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The mission of the Coordinating Center for Clinical Trials (CCCT) is the coordination of large multi-center controlled clinical trials. The goal of the Center is to identify important public health problems and design large clinical trials to study the efficacy of appropriate interventions, including the collection, management, reporting, and interpretation of study findings.
History
Since its inception in 1971 by members of the Biostatistics faculty of The University of Texas School of Public Health, the CCCT has played a leading role in clinical trials research by serving as a coordinating center for over 20 nationwide multicenter clinical trials. The CCCT’s primary function is to provide and coordinate all operations, procedures, and activities of large-scale randomized controlled clinical trials. These include:
- Study design, implementation, and oversight of the study protocol and procedures
- Project management, data and safety monitoring, and quality assurance
- Contracting of services for trial (core lab analysis, meeting organization, training)
- Regulatory guidance (compliance and clinical monitoring)
- Statistical analysis, interpretation, publication management, and dissemination of results
Services
Services Offered by the Coordinating Center
The CCCT has a 40-year history of successfully coordinating large multicenter clinical trials and providing comprehensive services for these trials. The following are some of these services:
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. Experienced at recruiting and selecting contract clinical investigators and clinical centers qualified to enroll, treat, and follow a defined study population sample and willing and able to adhere to a randomized clinical trial protocol and follow its procedures.
Developing Protocols and Trial-Related Training Materials
Work with sponsors, core laboratories, and the steering committees to development 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 insure 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 that allows study investigators to access their respective clinic s study data and performance history.
Assuring Quality Control
Maintain quality control at, and monitor the performance status of, the clinical centers and the core laboratories and other central units. Make available performance and quality control reports on a secure web site.
Monitoring Recruitment and Providing Recruitment Resources
Monitor patient recruitment by providing weekly reports to the clinical sites, the sponsor, core laboratories, reading centers, and the drug distribution center during the recruitment phases, and maintain updated reports on a secure web site accessible to all units of the study. Serve as a central resource to maintain high recruitment and participation rates by providing recruitment aids (video, posters, cards, etc.), participant and clinic newsletters, and study-wide suggestions. Maintain newsletters and other study training, recruitment, and adherence aids on study web sites where they are accessible to appropriate study components.
Safety and Regulatory Oversight
Provide for the timely monitoring of adverse effects and trial events to insure patient safety, including notification and reports to the sponsor, the Data Safety and Monitoring Board, and to other appropriate agencies according to regulatory requirements. Monitor adverse effects of therapies. This includes reporting clinical data to regulatory agencies and clinical alerts to clinical investigators in a timely fashion. Ascertain and validate the cause of participant deaths and hospitalizations. Ensure and monitor the acquisition of informed consent from all patients prior to enrollment and throughout the trial in the event of protocol changes or ancillary studies. Provide instruction on ethical treatment of human subjects and scientific integrity.
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 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
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, management, and analysis, including randomization of patients and quality control measures. The Computing Center is a fully networked system of servers, storage arrays, and peripherals. This state-of-the-art facility provides research, academic, and administrative computing power with servers for the OpenVMS, UNIX, and Windows 2003/2008 operating systems. The data and computing processes are protected by redundant servers, storage arrays, tape backups, and multiple firewall levels. A variety of tools help us develop web applications and web sites. These include the Microsoft .NET technology and ColdFusion for developing web applications, Dreamweaver for developing web sites, Photoshop and Fireworks for developing web graphics, and FastStats Analyzer for reading web log files to produce web activity statistical reports.
Statistical Support
The CCCT Investigator team has an in depth knowledge and understanding of scientific issues related to the trial rationale and design; including the importance of the research question, knowledge of cardiovascular disease, and understanding of trial design and state-of-the-art analysis methods.
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.
Research Projects
Current Projects
To facilitate and encourage use of ALLHAT’s dataset by outside investigators to pursue timely scientific questions related to hypertension and hypercholesterolemia, the National Heart, Lung, and Blood Institute has funded a new phase entitled ALLHAT Continuation and Outreach. Its purposes are to:
- develop processes that assure optimal scientific contributions, build on to-date publications and explore new areas, in part through involving appropriate consultants as leaders of relevant scientific areas
- encourage productive interdisciplinary collaboration and mentor early-stage investigators from a diverse set of institutions, especially investigators with no recent history of participating in ALLHAT
- promote awareness of the ALLHAT resources among research and clinical communities
Sponsored by the National Heart, Lung and Blood Institute (NHLBI); 2011-2016 ($5,000,000). Publications (PDF)
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); 2012-2019 ($63,000,000).
CCTRN Publications. (PDF)
A randomized controlled clinical trial to compare standard therapy (erythrocyte transfusions) with alternative therapy (hydroxyurea) for the maintenance of lowered TCD velocities in 118 pediatric subjects with sickle cell anemia and abnormal pre-treatment TCD velocities in 26 centers. Sponsored by the National Heart, Lung and Blood Institute (NHLBI); 2010-2014 ($3,377,396).
A clinical trial to compare basal insulin plus the addition of the GLP-1 analogue, exenatide, with basal insulin plus the addition of prandial insulin (insulin glulisine) on glycemic variability in 130 diabetic patients in 12 centers; Sponsored by Sanofi-Aventis; 2011-2013 ($822,527).
A Randomized Recruitment Intervention Trial (RECRUIT)
Low minority participation in clinical trials limits our ability to assess and address potential differences in therapeutic responses. To address the problem of low minority recruitment we are testing a recruitment intervention (RECRUIT) to increase racial/ethnic diversity in clinical trials. Our specific approach is directed toward multisite trials conducted at specialty clinics in academic centers. The intervention will focus on approximately 60 specialty clinics. Clinical sites will be randomized to the intervention or control group. The target of the intervention will be the site principal investigators and trial coordinators. Sponsored by the National Institute on Minority Health and Health disparities (NIMHD); 2011-2016.
PROPPR is a multicenter, prospective, randomized trial which will compare different ratios of blood products given to trauma patients who are predicted to require massive transfusions (greater than 10 units of PRBCs within the first 24 hours).
This trial is sponsored by the Department of Defense and the National Heart Lung and Blood Institute. The Resuscitation Outcomes Consortium (ROC), led by Gerald Van Belle, PhD, MA, will work to provide coordination and oversight. PROPPR is a multicenter, prospective, randomized trial which will compare different ratios of blood products given to trauma patients who are predicted to require massive transfusions (greater than 10 units of PRBCs within the first 24 hours). The patients who have been predicted to require a massive transfusion will receive blood products based on a 1:1:1, 1:1:2 ratios. A total of 580 patients will be enrolled into this study from 12 participating site in the United States and Canada. In addition to evaluating the patient outcomes based on ratio of products, extensive lab analysis will be done to evaluate the influence of fluid resuscitation on traumatic induced coagulopathy.
The HCCC (Houston Clinical Coordinating Center) will be led by John Holcomb, M.D. His group will be responsible for the overall clinical coordination for this study. Dr. Barbara Tilley will lead the HDCC (Houston Data Coordinating Center). Dr. Tilley and her group will be responsible for the data coordination, maintenance, and analysis for this study.
Completed Projects
Post-Trial Follow-up
Active follow-up of ALLHAT participants ended on March 31, 2002 (February 15, 2000 for doxazosin participants), for an average follow-up of 4.9 years (3.2 years for doxazosin). To answer additional scientific questions, a post-trial follow-up of participants through 2006 is planned to obtain data on post-trial morbidity and mortality. The extended follow-up will be carried out passively using national databases available through the National Death Index (NDI), Social Security Administration (SSA), Centers for Medicare and Medicaid Services (CMS), Department of Veterans Affairs (DVA), and United States Renal Data System (USRDS). When completed, endpoint data will be available for between 9 and 10 years of total follow-up.
The overall research objective of this extended follow-up is to compare long-term effects of antihypertensive treatment with a thiazide-type diuretic, a CCB, an ACE-inhibitor, or an a-receptor blocker when each drug is used as initial treatment with step-up drugs added as needed and, for the lipid component, to assess long-term effects of pravastatin compared with usual care. To meet these objectives, we will evaluate whether new differences emerge for outcomes that were not statistically different, especially CVD and total mortality, and whether the differences observed during the trial continue.
The ALLHAT extension protocol was developed by the CTC and the NHLBI Project Office and approved by the ALLHAT Steering Committee.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI); 2002-2006
Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial
A practice-based randomized clinical trial of antihypertensive pharmacological treatment in more than 600 office-based practices and general medical and specialty clinics in the U.S., Puerto Rico, the Virgin Islands, and Canada. It had two components:
- An antihypertensive component, to determine whether newer antihypertensive agents, such as ACE inhibitors, calcium blockers, and alpha blockers, reduce incidence of coronary heart disease (CHD) in high-risk hypertensives when compared to diuretics.
- A lipid-lowering component, to determine whether reduction of serum cholesterol with pravastatin, an HMG-CoA reductase inhibitor, reduces total mortality in moderately hypercholesterolemic older hypertensives.
A total of 42,418 patients were enrolled between February 23, 1994 and January 31, 1998. A vanguard phase was conducted in the first half of 1994; the full-scale trial began in the fall of 1994 and continued for eight years, until March 31, 2002. The last participant visit was March 31, 2002. The results of the trial were released December 17, 2002.
ALLHAT continues to analyze data for presentations and publications on secondary outcomes, outcomes in subgroups, and other topics for both the antihypertensive component and the lipid-lowering component of the trial. There is also an ongoing Dissemination effort to reach physicians, patients, and formulary benefits managers with the core messages of ALLHAT and the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7).
Sponsored by the National Heart, Lung and Blood Institute (NHLBI); 1993-2008 ($101,198,107).
Genetics of Hypertension Associated Treatments (GENHAT)
A prospective study that examines the association between selected hypertensive genes and coronary heart diseases modified by the type of antihypertensive treatment. GENHAT is an ancillary study of ALLHAT.
Sponsored by the National Heart, Lung and Blood Institute (NHLBI); 1999-2004 ($1,474,101).
Early Treatment for Retinopathy of Prematurity (ETROP)
ETROP is a multicenter study in 26 centers with a natural history study that is determining the incidence of retinopathy of prematurity and a randomized clinical trial that is determining the safety and efficacy of early treatment of retinopathy of prematurity in 400 premature infants.
Sponsored by the National Eye Institute (NEI); 1999-2009 ($18,405,455). Publications (PDF)
Light Reduction in Prevention of Retinopathy of Prematurity (LIGHT-ROP)
A randomized, multicenter clinical trial in three centers that determined the efficacy of reduced ambient-light exposure to reduce the incidence of retinopathy of prematurity in 409 premature infants.
Sponsored by the National Eye Institute (NEI); 1995-2000 ($441,535). Publications (PDF)
Cryotherapy for Retinopathy of Prematurity Study (CRYO-ROP)
A randomized multicenter study in 23 centers enrolling 4,099 infants in a natural history study with a randomized clinical trial that determined the safety and efficacy of cryotherapy of the retina in the treatment of retinopathy of prematurity in 291 premature infants.
Sponsored by the National Eye Institute (NEI); 1985-2003 ($4,534,242). Publications (PDF)
Systolic Hypertension in the Elderly Program (SHEP)
A randomized, multicenter clinical trial in 16 centers which tested the effectiveness of antihypertensive treatment in reducing the combined incidence of fatal and nonfatal stroke in 4,736 elderly patients with isolated systolic hypertension.
Sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and National Institute on Aging (NIA); 1984-1993 ($9,003,630). Publications (PDF)
Survival and Ventricular Enlargement Study (SAVE)
A randomized, placebo-controlled, multicenter clinical trial in 40 centers that tested the effectiveness of captopril in reducing total mortality and/or ventricular enlargement in 2,231 post-myocardial infarction patients.
Sponsored by Bristol-Myers-Squibb, Inc.; 1986-1993 ($1,959,014). Publications (PDF)
Cholesterol and Recurrent Events Trial (CARE)
A randomized, placebo-controlled, multicenter clinical trial in 80 centers that tested the effectiveness of pravastatin in reducing cardiovascular events in 4,159 post-myocardial infarction patients.
Sponsored by Bristol-Myers-Squibb, Inc.; 1989-2002 ($4,319,394). Publications (PDF)
Beta-Blocker Heart Attack Trial (BHAT)
A randomized, double-blind, multicenter clinical trial designed to test the effectiveness of propranolol in reducing mortality in 3,837 post-myocardial infarction patients in 31 centers.
Sponsored by the National Heart, Lung, and Blood Institute (NHLBI); 1984-1993 ($4,208,443). Publications (PDF)
Hypertension Detection and Follow-up Program (HDFP)
A clinical trial in 14 centers which investigated the differences in mortality and selected morbidity between 10,940 patients randomly allocated to either an intensive hypertension control program or referral back to the regular medical care system.
Sponsored by the National Heart, Lung, and Blood Institute (NHLBI); 1971-1993 ($18,059,234). Publications (PDF)
Trial of Antihypertensive Interventions and Management (TAIM)
A three-center study of the effectiveness of dietary and pharmacological measures in treating 878 mild hypertensive patients.
Sponsored by the National Heart, Lung, and Blood Institute (NHLBI); 1984-1993 ($1,058,316). Publications (PDF)
Publications
ALLHAT Publication (ALLHAT.org)
Five University of Texas School of Public Health at Houston faculty members are co-authors of, Long-Term Follow-Up of Participants With Heart Failure in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) (PDF), which has just been published (Circulation (2011;124:1811-1818). This article reports results on long-term follow-up of heart failure patients in ALLHAT showing that once heart failure develops, the risk of death is high and measures to prevent its development, especially blood pressure control, must be a priority. The multicenter ALLHAT study is conducted under a National Institutes of Health contract with The University of Texas Health Science Center at Houston. The co-authors are faculty in the UTSPH Division of Biostatistics Coordinating Center for Clinical Trials. They are Linda B. Piller, MD. M.P.H., associate professor, Sarah Baraniuk, Ph.D., assistant professor, Lara M. Simpson, Ph.D., faculty associate, Charles E. Ford, Ph.D., associate professor, and Barry R. Davis, M.D., Ph.D., professor and director. Long-Term Follow-Up of Participants With Heart Failure in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
ALLHAT Press Release
Diuretics were associated with reduced heart disease in a drug comparison trial involving 23,077 people with both high blood pressure and the metabolic syndrome…
GenHAT Press Release
Genetic makeup may impact the effectiveness of medications for high blood pressure, which could help explain why certain drugs work for some people and not for others…
ALLHAT Press Release (NIH.gov)
“Landmark Hypertension Treatment Study Launches Extensive Physician and Patient Education Program to Improve Public Health” (from NIH/NHLBI). Researchers in the largest high blood pressure clinical trial ever conducted are launching a comprehensive outreach program to improve high blood pressure control nationwide…
ALLHAT Publication (ALLHAT.org)
Three University of Texas School of Public Health at Houston faculty members are co-authors of , “Outcomes in Hypertensive Black and Nonblack Patients Treated with Chlorthalidone, Amlodipine, and Lisinopril” (PDF), which has just been published (The Journal of the American Medical Association (2005;293:1595-1607). This article reports study results suggesting older, cheaper diuretics remain the drug of choice for both black and nonblack patients in treating high blood pressure and reducing risk of heart disease.
The multicenter ALLHAT study is conducted under a National Institutes of Health contract with The University of Texas Health Science Center at Houston. The co-authors are all faculty in the UTSPH Division of Biostatistics and the Coordinating Center for Clinical Trials. They are J. Kay Dunn, Ph.D., associate professor, Barry R. Davis, M.D., Ph.D., professor and director, and Charles E. Ford, Ph.D., associate professor.
CCCT Director Receives President’s Scholar Award
Barry R. Davis, M.D., Ph.D., professor and director of the Division of Biostatistics and director of the CCCT at the UT School of Public Health at Houston, received the 2004 President’s Scholar Award for research.
ALLHAT Publication (ALLHAT.org)
A new article, “ALLHAT: Setting the Record Straight,” has just been published (Annals of Internal Medicine (2004;141:39-46).
ALLHAT News (ALLHAT.org)
UTHSC-H Distinctions (May 2004) identifies the public information campaign that will use 200 clinician-educators to meet with physicians and professional organizations nationwide in Project Goes Door to Door publication (ALLHAT.org).
KUHF Houston Public Radio (April 6, 2004) reported on the campaign to inform physicians about the ALLHAT study and its recommendations in the Real Audio sound file, New Development publication (ALLHAT.org).
The Houston Chronicle (February 28, 2004) discusses an unprecedented initiative by NHLBI to disseminate ALLHAT study results in Fed Ads Touting Cheaper Drugs publication (ALLHAT.org).
ETROP Results Released!
Premature infants will retain better vision when therapy is administered in the early stage of the disease.
