About the Coordinating Center for Clinical Trials
Welcome
The Coordinating Center for Clinical Trials (CCCT) provides full-service trial coordination for research studies. We handle the logistical and statistical challenges of coordinating small and large multicenter studies and research projects, allowing Investigators to focus on their patient-participants. Our expert team collaborates with investigators every step of the way – from study design and execution to the dissemination of trial findings. We invite you to learn more about our services, our team, and who we can expand your research, streamline your data collection, and manage the operations integral to your project.
Who we are
The UTHealth Coordinating Center for Clinical Trials (CCCT) has an established history of advancing science through coordinating clinical trials. Since our inception in 1971, the CCCT has served as a coordinating center for more than 25 nationwide multicenter clinical trials. Our expertise spans l research areas including biostatistics, epidemiology, clinical trials, data management, trial design, data science, computer science, bioinformatics, and genomics. The mission of the CCCT is to improve a broad spectrum of public health interests through the coordination of clinical trials, collaboration with clinical investigators, and the development of statistical and trial methodology.
Clinical trials are undergoing a revolution in the era of big data. Here at the CCCT, we have the capacity to undertake multifaceted clinical trials using complex and high-dimensional data gathered from sources including wearable devices and electronic medical records. Leveraging data that’s collected automatically or as part of the patient standard of care, allows for clinical trials that are more efficient and less costly to design.
Research interests
The CCCT has the capability and expertise to work on many topics of medical and public health interests.
Areas of expertise
- Cardiovascular
- Diabetes
- Kidney disease
- Stroke
- Sickle cell
- Ophthalmology
- Cell Therapy
- Trauma
- Rheumatology
- Neurology
- Dental
- Psychiatry
- Gastroenterology
- Pulmonary
- Pharmacokinetics
Innovative interventions
- Diet-drug trials
- Community-based clinics
- Dissemination of trial results
- Wearable device trials
- Smartphone-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
- Factorial design
- Bayesian adaptive design
- Adaptive randomization, seamless trial
- Group sequential monitoring
Services offered by the CCCT
50 years of successfully providing comprehensive services and coordinating large multi-center clinical trials
Although our primary goal is to design large multicenter 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.
Our model (below) highlights our capabilities and can be scaled to fit the needs of a given research project. Take a look at what we can do for you.
Consulting
First hour: free of charge
Collaborations
Free for collaboration on the grant application, but the service provider and his/her associates’ effort and other needs for the proposed project should be appropriately budgeted in the grant application.
We recommend
- For a large program or center grant, usually, 10-20% of the overall project budget is suggested for data management, modeling, and analysis, which depends on the size and complexity of collected data from the project.
- For smaller, multicenter (two or more) projects, we are happy to meet with you to discuss the project and provide a quote for services that meet the needs of the trial.
Trials and projects
Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
Read about ALLHAT here.
Ancillary Study - Sustained Blood Pressure Control and Progression of Multimorbidity in ALLHAT NHLBI R01 (Subcontract from Duke University. 2016-2020. ($316,284).
Ancillary Study. Long-term Benefits & Harms of Antihypertensive Drugs in the Elderly: Up to 22-year Follow-Up of ALLHAT Trial Participants. Xainglin Du, PI. NIA. 2018-2022 ($1,324,000).
Evaluation of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial (ELPIS II)
The ELPIS II trial is being conducted by a consortium of clinical centers in the US who routinely direct surgical and follow up care for children with hypoplastic left heart syndrome (HLHS). The trial is testing whether Lomecel-B (containing human mesenchymal stem cells) is safe and effective in treating patients with HLHS when administered during the child’s second staged palliative surgery.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI); 2020-2025 ($1,862,493).
A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Transendocardial Injection of Allogeneic-MSC versus Placebo in Patients with Non-Ischemic Dilated Cardiomyopathy (DCM II)
The purpose of the DCM II study is to determine whether giving allogeneic mesenchymal stem cells to patients with heart muscle damage is safe and whether this improves heart function. Additionally, this study will examine whether an individual’s genetics plays a role in determining his/her response to the cell therapy. Four US clinical centers are participating.
Sponsored by the US Department of Defense; 2020-2024 ($4,778,129).
Cardiovascular Cell Therapy Research Network (CCTRN) Data Coordinating Center
The CCTRN is a cooperative clinical network consisting of seven clinical centers in the United States dedicated to studying stem cell therapy for the treatment of cardiovascular and peripheral arterial disease. The Network includes expert researchers with experience in cardiovascular and peripheral vascular care at seven stem cell centers in the United States. CCTRN is currently planning and conducting multicenter study phase II clinical trials.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI; -Cooperative Agreement-2UM1HL087318-06); 2012-2021 ($63,000,000).
Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome (CHILD)
The CHILD study is assessing the safety, feasibility, and efficacy of intramyocardial delivery of c-kit+ cells in patients with hypoplastic left heart syndrome under 6 months of age.
Sponsored by the Marcus Foundation Inc.; 2019-2021 ($609,279).
Phase III, multicenter, prospective cluster-randomized comparative effectiveness study in tPA-eligible patients (patients with ischemic stroke)
The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS) to a CSC ED for evaluation and treatment (Standard Management-SM).
Sponsored by: Memorial Hermann Health System; 2014-2022 ($2,336,999).
Recent publications
Contact us
Interested in collaborating?
The University of Texas Health Science Center
School of Public Health
1200 Herman Pressler, 8th and 9th Floor
Houston, Texas 77030
Phone: 713-500-9529
FAX: 713-486-0981
Email: shelly.l.sayre@uth.tmc.edu
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The purpose of this study is to test whether Lomecel-B works in treating patients with HLHS and to gather additional information about the safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient.
