Clinical Trials Participation
We are pleased you want to learn about the work we do to benefit patients and practitioners in all areas of medicine. We look forward to providing the best service for our participants, referring providers and sponsors.
Clinical trials are performed to test the safety and efficacy for investigational medications. All investigational medications must prove they are safe in the laboratory before being used on humans. Clinical trials are monitored by Institutional Review Boards (IRB) to protect the safety of all participants. The Center for Clinical Research currently does outpatient trials only.
Participating in research is different from getting standard medical care. The main purpose of research is to create new knowledge for the benefit of future patients and society in general. Research studies may or may not benefit the people who participate. Research is voluntary, and participants may change their mind at any time. There is no penalty if participants decide not to participate, or if they start the study and decide to stop early. Either way, it will not affect medical care or services provided to the participants. Some studies offer participant payments to help cover travel expenses. The payments are issued on a ClinCard. A ClinCard is similar to a debit card.
The Center for Clinical Research conducts research studies in a variety of populations including children, adolescents, adults and geriatrics. These studies may include observation, psychotherapy, medications, antibodies and other biological therapies or devices with the focus of improving the fundamental understanding of the cause of medical disorders.
The Center for Clinical Research is overseen by the director, Tiffany Schwasinger-Schmidt, M.D., Ph.D. Dr. Schwasinger-Schmidt has been participating in clinical trials since 2017 and has been investigator on more than 30 trials. The research staff consists of research nurses, study coordinators, and recruiters who are extensively trained in running clinical trials.
The equipment available through the Center for Clinical Research includes a 4 degrees Celsius refrigerator, -20 degrees Celsius freezer, -80 degrees Celsius freezer, IP storage, all temperature monitored as well as refrigerated and ambient centrifuges. The research staff can perform procedures such as PK testing, intravenous infusions, pharmacogenomics, ECG, standardized ratings and phlebotomy for sample collection.
Through the work of the Center for Clinical Research, we are able to bring cutting edge care to Kansans by studying the effects of new medications and devices to determine safety and effectiveness in treatment. At the KU Center for Clinical Research, we are advancing the practice of medicine right here in Wichita.
The Center for Clinical Research is always looking for investigators to join the team. As an investigator your responsibilities will include conducting the study in accordance with the protocol. You will participate in the subject's study experience including consenting the subject to personally conducting study procedures. You will also ensure that all associates and employees assisting in the conduct of the study are informed about their obligation in meeting the commitments of the protocol. You will be responsible for maintaining adequate and accurate records and make those records available for inspection. You will promptly report to the IRB and study sponsors all changes in the research activity and any unanticipated problems involving risks to the subjects or others. If the study includes an investigational drug, you are responsible for reading and understanding the information in the investigator's brochures including the potential risks and side effects of the drug and inform subjects that the drugs are being used for investigational purposes. Please refer to Code of Federal Regulations (21 CFR Part 312 Section 312.60) for further responsibilities of investigators.
Students will develop an appreciation for the practical challenges inherent in clinical research including balancing scientific and ethical responsibilities, subject recruitment and obtaining funding. They will also be introduced to ethical issues including human subjects protections and Institutional Review Board requirements in clinical research. During a rotation with the Center for Clinical Research students will be exposed to research instruments and rating scales. They will begin to understand specific study designs and how they lend themselves to answering specific research questions. In addition, knowledge of the drug development process will help future practitioners improve their patient care because it helps them understand how drugs come to the market and what process goes into generating data published in the literature.