The Clinical Trials Research Alliance (CTRA) is a public-private initiative combining two of Dayton’s most trusted organizations, Wright State University and Premier Health, to conduct clinical trials in a variety of disciplines.
Wright State University brings the area’s strongest biomedical research institute, Wright State University Boonshoft School of Medicine. To the alliance, Premier Health adds the clinical resources of one of the region’s leading healthcare systems, including more than 100 locations throughout southwest Ohio.
As a relatively young trial center, the CTRA provides nimble, one-point-of-contact service for sponsors with a comprehensive, network-based solution. CTRA offers sponsors a compelling site management option.
The CTRA includes more than 80 investigators and is constantly growing. The investigators are experts in more than 40 therapeutic areas. Most have numerous years of experience in conducting trials, and all have been trained in Good Clinical Practice.
The alliance includes hospitals and major healthcare centers spanning roughly 1,500 square miles throughout Southwest Ohio. Counties with CTRA partner healthcare facilities and their 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 150,000 registered volunteers nationwide and almost 8,000 within an hour of CTRA facilities.
CTRA strives to offer local access to clinical trials, eliminating the more than one hour drive to the closest cities of Cincinnati, Columbus, and Indianapolis.
CTRA’s network of closely aligned healthcare facilities allows a clinician or team of clinicians to conduct trials at several sites, greatly expanding opportunities for patient participation.
Premier’s healthcare network includes include three hospitals; two comprehensive health care centers; Premier HealthNet, the area’s largest group of primary care practices; Premier Health Specialists, the region’s largest group of specialty care practices; outpatient surgery centers; after-hours care; community health clinics; long-term care facilities; and home health care services.
Wright State Physicians is one of the largest physician-managed multispecialty groups in the region. Its clinicians practice at Wright State Physicians Health Center and throughout the community. The Wright State Physicians Health Center on the Wright State University campus offers CompuNet Clinical Laboratories and WrightCare, a same-day medical care service.
Additional CTRA network resources include:
- Investigational pharmacist maintains a secure storage, dispensing, and accountability system with service available 24 hours per day
- Comprehensive laboratory services
- Robotic surgery systems, including da Vinci
- The region’s only Level 1 Trauma Center
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. CTRA works with Schulmann, WIRB, and the SMART IRB system.
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.
The CTRA’s operational support can accelerate all parts of the contracting and trial management process. This comprehensive assistance frees researchers from much of a trial’s administrative paperwork and bureaucracy, leaving them more time to do what they were trained to do as the clinical researcher conducting the trial.
- Business development, matching investigators to trial and research opportunities
- Compliance monitoring and quality assurance
- Ethics consultations
- Financial negotiation and budget management
- Regulatory and clinical operations management
- Electronic data management through a Clinical Trial Management System
- Contract negotiation
- Experienced clinical trial coordinators, all certified in Good Clinical Practices
- Patient recruitment management
- Clinician referrals
- ResearchMatch national clinical research participant registry
- CTRA’s website
- Promotional materials for Premier Health, Wright State Physicians and Boonshoft School of Medicine
- EHR access to determine patient population size by indication
- Research participant advocacy through the CTRA's Community Advisory Board
- Metrics and benchmarking data
- Study initiation averages tthree to five months
- Education and training in the ethical conduct of clinical trials for coordinators and investigators
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 University 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.
CTRA has successfully completed more than 50 trials for such leading sponsors and CROs as:
- Boehringer Ingelheim (BI)
- Cempra Pharmaceuticals
- Conceptus, Inc.
- Duke University
- Eli Lilly
- Gilead Sciences, Inc.
- Grifols Biologicals, Inc.
- Hansen Medican
- Inc. Research
- Johns Hopkins University
- McMaster University
- Morphotek, Inc.
- The National Institute of Neurological Disorders and Stroke (NINDS)
- Northwestern University
- St. Jude Medical
- Surefire Medical, Inc.