Clinical research is research that occurs in humans. Before testing can begin in humans, extensive pre-clinical or laboratory research must be conducted in animal and human cells. Studies later proceed to extensive animal testing. This process may take years of experiments. If the testing in animals proves successful and promising, the sponsor must request the opportunity to present the basic research study results to the Food and Drug Administration (FDA) and seek FDA approval to begin clinical testing.
A clinical study is a research study designed to answer specific questions about drugs/vaccines or new therapies or new ways of using known treatments. Clinical studies (also called clinical trials) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical studies are the fastest and safest way to find treatments that work.
The Avera Research Institute is conducting multiple industry sponsored Phase II, III, and IV clinical drug trials involving a wide range of therapeutic areas and both inpatients and outpatients. These studies test new drugs or medical devices to evaluate their safety and efficacy both prior to and after approval by the Food and Drug Administration.
Learn more about Clinical Research Trials.
Gulf War Illness Research
In 1999, Congress authorized and appropriated to the Department of Defense $6 million for research on Gulf War veterans’ illnesses. The intent of Congress was that these funds should go to continue to support research at Georgetown University on the pathophysiology of chronic multisymptom illnesses (CMI). In addition, there was an understanding that these funds would be used to open up channels of communication and collaboration between Georgetown University and the biomedical research community of the Department of Defense to facilitate the translation of research findings from the laboratory to use in diffuse health care settings.
Research leaders at Georgetown University determined that their objectives could be best met by collaborating with the Avera Research Institute at Avera McKennan Hospital to develop a system to support and facilitate multi-site clinical research. This system will include an infrastructure to provide “treatment-at-a-distance,” defined as a therapeutic intervention that might involve a clinician at Avera McKennan directly interacting with a research subject at a remote site. Such interventions may involve psychotherapeutic modalities that use forms of rapid communication such as the internet or high-speed audio/video connections. The development of this model will serve as a “turnkey” clinical research system that can be easily transferred to the Department of Defense healthcare systems and ultimately to a wider base of healthcare systems.
This Principal Investigator and research staff relocated to the University of Michigan effective April 1, 2002.
The system will be applied to clinical trials of treatment methodologies for chronic multi-syndrome illnesses (CMI) including persons with Chronic Fatigue Syndrome (CFS), Fibromyalgia Syndrome (FMS), and Gulf War veterans’ illnesses (GWVI). The first clinical research study will combine the efforts the University of Michigan Chronic Pain and Fatigue Research Center with the efforts of the Avera Research Institute in chronic, non-malignant, musculoskeletal pain management. This study will evaluate the health and economic benefits of adding cognitive and behavior therapy (CBT) delivered by an internet website to standard medical care for fibromyalgia.
Congestive Heart Failure Research Study
In October of 2000, Avera McKennan submitted an application to the Health Care Financing Administration (HCFA) for a Medicare Demonstration Project to test the cost-effectiveness of Medicare paying for case management services in chronic diseases that represent high costs to the Medicare program. The chronic disease that Avera McKennan selected was Congestive Heart Failure. In February of 2001, the Avera Research Institute received notice that Avera McKennan was one of sixteen sites selected in the United States (of which 4 were rural) to participate in this demonstration project.
This four year research study will involve 700 subjects who are 65 years and older and who have been diagnosed with congestive heart failure (CHF). The study is designed to demonstrate the positive benefits of a coordinated care management model in a rural setting. The CHF care coordination team utilizes a multidisciplinary approach that includes physicians, registered nurses, pharmacists, dieticians, cardiac specialists, home health specialists, psychotherapists, and social services workers.
This study utilizes a home monitoring system. The system is comprised of two main components: the patient module and the central monitoring station. The patient module collects real clinical data, including weight, heart rate, non-invasive blood pressure, oxygen saturation and if necessary, temperature. The patient module is simple to use, requiring only a few key presses, and takes approximately 3 minutes to complete. The custom designed blood pressure cuff can be easily positioned with one hand. The finger probe non-invasively measures heart rate and oxygen saturation. The digital scale, which is accurate to within 1/10th of a pound, measures the patient’s weight for early detection of fluid build-up. Temperature, if needed, is measured in 5 seconds with a digital thermometer.
At a predetermined time each day, through a user-friendly voice prompt, the monitor instructs the patient that it is time to measure vital signs. The monitor continues to prompt the patient through the process of obtaining the vital signs. After the last of the vital signs is taken, the patient is asked up to ten subjective yes/no questions. These answers further assist the clinician in evaluating the condition of the patient by providing a more comprehensive assessment. Once the questions are answered, the monitor’s voice prompt reminds the patient to take medications as ordered and to follow the prescribed diet. The home monitor then automatically transmits the patient data to the central monitoring station. The home monitor is equipped with dual communication modes, digital wireless pager or modem via the home telephone line, for those patients who are not within wireless coverage.
The second component, the Central Monitoring Station, is capable of monitoring up to 500 patients. The monitoring system is customized for each patient who is enrolled in the program. Each patient’s electronic medical record will include patient demographic data, physician and family contact numbers and medication history. When a patient is admitted to the program, their primary physician will be asked to identify the acceptable high and low parameter of each vital sign. These parameters will be entered into the alarm setup window of the patient record.
When the central monitoring station receives the daily transmission from the patient’s home monitor, it compares the actual readings with the recorded parameters and displays the information in a way that the patient’s status can quickly be determined. The display utilizes screen location, color-coding and other information labels to visually convey priority and patient status. Any vital sign data that is outside of the prescribed parameters is flagged in red to notify the clinician to intervene. The care coordinator contacts the physician to determine if any change in the treatment plan is required. A tabular trend of the patient’s vital sign data is faxed or e-mailed directly to the physician.
The primary objective of the study is to reduce Medicare costs for patients enrolled in the treatment group by 20%. The results of this study will help determine the future reimbursement by the Centers for Medicare and Medicaid Services (CMS), formerly known as HCFA, for care coordination in chronic diseases such as congestive heart failure, diabetes, chronic obstructive lung disease, etc. The intended net results will be a reduction in Medicare and Medicaid healthcare costs and an improvement in optimal disease control and quality of life for patients with chronic disease.