Cotton-O'Neil Clinical Research Center
More than 4,000 people from Shawnee County and the surrounding area have participated in a study at the
Cotton-O’Neil Clinical Research Center. Learn how you can become a research volunteer.
To find currently enrolling research studies for a specific medical condition or other criteria, click here.
The mission of the Cotton-O’Neil Clinical Research Center is to contribute to the development of pharmaceutical products and devices and medical science through the quality performance of clinical trials and to improve the health of individuals in our local and global community.
- More than 20 research coordinators, many of whom are certified by the Association of Clinical Research Professionals (ACRP) and the Society of Certified Research Associates (SOCRA)
- Regulatory specialists, research phlebotomists, and administrative support staff
- 50 physician investigators (about 25 percent of the Stormont-Vail/Cotton-O’Neil Medical Staff)
- 150 currently-enrolling clinical studies in a variety of therapeutic areas
Our therapeutic areas:
ACS (Acute Coronary Syndrome), ADHD (Attention Deficit Hyperactivity Disorder), Adolescent Migraine, Allergies, Alzheimer’s Disease, Arthritis, Asthma, Bipolar Disorder, Cancer, C-Diff, CHF (Congestive Heart Failure), COPD (Chronic Obstructive Pulmonary Disorder), Crohn's Disease, Depression, Diverticulitis, Erectile Dysfunction (ED), Hepatitis, Hypercholesterolemia (High Cholesterol), Hypertension (High Blood Pressure), Intra-abdominal Infections, Irritable Bowel Syndrome, Obesity/Weight Loss, MI (Myocardial Infarction/Heart Attack), Pain Management, Psoriasis, Pediatric Vaccination, Proctitis, Pyelonephritis, Schizophrenia/Schizo-affective Disorder, Sepsis, Type I Diabetes, Type II Diabetes, Ulcerative Colitis
(Diseases and conditions in which we are or have been involved in research studies, for a complete list and for more detailed information call: (785) 270-8619.)
Participating Stormont-Vail HealthCare/Cotton-O’Neil Clinic Departments:
Allergy & Immunology, Behavioral Health, Cardiology, Diabetes & Endocrinology, Digestive Health, Women’s Health, Hospitalist Program, Internal Medicine, Neurology, Pediatrics, Pulmonology, and Surgery & Trauma Services
Clinical Research Center locations:
- Behavioral Health at Stormont-Vail West
- Cotton-O’Neil Cancer Center
- Central Clinical Research Center/823 SW Mulvane
- Cotton-O’Neil Diabetes & Endocrinology
- Cotton-O’Neil Digestive Health Center
Research sponsors with whom we’ve partnered:
Abbott, Abt Bio-Pharma, Alba, AGI, Astra Zeneca, Athlerys, Boehringer-Ingelheim, Bristol Myers-Squibb, Centocor, Cerimon, Cleveland Clinic, COSMOS, Eisai, Eli Lilly, Evoke, Fibrogen, Genentech, Glaxo Smith Kline, Increlex, Jazz, Johnson & Johnson, On-X, Medimmune, Medtronic, MedPace, Merck, Midwest Cancer Alliance, National Institutes of Health, Novartis, Novartis Vaccines, Novo Nordisk, Ortho McNeil, Orgenon, Osiris, Pfizer, Proctor & Gamble, Prometheus, Protein Design Labs, Reata, Roche, RPS, Sanofi Aventis, Salix, Schering Plough, TAP, Takeda, Tolerx, University of Kansas Medical Center, United BioSource, Wyeth, Yale Medical Center.
What is clinical research?
The Phases of Clinical Research:
- Pre-clinical - Animal and laboratory testing
- Investigational New Drug (IND) - Required application from a pharmaceutical company to the FDA to begin a clinical research study with a new product.
- Phase I - Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II - The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- Phase III - The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- Phase III - Further expands group of people to include drug to disease interactions and drug to drug interactions.
- New Drug Application (NDA) - Application to the FDA for marketing approval or license. This occurs after completion of Phase I, II, III to market the drug for specified indication.
- Phase IV – Post marketing studies to delineate additional information including drug’s risk, benefits, and optimal use.
*Source: National Institute of Health
What are the different types of clinical studies?
- Treatment trials - test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials - look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
- Diagnostic trials - are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials - test the best way to detect certain diseases or health conditions.
- Quality of Life trials (or Supportive Care trials) - explore ways to improve comfort and the quality of life for individuals with a chronic illness.
*Source: National Institute of Health
The Stormont-Vail HealthCare Human Research Protections Program serves to protect the rights and welfare of human research participants in accordance with:
- Clinical Research and the Protection of Human Research Participants
- U.S. Department of Health & Human Services
- The Common Rule
- Food & Drug Administration
- Code of Federal Regulations
- International Code of Harmonization
- Stormont-Vail HealthCare Institutional Review Board
- Centrally affiliated Institutional Review Boards
- Health Insurance Portability and Accountability Act (HIPAA)
- Joint Commission
- State of Kansas Laws
For additional information, please call: (785) 270-8619.