UTH

Coordinating Center for Clinical Trials

Advancing public health science by providing comprehensive trial coordination for small and large multicenter studies.

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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. Established in 1971, the CCCT has served as a full-service coordinating center for numerous nationwide multicenter clinical trials, both large and small. Our expertise spans 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.

Our focus is in leading and conducting multicenter clinical trials and research studies. We provide academic expertise and leadership coupled with full-service clinical trial management capabilities, data and adverse event monitoring, and statistical analysis support for publications. 

Our ultimate goal is in developing and sharing knowledge to improve patient care and public health. We accomplish this through the seamless integration of disease area expertise, innovative interventions, and sound clinical trial methodology.

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 and assist with large multicenter clinical trials, we also work with smaller and 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.

structure graphic 2

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 are happy to arrange a meeting 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. 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).

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.; 2019-2023 ($761,772).

The Benefits of Stroke Treatment Delivered by a Mobile Stroke Unit Compared with Standard Management by Emergency Medical Services (BEST-MSU) Trial

This is an observational, prospective, multicenter, alternating-week trial comparing Mobile Stroke Units with Emergency Medical Services management. The study enrolled 1,515 patients, of which the primary analysis focused on the 1,047 that were tPA-eligible. The overall goal of the study is to determine whether Mobile Stroke Units lead to lower disability after 90 days of stroke as well as fewer healthcare utilizations, and whether they are cost-effective.

Sponsored by Patient-Centered Outcomes Research Institute (PCORI), 2015-2022 ($7,997,773).

CATCH Healthy Smiles: An Elementary School Oral Health Intervention Trial

This is a cluster-randomized trial conducted in 26 schools. The purpose of this study is to clinically evaluate the effects of a school-based behavioral intervention, CATCH Healthy Smiles, to reduce the risk of dental caries in a cohort of kindergarten through 2nd grade (K-2) children serving low-income, ethnically-diverse children, to determine the impact of CATCH Healthy Smiles on child behavioral, psychosocial, and environmental outcomes beginning in K through 2nd grade, compared to children in the control schools and to examine the extent to which the child behavioral, psychosocial, and environmental factors mediate the improvements in child caries risk.

 Sponsored by National Institute of Dental and Craniofacial Research (NIDCR), 2019-2025 ($2,257,769)

Trauma Resuscitation with Low-Titer Group O Whole Blood or Products (TROOP Trial) 

TROOP is a pragmatic, multicenter, Bayesian, group-sequential, combined non-inferiority/ superiority, randomized clinical trial. The trial will enroll approximately 1100 injured patients with hemorrhagic shock anticipated to require massive blood transfusions. The overall goal of the study is to determine whether patients who are critically injured and need a large transfusion of blood should be given whole blood, or blood that has been separated into its individual components (red cells, platelets, plasma, etc.). Participants will be randomized to receive either whole blood (at least 8 units) or only component therapy and will be followed for 30 days to assess outcomes. 
Sponsored by National Heart, Lung, and Blood Institute (NHLBI), 2022-2027 ($653,807 in Y1). 

Gap-Based Milieu Biomarkers for Traumatic Brain Injury (GAMBIT-TBI) 

GAMBIT-TBI is a multi-center and multi-project diagnostic clinical study.?The goal of GAMBIT-TBI is to discover new blood- and imaging-based biomarkers to identify traumatic brain injury subphenotypes based on their recovery trajectories. Sponsored by Department of Defense US Army Medical Research Acquisition Activity, 2022-2026 ($865,872). 

Recent publications and collaborations

2023 

Gould KL, Nguyen T, Kirkeeide R, Roby AE, Bui L, Kitkungvan D, Patel MB, Madjid M, Haynie M, Lai D, Li R, Narula J, Johnson NP. Subendocardial and Transmural Myocardial Ischemia: Clinical Characteristics, Prevalence, and Outcomes With?and?Without Revascularization. JACC Cardiovasc Imaging. 2023 Jan;16(1):78-94. doi: 10.1016/j.jcmg.2022.05.016. Epub 2022 Sep 14. PMID: 36599572. 


2022 

Ye JB, Lai D: Empirical Power and Type I Error of Covariate Adjusted Nonparametric 
Methods. Mathematics and Statistics. 2022, in press. 

Chang R-J, Byrd-Williams C, Yamal J-M, Johnson K, Kelder S, Nelson S, Mofieh D, Sharma S. Design for a Cluster Randomized Controlled Trial to Evaluate the Effects of the CATCH Healthy Smiles School-based Oral Health Promotion Intervention among Elementary School Children. Contemporary Clinical Trials Communications, 2022 Dec 1; 30:101033.
 
Ye JB, Lai D, Moye LA, Davis BR: Applications of Covariate Adjusted Nonparametric 
Methods to CCTRN Clinical Trials. Communications in Statistics - Case Studies, Data 
Analysis and Applications. 2022, in press. 
 
Yang Y, Zhu H, Lai D: Estimation of Hurst Exponent for Sequential Monitoring of Clinical Trials with Covariate Adaptive Randomization. Contemporary Clinical Trials. 2022, in press. 
 
H., Lai, H., Mubashir, T., Shiwalkar, N. Ahmad, H., Balogh, J., Williams, G., Bouer, C. and Maroufy, V. (2022) Association of Pre-Admission Opioid Abuse and/or De-pendence on Major Complications in Traumatic Brain Injury (TBI) Patients Journal of Clinical Anesthesia, 79, 110719. 
 
Mubashir, T., Ahmad, H., Lai, H., Chaudhry, R. Maroufy, V., Balogh, J., Digbeu, B., Hwong, R., Chung, C., Williams, G., (2022) Effect of Obstructive Sleep Apnea on Outcomes after Traumatic Brain Injury: A Retrospective Cohort Analysis Journal of Neurocritical Care 1-8. 
 
Jacob, Parker SA, Bowry R, Czap Al, Yamal J-M, Wang M, Grotta JC. How frequent is the one-hour tPA infusion interrupted or delayed J of Stroke and Cerebrovascular Diseases, 2022 Jun;31(6):106471.
 
Czap AL, Hosseini MB, Singh N*, Nour M, Parker S, Kim Y, Restrepo L, Abdelkhaleq R, Salazar-Marioni S, Pham K, Bowry R, Rajan SS, Yamal J-M, Grotta JC, Saver JL, Giancardo L, Sheth SA. Machine learning automated detection of large vessel occlusion from Mobile Stroke Unit computed tomography angiography. Stroke, 2022 May;53(5):1651-6.
 
Bowry R, Parker SA, Bratina P, Singh N*, Yamal J-M, Rajan SS, Jacob AP, Phan K, Czap A, Grotta JC. Hemorrhage enlargement is more frequent in the first 2 hours: A Pre-hospital Mobile Stroke Unit Study. Stroke, 2022 Apr;53(7):2352-60. 
 
Asghari, A., Wall, K., Gill, M., Del Vecchio, N., Allahbakhsh, F., Wu, J., ... Maroufy, V. (2022). A novel group of genes that cause endocrine resistance in breast cancer identified by dynamic gene expression analysis. Oncotarget, 13, 600. 
 
Chen J, de la Rosa A, Lai D, Revere L, Lairson D, Wermuth P, Hui D: A National Survey 
of Palliative Care Team Compositions. Journal of Palliative Care. 2022, Vol. 37, 142-151 
 
Czap AL, Parker S, Yamal J-M, Wang M, Singh N*, Zou J*, Phan K, Rajan SS, Grotta JC, Bowry R. Immediate Recanalization of Large Vessel Occlusions by tPA Occurs in 28% of Patients Treated on a Mobile Stroke Unit. Stroke: Vascular and Interventional Neurology, 2022 Mar;2(2):e000101.
 
Mackey J, Yamal J-M, Parker SA, Silnes K, Rajan SS, Jacob AP, Wang M, Singh N*, Jones WJ, Spokoyny I, Navi BB, Saver JL, Grotta JC. Golden hour treatment with tissue plasminogen activator in the BEST-MSU Study. Stroke, in press.
 
Turc G, Haziahmetovic M, Walter S, Churilov L, Larsen K, Katsanos AH, Zhao H, Davis SM, Grotta JC, Yamal J-M, Bowry R, Hussain MS, Uchino K, Helwig SA, Weber J, Nolte CH, Kunz A, Steiner T, Sacco S, Ebinger M, Tsivgoulis G, Fabbender K, Audebert H. Mobile Stroke Unit or usual care for acute ischemic stroke management: a systematic review and meta-analysis. JAMA Neurology, 2022 Feb 7;79(3):281-290.
 
Du XL, Simpson LM, Osani MC, Yamal J-M, Davis BR. Risk of developing Alzheimer’s disease and related dementias in ALLHAT trial participants receiving diuretic, ACE-inhibitor, or calcium-channel blocker with 18 years of follow-up. Journal of Alzheimers Disease & Parkinsonism, 2022 Jan;12(3):541. 
 
Sharma S, Kelder S, Yamal J-M, Chuang R-J, Byrd-Williams C, Bona G, Bajaj N, Brito F*, Neumann AS. Development and feasibility testing of CATCH Healthy Smiles, an oral health promotion intervention for prevention of dental Caries among elementary school children. Journal of School Health, 2022 Jan;92(1):20-30. 
 
Xia L, Chen B, Lai D: Sequential Monitoring Clinical Trial by Conditional Power under Drift Fractional Brownian Motion. Communications in Statistics - Simulation and Computation. 2022, in press 
 
Kaushal S, Hare JM, Shah AM, Pietris NP, Bettencourt JL, Piller LB, Khan A, Snyder A, Boyd RM, Abdullah M, Mishra R, Sharma S, Slesnick TC, Si SM, Chai PJ, Davis BR, Lai D, Davis ME, Mahle WT: Autologous Cardiac Stem Cell Injection in Patientswith Hypoplastic Left Heart Syndrome (CHILD Study). Pediatric Cardiology. 2022. 

2021 

Rajan S, Wang M, Singh N*, Jacob AP, Parker SA, Czap AL, Bowry R, Grotta JC, Yamal J-M§. Retrospectively collected EQ-5D-5L data as valid proxies for imputing missing information in longitudinal studies, Value in Health, 2021 Dec 1;24(12):1720-7. 
 
Mann LK, Won JH, Patel R, Bergh EP, Garnett J, Bhattacharjee MB, Narayana PA, Jain R, Fletcher RA, Lai D, Papanna R: Allografts for Skin Closure during In-Utero Spina Bifida Repair in a Sheep Model. Journal of Clinical Medicine. 2021, Vol. 10 (21). 
 
Grotta JC†, Yamal J-M†, Parker SA†, Rajan SS, Gonzales NR, Jones WJ, Alexandrov AW, Navi BB, Nour M, Spokoyny I, Mackey J, Persse D, Jacob AP, Wang M, Singh N*, Alexandrov AV, Fink ME, Saver JL, English J, Barazangi N, Bratina PL, Gonzalez M, Schimpf BD, Ackerson K, Sherman C, Lerario M, Mir S, Im J, Willey JZ, Chiu D, Eisshofer M, Miller J, Ornelas D, Rhudy JP, Brown KM, Villareal BM, Gausche-Hill M, Bosson N, Gilbert G, Collins SQ, Silnes K, Volpi J, Misra V, McCarthy J, Flanagan T, Rao CPV, Kass JS, Griffin L, Rangel-Gutierrez N, Lechuga E, Stephenson J, Phan K, Sanders Y, Noser EA, Bowry R. Prospective Multicenter Controlled Trial of Mobile Stroke Units. New England Journal of Medicine, 2021 Sep 9;385(11):971-81. 
 
Yang Y, Zhu H, Lai D: Estimating Conditional Power for Sequential Monitoring of  
Covariate Adaptive Randomized Designs: The Fractional Brownian Motion Approach. Fractal and Fractional, 2021, Vol. 5, No. 3, 114. 
 
Chacon-Alberty L, Perin E, Willerson JT, Gahremanpour A, Bolli R, Yang PC, Traverse J, Lai D, Pepine C, Taylor DA: Peripheral Blood Biomarkers Associated with Improved Functional Outcome in Patients with Chronic Left Ventricular Dysfunction: A Biorepository Evaluation of the FOCUS-CCTRN Trial. Frontiers in Cardiovascular Medicine, section Heart Failure and Transplantation. 2021, Vol. 8. 
 
Kitkungvan D, Johnson NP, Kirkeeide R, Haynie M, Carter C, Patel MP, Bui L, Madjid M, Mendoza P, Roby AE, Hood S, Zhu H, Lai D, Sdringola S, Gould KL: Design and Rationale of The Randomized Trial of Comprehensive Life Style Modification, Optimal Pharmacological Treatment and Utilizing PET Imaging for Quantifying and Managing Stable CoronaRy ArterY Disease (The CENTURY Study). American Heart Journal.  2021, Vol. 237, 135-146. 

Jacob A, Wang M, Okpala M, Yamal J-M, Grotta JC, Parker SA,. Dosing Tissue Plasminogen Activator on a Mobile Stroke Unit:  Comparison Between Estimated and Hospital-Measured Weights. J of Neuroscience Nursing. 2021 Aug 1;53(4):166-9.
 
Bolli R, Mitrani RD, Hare JM, Pepine CJ, Perin EC, Willerson JT, Traverse JH, Henry 
TD, Yang PC, Murphy MP, March KL, Schulman IH, Ikram S, Lee DP, OBrien C, Lima 
JA, Ostovaneh MR, Ambale-Venkatesh B, Lewis G, Khan A, Bacallao K, Valasaki K, Long-somboon B, Gee AP, Richman S, Taylor DA, Lai D, Sayre SL, Bettencourt J, Vojvodic RW, Cohen ML, Simpson L, Aguilar D, Loghin C, Moye L, Ebert RF, Davis BR, Simari RD for the Cardiovascular Cell Therapy Research Network (CCTRN): A Phase II Study of Autologous Mesenchymal Stromal Cells and c-kit+ Cardiac Progenitor Cells, Alone or in Combination, in Patients with Ischemic Heart Failure: The CCTRN CONCERT-HF Trial. European Journal of Heart Failure. 2021, Vol. 23, 661-674. 
 
Chen J, de la Rosa A, Lai D, Revere L, Lairson D, Wermuth P, Hui D: Cancer Center Executives Attitudes towards Palliative Care Integration in the United States. BMJ Supportive & Palliative Care. 2021, Vol. 23, 661-674. 
 
Yu J, Lai D: Interim Monitoring of Sequential Estimation-adjusted Urn Model with Sample Size Re-estimation. The Canadian Journal of Statistics. 2021, https://doi.org/10.1002/cjs.11609 
 
Yamal J-M§†, Aisiku IP†, Hannay HJ§, Brito FA*, Robertson CS. Disability Rating Scale in the First Few Weeks After a Severe TBI as a Predictor of 6-month Functional Outcome. Neurosurgery. 2021 Feb 16;88(3):619-26. 

Yamal J-M§, Parker SA, Jacob A, Rajan SS, Bowry R, Bratina P, Wang M, Nour M, Mackey J, Collins S, Jones W, Schimpf B, Ornelas D, Spokoyny I, Im JF, Gilbert G, Eisshofer M, Grotta JC. Successful Conduct of an Acute Stroke Clinical Trial During COVID. PLOS ONE, 2021 Jan 15;16(1):e0243603.
 
Gould KL, Kitkungvan D, Johnson NP, Nguyen T, Kirkeeide R, Bui L, Patel MB, Roby AE, Madjid M, Zhu H, Lai D. Mortality Prediction by Quantitative PET Perfusion Expressed as Coronary Flow Capacity With and Without Revascularization. JACC Cardiovasc Imaging. 2021 May;14(5):1020-1034. doi: 10.1016/j.jcmg.2020.08.040. Epub 2020 Nov 18. PMID: 33221205. 

Contact us

Interested in collaborating?

The University of Texas Health Science Center
School of Public Health
1200 Pressler St., 8th and 9th Floor
Houston, Texas 77030

Phone: 713-500-9529
Email: shelly.l.sayre@uth.tmc.edu 

  • TROOP Trial

    Trauma Resuscitation with Low-Titer Group O Whole Blood or Products

    The purpose of the study is to determine whether patients who are critically injured and need a large transfusion of blood should be given whole blood, or blood that has been separated into its individual components (red cells, platelets, plasma, etc.)

    READ MORESPH - CCCT - TROOP Trial

    Blood bags stacked on top of each other
  • New Research

    Patients treated by mobile stroke units had better outcomes, according to national study published in New England Journal of Medicine (NEJM) publication: "Patients treated by mobile stroke units had better outcomes”

    Center Director Jose-Miguel Yamal, PhD, co-primary author and lead of the data coordinating center for the trial, hopes this research will encourage embedding mobile stroke units into the EMS system.

    READ MORESPH - CCCT - MOBILE STROKE UNIT

    Dr. Jose-Miguel Yamal
  • ELPIS II Trial

    Evaluation of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart Syndrome.

    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.

    READ MORESPH - CCCT - ELPISII

    Image sourced from Canva
  • DCM-II Trial

    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.

    This research study is being conducted to determine whether giving allo hMSCs to patients with heart muscle damage is safe. We will also examine whether this study drug improves heart function and if an individual’s genotype (genetics) plays a role in determining his/her response to allo hMSC therapy.

    READ MORESPH - CCCT - DCMII

    Image sourced from Canva
  • CHILD Trial

    Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome: An Open Label Pilot Study

    This study aims to test how safe and effective autologous ckit+ cell therapy is for managing hypoplastic left heart syndrome. It is hoped that by injecting these stem cells into the right ventricle of the heart, that there will be better right heart pumping function as the child gets older. 

    READ MORESPH - CCCT - HLHS

    Image sourced from Canva
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