Frequently Asked Questions
What are the benefits of clinical research?
- Gaining access to treatments that are not yet available to the public
- Obtaining expert medical care, medication and supplies at no cost to you
- Helping others by contributing to the advancement of medical research
- Treatment may be more effective than the standard approach
- Taking an active role in your own health care and to gain a better understanding of your disease
What is the typical time frame of a research study?
Each study has a different time frame; we have studies that range from six months to five years. The number of visits is dependent on each study. Early on studies may require weekly visits and then typically become more infrequent, requiring just monthly visits. Most studies also require phone visits with the research coordinators. The phone visits may include a review of your blood sugar, any adverse effects, as well as dosage adjustments and an opportunity to address any questions or concerns you may have during the course of the study.
Am I charged for study medications or procedures?
All study-related diagnostic procedures, visits and medications are provided to you free of charge
How long are the visits?
Your first few visits may be longer (two to three hours on average) to allow time to perform all testing required to see if you are healthy and eligible for the study. Usually by the third visit, you will be “randomized” into a specific part, or arm, of the study. Randomization is the process of placing study participants into groups at random, much like flipping a coin. Subsequent visits will generally take one hour; however, lengths of visits can vary depending on the study.
What is the “process” of a study?
- First, you familiarize yourself with the study by reading the consent form and speaking with one of the IDERC research coordinators.
- Next, a short screening process will be done to determine if you meet the minimal criteria for the study. If you meet the minimal criteria, a longer screening process is done (usually by phone); the phone screen takes about 10-15 minutes. If this extended screening is successful, you will be scheduled for your first screening visit.
- Then you will complete study-related lab work and diagnostic testing. If your results qualify, you will proceed to being an active study “subject.” You will be assigned a “screen number” and a randomization number. Only your initials, birth date and assigned numbers are used to identify you on the data sent to the sponsor.
- Next, you will be “randomized” in the study. This means you will be assigned to a specific treatment group described in the consent. Randomization is truly just that, people are placed into “arms” or groups of the study based on a “random” selection that is often computer generated.
- Finally, future visits will be scheduled and study materials will be given to you.
How might this study affect my daily life?
Most studies will have minimal effects on your daily life. As a person with diabetes, you will be asked to track blood sugar readings and medication use. The study may require more testing that you may be used to, but usually no more than your primary health care provider may expect of you. Additionally, you may be asked to track your diet and exercise for some studies. This valuable data will not only be used for the study, but will also help you learn more about your diabetes and how to manage it effectively. We encourage you to share this information with your primary health care provider during your regular visits.
What kind of screening do I have to go through to qualify as a study subject?
Each study has a unique set of requirements. The IDERC research coordinators will review the study specifics with you.
Most studies may require the following:
Most studies may require the following:
- Lab work - Some studies require lab work with every visit, while others only require periodic testing
- Physical exam
- Depending on the study, other diagnostic testing may be required and will be discussed with one of the coordinators
What are the eligibility requirements to participate in the study?
Each study’s requirements are different. An IDERC research coordinator will review the specific criteria with you during the screening process. For specific study information, click “Trial Details” under each study in the Current Trials section.
What kinds of medical problems would keep me from participating in a study?
Most studies require a person to be in relatively good health; however, each study has its own requirements. The IDERC research coordinators will review your health history with you during the screening process.
Will I be able to take my usual medications during the study?
Most of the time, this answer is yes; however, certain medications may not be compatible or preferred for use while you are part of the study. You will be made aware of any changes needed and a substitute medication will be suggested. We will work with your primary care physician to make any necessary changes.
Will I be able to see my own doctor?
We expect and encourage all participants to maintain their relationship with their primary health care providers. IDERC will only oversee the aspects of diabetes management that pertain to the study protocol. Your primary care provider will manage all other health-related concerns. We are happy to inform your provider of your participation and, with your permission, share lab work, diagnostic testing, etc.
What happens if I have an adverse reaction to study medications or procedures?
Your health and safety are our number one priority. During the study, it is extremely important to notify the study team of any concerns you may have regarding your health. The principle investigator (PI) physician overseeing the study will determine if the adverse effect is related to the study medications or procedures. If so, you may need to stop or change the study drug or dosages. If the reaction is severe, you may be removed from the study.
What happens if I decide to quit the study?
You are free to stop participating in the study at any time. After your participation ends, you may be asked to return for a final visit to ensure your safety and well-being. You may also be asked to return study medications and documents. You will never be charged for study-related care and your study compensation for your participation will be addressed as outlined in the specific consent process.
What are the phases of a clinical research study?
- Phase I trials: These first studies evaluate how a new drug should be given (by mouth or injected into the blood or muscle), how often it should be administered and at what dosage. A Phase I trial usually enrolls only a small number of healthy volunteers, sometimes as few as a dozen.
- Phase II trials: A Phase II trial continues to test the safety of the drug in people with the medical condition to be treated and begins to evaluate how well the new drug works, and determines the appropriate dosage.
- Phase III trials: These studies test a new drug, a new combination of drugs or a new surgical procedure in comparison to the current standard in people with the medical condition to be treated. A participant is typically assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and centers nationwide or even worldwide.