sickle cell disease at high risk of sickle cell complications. Actual Enrollment: Ongoing; commenced in Spring 2017 Number of Sites: Up to 19 clinical sites
Website:TAME-PKD Role: DCC Design: Purpose: phase II, multicenter clinical trial to evaluate the safety and tolerability of metformin versus placebo over a two-year period.
Participants will be randomized in a 1:1 ratio to receive either placebo or metformin, titrated to 1000 mg twice daily, or maximal tolerated dose, over a 6-week period. Planned Enrollment: 96 adults aged 18-60 with ADPKD Actual Enrollment: Closed to recruitment as of 12/12/2018
Anticipate study closeout December 2020 Number of Sites: 2
Website:HALT PKD Study A Role: DCC Design: Purpose: to assess the efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD).
2x2 factorial design where participants were randomized to one of four study arms: 1) combination ACE-I/ARB with standard blood pressure (BP) control (systolic 120-130 and diastolic 70-80 mm Hg); 2) ACE-I monotherapy with standard BP control; 3) combination ACEI/ARB treated to a low BP target (systolic 95-110 and diastolic 60-75 mm Hg); and 4) ACE-I treated to the low BP goal. The primary outcome was the percent change in total kidney volume measured by magnetic resonance (MR) imaging. Planned Enrollment: 558 participants with early disease defined by GFR >60 mL/min/1.73 m2. Actual Enrollment: Completed Number of Sites: 7
Website:HALT PKD Study B Role: DCC Design: Purpose: to assess the efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD).
Participants were randomized to 1) ACE-I/ARB combination therapy or 2) ACE-I monotherapy to assess impact on composite endpoint of time to a 50% reduction of baseline eGFR, ESRD or death. Planned Enrollment: 486 participants with moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2. Actual Enrollment: Completed Number of Sites: 7
