Clinical & Translational Research Home for Atlanta and Scientific Advances
Since 2007, this partnership has developed an Atlanta “home” for clinical and translational research and has directly supported or contributed to 673 investigators; over 520 clinical interaction site projects and 147 pilot projects in 96 research areas; 119 federal (PHS) grants; 134 current or graduated MSCR, KL or TL scholars and over 75 other active trainees. The direct support has also contributed to 661 scientific publications a tripling of inter-institutional collaborations, and important scientific breakthroughs in clinical and translational science. Approximately 25% of Emory Woodruff Health Sciences faculty, 40% of Morehouse School of Medicine faculty and a increasing number of biomedical Georgia Tech faculty have been directly supported.ACTSI’s direct support of breakthroughs in cutting-edge clinical and translational research:
- in transplantation - first human hand transplant in the Southeast and development of belatacept for prevention of rejection
- in neurosciences - the development of primate animal models for Huntington’s and Alzheimer’s disease, progesterone for neural injury, defining the biological basis of fear and post-traumatic stress disorder (PTSD), and first-in-human spinal stem cell infusions for amyotrophic lateral sclerosis (ALS)
- in infectious diseases - the rapid clinical evaluation of the H1N1 influenza vaccine and steps toward a universal influenza vaccine
- in endocrinology - defining immune approaches to therapy of type 1 diabetes
- in genetics - work toward therapies for fragile X syndrome
- in new models to address community engagement and health disparities
The Pilot Grants program has funded 147 grants thus far using $6 million in funding and 37 independent review cycles. The awards are divided between senior and junior PI investigators, and are distributed across all three ACTSI partner institutions, spanning a spectrum of translational research topics.
Clinical Research Sites
Clinical Research Network (CRN) protocols have almost tripled since 2007. The CRN continues to establish sites throughout Atlanta, currently totaling 35 – the newest sites include the Georgia Tech Research Institute, the Emory Clinical & Translational Research Laboratory, and the Emory Integrated Genomics Core. In addition, the CRN was integral in the development of the inter-institutional Research Nursing Alliance which is dedicated to sharing ideas to improve clinical research nursing practice. The CRN developed and hosts the annual Clinical Practice of Human Subjects in Research seminar open to clinical professionals from all ACTSI partner institutions. CR-Assist, the CRN/BIP developed, web-based participant scheduling and tracking system received national attention from the CTSA Consortium. The CRN also recently completed an agreement with Emory Medical Labs to provide limited after-hours processing and provides support for the Laboratory Management System (LIMS) at the Hope Clinic, Ponce Center, Executive Health Program, Children’s Healthcare of Atlanta at Egleston, the Winship Cancer Center Phase 1 Unit, and Morehouse School of Medicine. Collaboration with Winship Cancer Institute (WCI) has been strengthened by regular nursing support provided to the WCI Phase 1 Unit. CRN nurses also travel off-site to support more projects at the Emory Genetics Center and the Atlanta VA Medical Center. The CRN now offers expanded cardiovascular and exercise testing services at the Emory University Hospital site, including space for forearm vascular reactivity, exercise treadmills, pulmonary function testing, arterial infusion, and body composition using dual-energy x-ray absorptiometry (DEXA). Finally, the Recruitment Resource Core has been developed to assist investigators with participant recruitment.
Education & Training
ACTSI’s Research Education, Training & Career Development (RETCD) program received a four-year $700,000 Howard Hughes Medical Institute Med into Grad grant to support the development of a Certificate Program in Translational Research for PhD graduate students in the biomedical sciences and engineering programs. The program is 16 credits and includes trainees from Emory, Morehouse School of Medicine and Georgia Tech. Former KL2 scholars are coordinators for the monthly MSM/Emory MSCR Journal Club and teach a one-week Short Course in Clinical and Translational Research. Nearly 75% of the RETCD KL2 scholars have obtained NIH funding as a PI.
Biostatistics, Epidemiology & Research Design (BERD) and RETCD offer a short course in Biostatistics which provides an opportunity for clinical investigators, epidemiologists, applied statisticians and research assistants to update their knowledge of biomedical research statistical methods. BERD faculty members at Emory University also provide a course in Bioinformatics to MSCR program participants, as well as a monthly Bioinformatics Interest Group seminar series. At Morehouse School of Medicine, BERD faculty provide courses in advanced Biostatistics and Epidemiology, along with workshops on SAS programming for clinical investigators. BERD faculty have produced important statistical and software methodology developments based on collaborations spawned by connections with ACTSI investigators.
The Research Technologies program facilitated development of new cutting-edge cores and discovery initiatives, for example, the Center for System Imaging (CSI), Center for Health Discovery and Well Being, Emory Personalized Immunotherapy Center (EPIC), and the Emory Heath Innovation Program (HIP). Research Technologies also sponsors symposia which promotes clinical and translational research and provides funding for the development of new and cutting-edge technologies.
The Biomedical Informatics Program (BIP) supported the development and dissemination of new clinical and translational tools and technologies like the ACTSI website, the Analytic Information Warehouse (AIW) and Eureka! (a suite of tools for creation of clinical research data marts and implementation of clinical phenotype definitions), eBIRT (one stop virtual shop for research resources), LIMS, CR-Assist; and the interactive “Studio” for proposal, project and protocol development. Studio Consultations were developed in conjunction with BERD and CRN to ensure ACTSI investigators receive focused biostatistics and biomedical informatics support, technical input and professional advice as they begin a proposal or a project. Research Technologies and BIP launched the electronic Biomedical Interactive Resource Tool (eBIRT) to connect researchers to available technologies resources throughout Georgia.
Development of a new citywide infrastructure for expanded pediatric-focused clinical and translational research based on the strategic three academic institutional partnership. ACTSI efforts led to the creation of a new and innovative pediatric clinical and translational research home and a full engagement with Children’s Healthcare of Atlanta. In its most recent full year of operation, the ACTSI Pediatrics program supported 597 research visits at the Pediatric Clinical Research Site within Egleston Children’s Hospital, and 1,455 visits within the Emory Children’s Center. In conjunction with the CRN, the ACTSI is now able to support research activities at Hughes Spalding Children’s Hospital. The CRN and Pediatrics program are also working to increase support for outpatient protocols conducted at the Emory-Children’s Center.
The e-Healthy Strides diabetes self-management intervention demonstrated its efficacy in a partnership with the Big Bethel AME Church and is now offered to City of Atlanta employees. i-Adapt is testing another diabetes self-management intervention at West End Medical Center. EPICS (Educational Program to Increase Colorectal Cancer Screening) offers instructions and materials on the National Cancer Institute’s RTIPs website and is being disseminated nationally through community coalitions. Four small grants were awarded to community organizations. The joint (MSM/Emory) Community Engagement and Health Disparities in Clinical and Translational Research course is in its second year. Finally, Community Health Matters is a new newsletter developed in collaboration with CERP and the CRN and is distributed to the communities served by the ACTSI.
Ethics & Regulatory
Enhancement of clinical research efficiencies by Atlanta-wide institutional agreements (e.g. IRB reciprocity and IP and Data Use agreements) and leadership of a comprehensive clinical trials improvement task force, the Healthcare Innovation Program (HIP), and Office of Clinical Research. Ethics & Regulatory's Online Ethics Center now includes over 40 ethical dilemmas in scientific research and expert opinions. The program also convened IRB officials from seven Atlanta research institutions in a first-of-its-kind meeting and co-created a cross institutional Electronic Conflict of Interest System (eCOI). Finally, IRB reciprocity and collaboration is improving throughout Atlanta – formal IRB reciprocity agreements now exist between all ACTSI partners.
Creation of activities, such as the Academic & Industry annual forum and device-focused pilot projects, that build strong partnerships with the private non-profit Georgia Bio (encompassing the Georgia biotechnology community), the Coulter Foundation, and the state-sponsored Georgia Research Alliance to create synergies that foster and accelerate new and emerging technologies and discoveries.
Expansion of existing synergistic partnership with Yerkes National Primate Research Center on informatics, animal models, and educational opportunities.
Development of a growing partnership with the Winship Cancer Center, a newly designated NCI Cancer Center, and collaborative efforts with Winship in genomics, a phase I clinical trials unit, joint pilot grants, and synergy with the Georgia Cancer Coalition and the Atlanta headquartered American Cancer Society.
Development of healthcare partnerships with the largest healthcare networks in Georgia including - Emory Healthcare, Children’s Healthcare of Atlanta, Morehouse Medical Associates, Grady Health System, Kaiser Permanente of Georgia, Saint Joseph’s Hospital and Veterans Affairs Medical Center of Atlanta.