Services Offered by the Coordinating Center

The CCCT has over a 45-year history of successfully coordinating large multicenter clinical trials and providing comprehensive services for these trials. Although our primary goal is to design large multi-center clinical trials, we also work on smaller single-site trials. Regardless of trial size and complexity, we provide high quality study design, monitoring, management, reporting, and interpretation of study findings.

• Study Design

  We have expertise in all phases of trials, including comparative effectiveness trials, adaptive trials, and futility trials. Specifically, we can help investigators with:

  • Hypothesis development and definition of study objectives
  • Selection of study outcome measures
  • Determination of an assessment schedule
  • Statistical design (comparative effectiveness, parallel group, factorial, cluster, cross-over, noninferiority, futility, seamless Phase II-III, SMART, MOST, etc)
  • Power analysis and estimation of a sample size

• Study Implementation

  Site Selection and Recruitment of Investigators and Centers
  Select sites so as to maximize patient safety, ensure high quality patient care, reflect the current practices of experienced medical practitioners, and provide a consistent clinical environment. The CCCT is experienced at recruiting and selecting contract clinical investigators and clinical centers qualified to enroll, treat, and follow a defined study population sample as well as adhere to a study protocol.
  Developing Protocols and Trial-Related Training Materials
  Work with sponsors, core laboratories, and the steering committees to develop study protocols, case report forms, and detailed manuals of operations. Provide training on recruiting, enrollment and randomization; clinical and laboratory procedures; and Web based data collection, entry, and transmission.
  Implementing Trial Management and Data Gathering Systems
  Implement and ensure a high quality, standardized, data gathering and trial management system for collecting all study data, monitoring study progress, providing feedback to participating components, and assessing study outcomes. The CCCT employs secure web-based data entry systems that include all data collection forms and allows study investigators to access their respective clinical site performance metrics.
  Assuring Quality Control
  Maintain quality control and monitor the performance status of the clinical centers, core laboratories, and other central units. This includes availability of performance and quality control reports on a secure website.
  Monitoring Recruitment and Providing Recruitment Resources
  Monitor patient recruitment by providing weekly reports to the clinical sites, sponsors, core laboratories, reading centers, and study product manufacturer or distributor during the recruitment phases. Additionally, maintain updated reports on a secure web site accessible to all units of the study. Serve as a central resource to retain high recruitment and participation rates by providing recruitment aids (video, posters, cards, etc.), participant and clinic newsletters, and study-wide suggestions. Manage newsletters and other study training, recruitment, and adherence aids on study websites where they are accessible to appropriate study components.
  Safety and Regulatory Oversight
  Provide for the timely monitoring of adverse effects and trial events to ensure patient safety; including the notification and reports provided to the sponsor(s), Data Safety and Monitoring Board, clinical investigators, and other appropriate agencies according to regulatory requirements. Ascertain and validate the cause of participant deaths and hospitalizations. Development of on-site or remote monitoring plan to ensure appropriate regulation of informed consent process, data integrity, device/product accountability, and regulatory documentation. Provide instruction on ethical treatment of human subjects and scientific integrity.

• Data Analysis and Dissemination

  Data Analysis
  The CCCT faculty and staff have in-depth knowledge and understanding of scientific issues related to the trial rationale and design including: the importance of the research question, knowledge of disease areas, and understanding of trial design and state-of-the-art analysis methods. The CCCT provides biostatistical expertise with best-practice methods for the analysis of clinical trial data. Novel statistical methods have also been developed to deal with more complex data when standard methods cannot be used. Our team has the ability to take appropriate leadership in preparation of scientific reports and manuscripts and publication and presentation of study findings and results.
  Data Science
  The Department of Biostatistics and Data Science has specific expertise in the development of prognostic and prediction models/algorithms using machine learning. Data scientists in our department can implement computationally intensive programs using efficient algorithms into trials.
  Disseminating Study Information
  Develop and execute plans for dissemination of trial results to professional groups, medical schools, the medical community, and the public. Target leaders in appropriate specialty practices and develop guidelines. Analyze data and assist in preparing papers and presentations as needed for study publications and presentations at scientific and professional society meetings.

• Trial Support

  The Investigators and staff of the CCCT have the personnel and technical expertise to design, organize, and successfully execute clinical trials from Phase I proof of concept trials to large-scale multicenter randomized controlled clinical trials. Our approach combines administrative support, with project management, data programming, and statistical expertise from seasoned personnel to provide leadership and collaboration for the operation of a first-class coordinating center.
  Administrative Support
  The CCCT has experienced staff responsible for the fiscal and budgetary affairs of clinical trial operations. This includes, subcontracts for patient care expenses to clinical centers and core laboratories. Professional meeting organization services are also provided (arrangement of hotel/meeting accommodations, production of meeting materials, honorarium management, etc.)
  Project Management
  The CCCT project management team has more than 100 years of experience in research and trial management. The team is skilled in the methods used to coordinate and manage a complex randomized clinical trial consisting of multiple clinics and or networks, core laboratories, reading centers, and drug distribution centers. These methods include those related to organizing and monitoring recruitment and follow-up of study patients from multiple clinical sites and networks. Additionally, this team has a strong appreciation for the importance, level, and timing of communication to successfully engage study personnel in a variety of activities needed for trial completion.
  Data Programming and Analysis
  The CCCT programming team is highly skilled in designing and developing web-based applications for data collection and randomization, and in executing plans for central data acquisition, harmonization, management, and analysis, including patient randomization and quality control measures. The programming team uses Microsoft .Net system development technologies to develop websites, applications, and reporting services. Clustered Microsoft SQL Server database instances are used by the team to provide large-scale data storage and retrieval services. The team uses STATA, SAS and SQL Server-integrated ‘R’ servers to provide data analysis services. To support these activities, The UTHealth School of Public Health (SPH) maintains its own raised floor data center and has access to two additional UTHealth data centers for additional capabilities and services. The SPH data center provides 10 gigabit network access speeds to the internet backbone, which is among the highest levels of network connectivity available to enterprise organizations. Advanced network monitoring technologies from Cisco Systems are employed to support SPH data center operations with diagnostic and corrective tools to monitor and maintain the network. The SPH is interconnected to other UTHealth data centers through distinct redundant-path fiber optic cabling to provide maximum uptime and reliability to the network. This facility provides research, academic, and administrative computing resources, with servers utilizing Windows and Linux operating systems. Systems and data are protected by redundant servers and storage arrays, encrypted cloud-based backups, and a multi-layer firewall. The ability to deploy public servers and provide the highest level of protection to corresponding project data is considered priority one both at UTSPH and the CCCT, which work in together in securing and proactively monitoring these systems.

The UT Health CCCT has the capability and expertise to work on many disease and public health research subjects. Some research areas the CCCT has experience in include:

 

Diseases

• Cancer (Cervical Cancer, Gastric Cancer, Anal Cancer)
• Cardiovascular Diseases (hypertension, hypercholesterolemia, heart failure)
• Diabetes
• Liver Disease
• Lung
• Transplantation (computerized interventions)
• Tobacco (new and emerging products)
• Obesity
• Ophthalmology (retinopathy, retinal ablative therapy)
• Parkinson’s
• Sickle Cell Anemia
• Stem Cell Therapy (in cardiovascular diseases)
• Stroke
• Trauma (including use of blood products in a trauma setting)
• Traumatic brain injury

 

Innovative Interventions

• Wearable Device Trials
• Smart Phone Based Intervention to Reduce Recidivism
• Strategies for recruitment of racial and ethnic diverse groups in clinical trials
• Randomized trial for an intervention to decrease sedentary behavior

Clinical Trial Methodology

• Adaptive randomization, seamless trial
• Group Sequential Monitoring

Bayesian Adaptive Design

Current Projects

Completed Projects