A multi-disciplinary lab dedicated to increasing equity by decreasing disparities in diabetes.
Frequently Asked Questions - The Lab
Our lab is involved in a wide range of primary care research, with a focus on diabetes research.
Each study has its own set of unique eligibility criteria. If you’re looking for information about a specific study, email us at PrimaryCareDiabetesLab@cuanschutz.edu for more information.
Join our community of diabetes discovery! We are building a community of patients and researchers who will partner together in research to advance knowledge about diabetes and managing it. Please consider joining our team and becoming part of a registry
of people who are willing to be contacted about potential research opportunities.
Clinical studies are research studies in which real people participate as volunteers. Clinical research studies are a means of improving our understanding of disease, such as in observational studies, or developing new treatments and medications for diseases
and conditions, such as clinical trials, which are evaluating the effects of a biomedical or behavioral intervention on health outcomes. There are strict rules for clinical trials, which are monitored by the National Institutes of Health for the trials
it funds, and the U.S. Food and Drug Administration more broadly. Some of the research studies at the Clinical Center involve promising new treatments that may directly benefit patients.1
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial
in the quest for knowledge that will improve the health of future generations. Without your help, research studies cannot be accomplished.
A volunteer subject with no known significant health problems who participates in research to test a new drug, device, or intervention is known as a "healthy volunteer" or "Clinical Research Volunteer." The clinical research volunteer may be a member of the community, an NIH investigator or other employee, or family members of a patient volunteer. Research procedures with these volunteers are designed to develop new knowledge, not to provide direct benefit to study participants. Clinical research volunteers have always played a vital role in medical research. We need to study healthy volunteers for several reasons: When developing a new technique such as a blood test or imaging device, we need clinical research volunteers to help us define the limits of "normal." These volunteers are recruited to serve as controls for patient groups. They are often matched to patients on such characteristics as age, gender, or family relationship. They are then given the same test, procedure, or drug the patient group receives. Investigators learn about the disease process by comparing the patient group to the clinical research volunteers.
Placebos are harmless, inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being given works better or no better than ordinary treatment. In many studies, there are successive time periods, with either the placebo or the real medicine. In order not to introduce bias, the patient, and sometimes the staff, are not told when or what the changes are. If a placebo is part of a study, you will always be informed in the consent form given to you before you agree to take part in the study. When you read the consent form, be sure that you understand what research approach is being used in the study you are entering.
Medical research is dogged by the placebo effect - the real or apparent improvement in a patient's condition due to wishful thinking by the investigator or the patient. Medical techniques use three ways to rid clinical trials of this problem. These methods have helped discredit some previously accepted treatments and validate new ones. Methods used are the following: randomization, single-blind or double-blind studies, and the use of a placebo.
Randomization is when two or more alternative treatments are selected by chance, not by choice. The treatment chosen is given with the highest level of professional care and expertise, and the results of each treatment are compared. Analyses are done at intervals during a trial, which may last years. As soon as one treatment is found to be definitely superior, the trial is stopped. In this way, the fewest number of patients receive the less beneficial treatment.
In single- or double-blind studies, the participants don't know which medicine is being used, and they can describe what happens without bias. Blind studies are designed to prevent anyone (doctors, nurses, or patients) from influencing the results. This allows scientifically accurate conclusions. In single-blind ("single-masked") studies, only the patient is not told what is being given. In a double-blind study, only the pharmacist knows; the doctors, nurses, patients, and other health care staff are not informed. If medically necessary, however, it is always possible to find out what the patient is taking.
Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.