LGBT Cancer Project

Wright State University and Premier Health Clinical Trials Research Alliance

Center Information

Loren Friedman
Director of Clinical Trials, Business/Investigator Development
Wright State University and Premier Health Clinical Trials Research Alliance
4035 Colonel Glenn Hwy.
Dayton, OH 45431
USA
937-705-1083
937-705-1095 (fax)
ctra@wright.edu
www.clinicaltrialsresearchalliance.com
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Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Healthy Volunteers
Hematology
Hepatology (Liver, Pancreatic, Gall Bladder)
Immunology
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Oncology
Ophthalmology
Orthopedics/Orthopedic Surgery
Pediatrics/Neonatology
Pharmacology/Toxicology
Plastic Surgery
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Sleep
Trauma (Emergency, Injury, Surgery)
Urology

Center Overview

The Wright State University and Premier Health Clinical Trials Research Alliance (CTRA) offers nimble, one-point-of-contact service for sponsors and a comprehensive, network-based solution.

CTRA is a public-private initiative combining the Dayton region’s strongest biomedical research institution-Boonshoft School of Medicine- with the clinical resources of Premier Health, one of the largest health systems spanning Southwest Ohio, and Wright State Physicians, a consortium of more than 150 doctors practicing in a wide range of specialties.

CTRA supports trials throughout the network of sites with comprehensive clinical trial assistance and infrastructure. Sponsors can easily leverage any or all of the organizations in the network, providing trial uniformity over a large and diverse population with the need for only one IRB.

The CTRA also:

  • collaborates with community-based physician practices in a variety of disciplines and locations
  • supports multi-center trials and investigator-initiated studies both for drug development and devices
  • provides educational programs for investigators and the research community
  • promotes translational medicine, enabling clinicians and scientists from Wright State University, Wright State Research Institute and Centers of Excellence partners to move research discoveries from bench to bedside

Clinical Research Experience

CTRA has conducted more than 50 clinical trials in a variety of disciplines for companies such as Pfizer, St. Jude Medical, Lilly, Abbott, Sanofi and Gilead.

For industry-sponsored trials, CTRA benefits from access to a variety of IRBs, all of which are certified by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). These commercial IRBs meet frequently, providing a thorough and timely IRB review. In addition, Wright State University IRB is available to review non-industry sponsored clinical research. The use of commercial boards, as well as direct access to a local IRB, ensures a careful evaluation by reviewers with the appropriate expertise.

CTRA offers a suite of services to ensure trials are conducted with a focus on producing quality data safely, according to industry timelines, and with the highest level of ethical standards.

Support includes:

  • Business development, matching more than 100 investigators to trial and research opportunities
  • Compliance monitoring and quality assurance
  • Ethics consultations
  • Financial negotiations and budget management
  • Regulatory and clinical operations management
  • Electronic Data management through a Clinical Trial Management System
  • Contract Negotiation
  • Biostatisticians
  • More than 15 experienced clinical trial coordinators, all certified in Good Clinical Practices
  • Patient recruitment management
    • Clinician referrals
    • ResearchMatch national clinical research participant registry
    • CTRA’s Website and Facebook page
    • Promotional materials for Premier Health, Wright State Physicians, and Boonshoft School of Medicine
    • Patient EHR access to determine patient population size by indication
    • Regional advertising
  • Research participant advocacy through the CTRA’s Community Advisory Board of local patient support organizations
  • Metrics and benchmarking data
    • Study initiation averages 30-45 working days
  • Education and training in the ethical conduct of clinical trials for coordinators and investigators
  • Quality Assurance: As part of the CTRA Compliance Program, a Quality Assurance/Quality Improvement team conducts GCP/regulatory reviews on a routine basis. This includes review of regulatory documents; research records, including source docs; and subject billing records. The Quality Assurance team consists of members from Compliance & Regulatory Affairs from both the Wright State Research Institute and Premier Health. Findings are reported back to the Principal Investigator and research team, and the IRB of record, when appropriate. Findings are also utilized to educate and train research team members on regulation and policy

The Clinical Trials Research Alliance currently collaborates with investigators in the following disciplines:

  • Cardiology/Vascular Diseases
  • Dermatology
  • Devices
  • Endocrinology
  • Family Medicine
  • Gastroenterology
  • Healthy Volunteers
  • Hematology
  • Hepatology (Liver, Pancreatic, Gall Bladder)
  • Immunology
  • Infections and Infectious Diseases
  • Internal Medicine
  • Masculoskeletal
  • Neurology
  • Nutrition and Weight Loss
  • Obstetrics/Gynecology (Women’s Health)
  • Oncology
  • Orthopedics/Orthopedic Surgery
  • Pediatrics/Neonatology
  • Pharmacology/Toxicology
  • Plastic Surgery
  • Psychiatry/Psychology
  • Pulmonary/Respiratory Diseases
  • Rheumatology
  • Sleep
  • Trauma (Emergency, Injury, Surgery)
  • Vaccines
  • Facility Description

    The Clinical Trials Research Alliance (CTRA) collaborates with investigators to conduct clinical trials in the inpatient and outpatient facilities of Premier's network of more than 100 locations throughout southwest Ohio, in addition to Wright State Physicians medical center and community physicians.

    The CTRA’s major facilities include:

    • Good Samaritan Hospital is a full-service, acute-care hospital on the west side of Dayton, Ohio. The hospital has 3,300 employees and 577 beds. The Dayton Heart and Vascular Hospital is owned by Good Samaritan Hospital and is located on the hospital’s main campus
    • Miami Valley Hospital has 7,370 employees, 848 beds, an emergency and trauma center that is the busiest in Ohio, and three air ambulances known as CareFlight
    • Atrium Medical Center is a general medical and surgical hospital in Middletown, Ohio, with 314 beds serving the southernmost part of Southwest Ohio, including the greater Cincinnati area
    • Upper Valley Medical Center serves the communities of the Upper Miami Valley region in Southwest Ohio
    • Miami Valley Hospital South is a 579,000-square-foot complex on a 115-acre campus in Centerville, Ohio. It has 60 beds and features a number of specialty care options including oncology, cardiology, sports medicine, and maternity care to cater to the suburban community surrounding the hospital
    • Good Samaritan North Health Center, located in Englewood, Ohio, is one of the nation’s largest freestanding outpatient facilities, with more than 140 physicians practicing in a variety of medical specialties
    • Wright State Physicians is a group of 150 family and specialty physicians with offices throughout the Dayton region and at a Health Center on the campus of Wright State University. The Health Center offers a pharmacy, medical imaging, and clinical laboratories, as well as WrightCare same-day medical care for patients who do not need a hospital-based emergency department
    • Premier Health Specialists is the largest group of specialty care physicians in the Miami Valley with more than 111 physicians located at 79 centers throughout Greater Dayton
    • Ohio Eyecare Institute’s four physicians offer a wide range of eye care services including routine eye exams to cutting-edge eye and cosmetic surgery through four offices in the Greater Dayton region
    • Fidelity Health Care provides a wide variety of home health care services as well as medical equipment supplies to the residents of 17 counties in Southwest Ohio
    • Premier Community Health is uniquely designed to promote healthy living through prevention, early detection and disease self-management by offering health screenings, employee health management, and health services such as employer-based flu shots, smoking cessation support, and health education

    The CTRA also collaborates with:

    • Dayton Veteran’s Affairs Center
    • Dayton Children’s Hospital
    • Wright Patterson Air Force Base Medical Center
    • Wright Patterson Air Force Base Research Laboratory

    Staff Expertise

    Wright State University & Premier Health Clinical Trials Research Alliance has a centralized management administration overseeing its network of sites.

    4035 Colonel Glenn Hwy.
    Dayton, Ohio 45431
    937-705-1081
    937-705-1095 (fax)
    ctra@wright.edu
    clinicaltrialsresearchalliance.com

    Arthur S. Pickoff, M.D.

    Medical Director
    Founder and responsible for the overall direction of the Clinical Trials Research Alliance
    Phone: 937-705-1081
    Email: arthur.pickoff@wright.edu

    Mark Wysong, M.B.A.

    Director of Operations
    Founder and responsible for all operational aspects of the Clinicial Trials
    Research Alliance
    Phone: 937-705-1081
    Email: mark.wysong@wright.edu

    Loren Friedman, M.S.

    Director of Clinical Trials
    Responsible for the development and integration of clincial trials across Wright State University, Premier Health, and community affiliates
    Phone: 513-300-5533
    Email: loren.friedman@wright.edu

    Beth Burnside, M.A., CCRP

    Clinical Research Manager
    Oversees the start-up and execution of all CTRA clinical trials by collaborating closely with investigators, research coordinators, sponsors, and Contract Research Organizations
    Phone: 937-208-4469
    Email: baburnside@premierhealth.com

    Julie Carstens, M.P.A.

    Director of Compliance
    Responsible for the CTRA Compliance Program, including developing Standard Operating Procedures, providing training and educational opportunities, and managing the financial disclosure process
    Phone: 937-705-1023
    Email: julie.carstens@wright.edu

    Rachel Smith, M.Ed.

    Regulatory Specialist
    The primary point of contact with the Institutional Review Boards, investigators, research staff, and industry sponsors with regard to execution, approval, and maintenance of regulatory documents
    Phone: 937-705-1022
    Email: rachel.smith@wright.edu

    Chelsea Hurley

    Regulatory Support Specialist
    Responsible for maintenance of sponsor regulatory documents, collaborative electronic documentation, and Institutional Review Board (IRB) submissions
    Phone: 937-705-1022
    Email: chelsea.hurley@wright.edu

    Diane Mehling, RN, CCRC

    Certified Clinical Research Coordinator (CCRC)
    Negotiates all clinical trial budgets for CTRA with sponsors
    Phone: 937-306-1974
    Email: diane.mehling@wright.edu

    Danielle Booth

    Financial Manager
    Tracks sponsor payment and invoices, makes payments to sites and investigators, and manages internal CTRA financials and budget
    Phone: 937-705-1057
    Email: danielle.booth@wright.edu

    Kelly Stone

    Communications and Community Outreach Consultant
    Coordinates CTRA’s corporate communications to increase awareness of the benefits of clinical trials for patients in Southwest Ohio and of CTRA’s capabilities to clinician, investigator, and sponsor audiences
    Phone: 937-902-3133
    Email: kelly.stone@wright.edu

    Patient Demographics

    CTRA includes hospitals and major healthcare centers spanning roughly 1,500 square miles throughout Southwest Ohio. Counties with CTRA partner healthcare facilities and adjacent counties total a population of 2.8 million potential participants.

    Between Premier Health and Wright State Physicians, more than half a million patients are seen annually. In addition, the CTRA is a partner of ResearchMatch, providing access to more than 75,000 registered volunteers nationwide and more than 8,000 within an hour of CTRA healthcare facilities. The CTRA strives to offer local access to trials, eliminating the more than one-hour drive to the closest cities of Cincinnati, Columbus, and Indianapolis.

    Southwest Ohio demographic and health statistics indicate a region with greater than average socioeconomic and health issues.

    • Median Annual Income: $42,280 which is 10% below Ohio’s median annual income of $46,696 and 21% below the US median annual income
    • Air Pollution: Of the 10 counties graded by the American Lung Association for air pollution, 7 received a failing grade
    • Cardiovascular Disease: The 13 counties in which CTRA operates have a heart disease death rate of 209.04 per 100,000, which is higher than both the Ohio average (205) and the US average (196)
    • Diabetes: Of the 13 counties in the region where CTRA operates, 8 of the counties have higher than the Ohio average incidence rates of diabetes, with 2 counties in the highest category of rates between 11.4% and 13.5% incident rates
    • Cancer: In 2013, the combined incidences of cancer from these 13 counties totaled 13,940 new cases. Average annual number of new invasive cancer cases include: 1,372 colon and rectum; 2,255 lung; 1,978 breast; and 1,928 prostate
    • Infant Mortality: Of the 13 counties in the region where CTRA operates, 8 have rates higher than the Ohio average rate for infant mortality

    Other Information

    CTRA supports integrating multiple disciplines across the full translational science spectrum: from population-based and policy research, to basic discovery, and through patient-oriented clinical research. Supporting T1 through T4 research ensures that health needs are driving basic science and clinical research and enables new therapies to reach the public more effectively.

    The CTRA taps the wealth of basic research being conducted within Wright State University, including the Boonshoft School of Medicine, Centers of Excellence, and the Wright State Research Institute.

    Wright State University: A Carnegie-classified research university, Wright State is home to nearly 18,000 undergraduate and graduate students and saw more than $90 million in research awards in 2013

    Wright State University Boonshoft School of Medicine: includes basic science departments located on the Wright State University campus and clinical departments based throughout the community

    Wright State University Centers of Excellence

    • The Lifespan Health Research Center draws on the strength of the Fels Longitudinal Study, the world’s largest and longest running study of human development, growth, body composition, and aging, and other population-based studies past and present
    • The Wright State University & Premier Health Partners Neuroscience Institute speeds the transfer of research discoveries from the laboratory to the bedside, improving the diagnosis and treatment of neurological disorders
    • With medicine as its core component, the National Center for Medical Readiness at Calamityville is a one-of-a-kind training facility for medical, public health, public safety, and civilian and military disaster-response decision makers from around the world
    • The vision of the Ohio Center of Excellence in Knowledge-Enabled Computing (Kno.e.sis) is to move from computing focused on data or information processing to productive thinking and decision making that reflect the quality of human experience and effectiveness
    • The Center for Genomics Research’s primary mission is to provide support and core facilities for Wright State research faculty engaged in basic and clinical research in the areas of gene expression, flow cytometry, and genotyping
    • The Center for Global Health’s goals are to improve the quality, efficiency, and access to health care by serving the local community and developing national models
    • The Center for Interventions, Treatment and Addictions Research (CITAR), is the focal point for substance-abuse related services, academic research, and services research to advance the production, dissemination, and utilization of scientific knowledge and professional technology regarding the epidemiology, consequences, prevention, and treatment of substance abuse

    Wright State Research Institute: a highly regarded, fundamentally collaborative department of Wright State University that works with government, industry, medicine, and more to deliver solutions to strategic problems in Aerospace Research and Technology, Neuroscience and Medical Imaging, Human Factors and Industrial Systems, and Modeling and Simulation.

    Wright State Research Institute Community Collaborations

    • Neuroscience and Medical Imaging (NMI): improve warfighter assessment, modeling, and performance enhancement capabilities using advanced biomedical imaging and brain mapping techniques coupled with emerging cognitive augmentation strategies
    • Analyst Test Bed (ATB): test innovative Processing, Exploitation, and Dissemination (PED) technologies and capabilities within a realistic, multi-intelligence analyst environment that is optimized to deliver to the analyst the most information with the least possible workload
    • Remotely Piloted Aircraft (RPA): conceive, identify, research, develop, quantify, evaluate, demonstrate, and support the transition of single RPA operator/supervisor human performance enhancements to the Air Force operational user community
    • Aerospace Technology Evaluation and Assessment (ATEA): provide research and engineering for new air vehicle technologies and modeling and analysis and evaluation of current and future warfighter needs
    • Wright Brothers Institute (WBI): Tec^Edge initiative accelerates innovation capability through its offerings of development workshops, solution forums, and long-term resident team support. Tec^Edge Works provides a flexible environment for hands-on rapid prototyping and experimentation by government, university, and industry collaborators
    • AHEAD: The Alliance for Human Effectiveness and Advancement: supports research, development, test and evaluation, and transition of technology to unleash the human performance of the warfighter

    Contact Center

    If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.