The UNM Statistics and Data Coordinating Center (SDCC) collaborates with researchers to provide comprehensive scientific expertise in the design, implementation, management, and analysis of multicenter clinical trials. We work closely with the trial PI(s), Co-investigators, Sponsors, and the UNM Clinical and Translational Science Center (CTSC) to ensure high quality research.
Executive Director: Kimberly Page
Our team includes experienced project managers for study coordination and management. We provide expertise and guidance in protocol development and data use agreements, conforming to IRB regulations, developing standard operating procedures, and study documentation, site management, and study monitoring.
In collaboration with the CTSC, the SDCC provides an electronic data capture system for accurate data collection and secure storage of all study data. Our team designs the database, conducts database maintenance, performs data integrity checks and produces, weekly accrual reports, and other pre-specified and ad hoc reports, as requested.
The SDCC includes faculty biostatisticians and analysts who provide statistical analyses of the final study results and contribute to the final clinical study report(s). Our team participates in study design, creates central randomization algorithms, provides power calculations and study analyses, and contributes to manuscript writing and data dissemination.
The SDCC collaborates with investigators across the country to design and coordinate multicenter clinical trials. Our current studies include:
The HERO (Hepatitis C Real Options) study is a two-arm study evaluating modified directly observed therapy (mDOT) versus patient navigation (PN) to deliver HCV treatment to people who inject drugs. Patients receive treatment in two clinical health settings: (1) opioid treatment program (OTP) or (2) community-based health service (CBHS).
This is a multi-site study, with eight sites across the country and is currently in year five of six. All participants are either in follow-up or have completed the study. Participants were randomized to one of two treatment model arms, (1): modified directly observed treatment (mDOT) or (2): peer navigation (PN), at one of two clinical sites. The study enrolled 755 participants, with 621 initiating treatment. The primary endpoint occurs twelve weeks after treatment completion to determine Sustained Virologic Response (SVR). Additional outcomes include long-term SVR and reinfection.
This study is funded by PCORI, under principal investigator Dr. Alain Litwin of Clemson University and the Greenville Health System.
The CLARO (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses) study is a pragmatic, randomized controlled trial in eleven diverse primary care sites in New Mexico. The study will evaluate whether primary care patients with opioid use disorder (OUD) and co-occurring disorders (COD) (depressive disorders and/or PTSD) have increased access to medications for OUD, improved quality of care for OUD, depression and/or PTSD, and better patient-reported outcomes with the collaborative care model (CC-COD) as compared with enhanced usual care (EUC). We will recruit and randomize 900 individuals with COD to receive either CC-COD or EUC. Enrollment is expected to begin in November 2020.
The National Institute of Mental Health (NIMH) has funded this study through the Helping to End Addiction Long-term (HEAL) Initiative. The study is a collaboration between RAND, UNM Health Sciences Center, and the following clinical service provider organizations: Southeast Heights Clinic at University of New Mexico (UNM), First Choice Community Healthcare, and Hidalgo Medical Services.
This study is funded by NIMH under principal investigators Dr. Katherine E. Watkins (RAND) and Dr. Miriam Komaromy (Boston Medical Center).
The CODE (A population-based study on Clinical Outcomes of DolutEgravir among ART-recipients in Brazil) study is a prospective observational study to assess the outcomes of persons with HIV who start, or switch to, the antiretroviral therapy (ART) Dolutegravir (three arms), plus a control arm for persons who take a different ART. The primary outcome measure is the rate of treatment discontinuation at 12, 24, and 36 months. This study is expected to start enrolling in Q3 of 2020. This is a collaboration with the Universidade Federal da Bahia, ViiV, and nine other clinical sites. UNM is the Statistics and Data Coordinating Center for this three-year study.
This U01 (Collaborative Care teams for hospitalized patients with opioid use disorders: Translating evidence into practice) was funded by the National Center for Advancing Translational Science (NCATS) in June 2020. This study is a mixed methods, multi-site, randomized pragmatic trial that will evaluate whether an interdisciplinary, collaborative care team (CCT) increases the use of medication for OUD, and results in successful linkage to outpatient substance use treatment, for hospitalized patients with opioid use disorders (OUDs). It will also gather information on implementation, including assessing contextual factors, sustainability, and costs. This study has not yet started enrolling. The principal investigators are Dr. Itai Danovitch (Cedars-Sinai) and Dr. Katherine Watkins (RAND).
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