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.

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).

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).

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 ($1,108,164 in Y1)

Recent publications and collaborations

Grotta JC, Yamal JM, 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. N Engl J Med. 2021 Sep 9;385(11):971-981. doi: 10.1056/NEJMoa2103879. PMID: 34496173.

 

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, in press.

 

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.

 

Wang M, Rajan SS, Jacob AP, Singh N*, Parker SA, Bowry R, Grotta JC, and Yamal J-M. Retrospective collection of 90-day modified Rankin Scale is accurate. Clinical Trials. 2020 Dec; 17(6):637-43.

 

Chacon Alberty L, Perin EC, Willerson JT, Gahremanpour A, Bolli R, Yang PC, Traverse JH, Lai D, Pepine CJ, 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. Front Cardiovasc Med. 2021 Sep 3;8:698088. doi: 10.3389/fcvm.2021.698088. PMID: 34540912; PMCID: PMC8446350.

 

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, O'Brien C, Lima JA, Ostovaneh MR, Ambale-Venkatesh B, Lewis G, Khan A, Bacallao K, Valasaki K, Longsomboon B, Gee AP, Richman S, Taylor DA, Lai D, Sayre SL, Bettencourt J, Vojvodic RW, Cohen ML, Simpson L, Aguilar D, Loghin C, Moyé L, Ebert RF, Davis BR, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). A Phase II study of autologous mesenchymal stromal cells and c-kit positive cardiac cells, alone or in combination, in patients with ischaemic heart failure: the CCTRN CONCERT-HF trial. Eur J Heart Fail. 2021 Apr;23(4):661-674. doi: 10.1002/ejhf.2178. Epub 2021 Apr 13. PMID: 33811444; PMCID: PMC8357352.

 

Kitkungvan D, Johnson NP, Kirkeeide R, Haynie M, Carter C, Patel MB, 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 lifestyle modification, optimal pharmacological treatment and utilizing PET imaging for quantifying and managing stable coronary artery disease (the CENTURY study). Am Heart J. 2021 Jul;237:135-146. doi: 10.1016/j.ahj.2021.03.012. Epub 2021 Mar 21. PMID: 33762179.

 

Wijarnpreecha K, Li F, Xiang Y, Xu X, Zhu C, Maroufy V, Wang Q, Tao W, Dang Y, Pham HA, Zhou Y, Li J, Zhang X, Xu H, Taner CB, Yang L, Tao C. Nonselective beta-blockers are associated with a lower risk of hepatocellular carcinoma among cirrhotic patients in the United States. Aliment Pharmacol Ther. 2021 Aug;54(4):481-492. doi: 10.1111/apt.16490. Epub 2021 Jul 5. PMID: 34224163.

 

Sander AM, Clark AN, Arciniegas DB, Tran K, Leon-Novelo L, Ngan E, Bogaards J, Sherer M, Walser R. A randomized controlled trial of acceptance and commitment therapy for psychological distress among persons with traumatic brain injury. Neuropsychol Rehabil. 2021 Aug;31(7):1105-1129. doi: 10.1080/09602011.2020.1762670. Epub 2020 May 15. PMID: 32408846.

 

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.

 

Bowling CB, Sloane R, Pieper C, Luciano A, Davis BR, Simpson LM, Einhorn PT, Oparil S, Muntner P. Association of Sustained Blood Pressure Control with Lower Risk for High-Cost Multimorbidities Among Medicare Beneficiaries in ALLHAT. J Gen Intern Med. 2021 Aug;36(8):2221-2229. doi: 10.1007/s11606-021-06623-w. Epub 2021 Feb 9. PMID: 33564944; PMCID: PMC8342657.

 

Attipoe-Dorcoo S, Delgado R, Lai D, Gupta A, Linder S. Analysis of Annual Costs of Mobile Clinics in the Southern United States. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720980623. doi: 10.1177/2150132720980623. PMID: 33349118; PMCID: PMC7758644.

 

Bolli R, Perin EC, Willerson JT, Yang PC, Traverse JH, Henry TD, Pepine CJ, Mitrani RD, Hare JM, Murphy MP, March KL, Ikram S, Lee DP, O'Brien C, Durand JB, Miller K, Lima JA, Ostovaneh MR, Ambale-Venkatesh B, Gee AP, Richman S, Taylor DA, Sayre SL, Bettencourt J, Vojvodic RW, Cohen ML, Simpson LM, Lai D, Aguilar D, Loghin C, Moyé L, Ebert RF, Davis BR, Simari RD; Cardiovascular Cell Therapy Research Network (CCTRN). Allogeneic Mesenchymal Cell Therapy in Anthracycline-Induced Cardiomyopathy Heart Failure Patients: The CCTRN SENECA Trial. JACC CardioOncol. 2020 Nov;2(4):581-595. doi: 10.1016/j.jaccao.2020.09.001. Epub 2020 Dec 22. PMID: 33403362; PMCID: PMC7781291.

 

Brock CO, Bergh EP, Moise KJ Jr, Johnson A, Hernandez-Andrade E, Lai D, Papanna R. Middle Cerebral Artery Doppler Velocimetry for the Diagnosis of Twin Anemia Polycythemia Sequence: A Systematic Review. J Clin Med. 2020 Jun 4;9(6):1735. doi: 10.3390/jcm9061735. PMID: 32512796; PMCID: PMC7355756.

 

Williams G, Maroufy V, Rasmy L, Brown D, Yu D, Zhu H, Talebi Y, Wang X, Thomas E, Zhu G, Yaseen A, Miao H, Leon Novelo L, Zhi D, DeSantis SM, Zhu H, Yamal JM, Aguilar D, Wu H. Vasopressor treatment and mortality following nontraumatic subarachnoid hemorrhage: a nationwide electronic health record analysis. Neurosurg Focus. 2020 May 1;48(5):E4. doi: 10.3171/2020.2.FOCUS191002. PMID: 32357322.

 

Jansen JO, Wang H, Holcomb JB, Harvin JA, Richman J, Avritscher E, Stephens SW, Truong VTT, Marques MB, DeSantis SM, Yamal JM, Pedroza C. Elicitation of prior probability distributions for a proposed Bayesian randomized clinical trial of whole blood for trauma resuscitation. Transfusion. 2020 Mar;60(3):498-506. doi: 10.1111/trf.15675. Epub 2020 Jan 22. PMID: 31970796; PMCID: PMC7079110.

 

Juraschek SP, Simpson LM, Davis BR, Shmerling RH, Beach JL, Ishak A, Mukamal KJ. The effects of antihypertensive class on gout in older adults: secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. J Hypertens. 2020 May;38(5):954-960. doi: 10.1097/HJH.0000000000002359. PMID: 31977576; PMCID: PMC7244334.

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 

  • New Research

    Patients treated by mobile stroke units had better outcomes, according to national study published in NEJM

    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
  • 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
  • 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
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