Clinical Research Program
The Clinical Research Program was established in 2008 for the purpose of patient care support through availability of clinical trials in the Kansas City metropolitan area. Clinical trials are conducted by well-trained institutional affiliated researchers. The Clinical Research Program is owned and operated by HCA Midwest Health System. The program provides exceptional service at Belton Regional Medical Center, Centerpoint Medical Center, Lee's Summit Medical Center, Menorah Medical Center, Overland Park Regional Medical Center, and Research Medical Center.
The clinical research studies, conducted by the principal investigator, are reviewed by the HCA Midwest Health System's Institutional Review Board (IRB)and guided by the ethical principles for all research involving humans as subjects and abides by:
- The Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,
- Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, and
- The Common Rules 45 CFR 46 and 21 CFR 56
The Clinical Research Program includes 5 full-time coordinators who specialize in Oncology, Cardiology and Neuroscience therapeutic lines. A full-time regulatory specialist and a full-time financial specialist are able to support the administration of this program. Each individual within the program bring specialized expertise to the table which in turn makes this program outstanding.
The Clinical Research Program supports overall patient care by offering another therapeutic option through clinical trials. These are available through the Kansas City Clinical Oncology Program (KCCOP), Sarah Cannon Research Institute, and various pharmaceutical and CRO partners.
For a complete list of open Studies:
Information for Sponsor
- NCI affiliated hospital with capacity of in/ out patient protocol setting
- Trained pharmacist for drug accountability
- Board certified medical oncologists
- Board certified radiation oncologists
- Accredited Comprehensive Cancer Center through ACoS
- Accredited Breast Cancer Center through NAPBC
- Level I Trauma and Stroke Designation through TJC
- Accredited Cardiology Center
- Archiving / storage capacity for source documentation
- eMAR system for medical record and easy audit review.
- Local IRB for initial submission, continuing review, and protocol amendments.
- Capacity to incorporate study specific needs (i.e. special inspection/ equipment/ resources)
Frequently Asked Questions
Please refer to http://clinicaltrials.gov for detail understanding and FAQ regarding taking part in the Clinical Research.
Clinical Research Study Start Up Process
Institutional Review Board
The Clinical Research Program has access to the local Institutional Review Board (IRB). For initial and continuing review, the IRB meets and reviews protocols every third Wednesday of the month. Deadlines for submissions are within 2 weeks of IRB meeting. The IRB review is able to run concurrently with budget/contract negotiations on new protocols. There is a one-time, non-refundable fee and paid as a pass-through within the study budget.
Our office has a dedicated full time Regulatory Specialist with access to electronic IRB submission. The turn-around time for most regulatory documents in the study start up is 4-6 weeks.
The budget and contract negotiation occurs concurrently with regulatory documents and IRB submission. There is a dedicated Financial Specialist for point of contact from study initiation through to contract execution. The turn-around time for budget/contracts is approximately 6 weeks or less.
Clinical Research Staff Members
The Clinical Research Staff consists of the following disciplines:
- Hematology/ Oncologist
- Radiation Oncologist
External Resources for Clinical Trials
Office of Human Research Protection(OHRP)
Food and Drug Administration (FDA)
- Human Subjects Protections (Informed Consent) and Additional Safeguards for Children in Clinical Investigations
- 21CFR Part 56 Institutional Review Boards
- 21 CFR Part 312 Investigational New Drug Application (INDs)
- 21CFR Part 812 Investigational Device Exemptions (IDE)
Jennifer W. Feeback
Clinical Research Manager
6420 Prospect Ave, Ste T211,
Kansas City, MO 64132