FAQs
- How long will the clinical trial last?
- Am I charged for study medications or procedures?
- How long are the visits?
- What is the “process” of a study?
- How might this study affect my daily life?
- What kind of screening do I have to go through to qualify as a study subject?
- What are the eligibility requirements to participate in the study?
- What kinds of Medical problems would keep me from partcipating in a study?
- Will I be able to take my usual medications during the study?
- Will I be able to see my own doctor?
- What happens if I react adversely from the study medications or procedures?
- What happens if I decide to quit the study?
- Glossary of research terms:
- For more FAQ’s please visit:
1. How long will the clinical trial last?
Currently, we have studies that range from 11 weeks to 64 weeks and some in between. Again, each study is different. The number of visits is also dependent on each study. Some require weekly visits and some require every month, every other month, every 6 weeks, etc. Most studies require phone visits with the research coordinators which involves blood sugar reviews, adverse effect review, dose adjustments, and to answer any questions or concerns you may have during the course of the study.
2. Am I charged for study medications or procedures?
Absolutely not. All study related diagnostic procedures, visits and medications that are a part of the study are provided to you free of charge.
Typically the first few visits can be a bit lenghty (2-3 hours). This is due to the screening procedures that will be completed to determine if you are healthy and eligible to continue in the study. We usually know this by the third visit when you are “randomized” into the specific part (or arm) of the study. The lengths of the visits vary (depending on the study) but generally are 1 hour. See “more info” under each study tab.
4. What is the “process” of a study?
- You become familiar about the study by reading the consent form and speaking to one of our research coordinators to answer questions you may have.
- A short screening process will be done to determine if you are meeting minimal criteria for the study you are interested in.
- If you meet minimal criteria, a longer screening process is done (usually by phone) which takes about 10-15 mins.
- If this extended screening is successful, then you will be scheduled for your first screening visit.
- If all study related lab work and diagnostic testing are successful, you will then proceed to being an active study “subject”.
- You will be assigned a “screen number” and a randomization number. Only your initials, birthdate and assigned numbers are used to identify you on the data we send to the sponsor.
- You will be “randomized” in the study, in otherwords, 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.
- Future visits will be scheduled and study materials will be given.
5. How might this study affect my daily life?
Most studies minimally affect your daily life. As a diabetic who cares about his/her disease process, you will be asked to track blood sugar readings and medication use. The study may require more testing that you may be accustomed to, but usually not anymore than your healthcare provider may expect of you. Dietary practices, exercise logs may be asked of you for some studies, but again, this is not only to capture valuable data for the study, and we take great pride in using this information to help you learn more about your diabetes and how to manage it! We encourage you to share this information with your primary health care provider during your regular visits.
6. What kind of screening do I have to go through to qualify as a study subject?
Most studies may require the following:
- EKG
- Lab work
- Physical exam
- In addition, depending on the study, chest xrays and pulmonary function testing. Some studies require lab work on every visit, some only periodically. Each study requirements are different. The research coordinators will review the study specifics with you. For examples, see “more info” under the specific study tabs.
7. What are the eligibility requirements to participate in the study?
Each study’s requirements are different. A research coordinator will review the specific criteria with you during the screening process.
For specific study information see the “more info” tab under each specific study heading and follow links to: http:www.clinicaltrials.gov
8. What kinds of Medical problems would keep me from partcipating in a study?
Most IDERC studies require a person to be in relatively good health. Problems that may exclude a person from partcipation are:
- Heart Disease/failure/abnormal ECG
- Stroke history
- Renal (kidney) disease/dialysis
- Use of steroid medications
- Pregnancy (or becoming pregnany during the study)
- Liver disease, Hepatitis, Cirrhosis, HIV
- Substance abuse or dependence
- Active or recent cancer
- Severe psychological conditions
- The research coordinators will review your health history with you during the screening process
9. 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 while in the study. You will be made aware of any changes needed and a substitute medication will be suggested. We will work with your PCP to make necessary changes if needed.
10. Will I be able to see my own doctor?
By all means! We expect and encourage all partcipants to maintain their relationships with their primary health care providers (PCP’s). IDERC will only manage the aspects of diabetes management that pertains to the study protocol. All other related health concerns will be managed by your provider usually responsible for these issues. We are happy to inform your PCP of your participation and share results of lab work, diagnostic testing, etc. (with your permission, of course).
11. What happens if I react adversely from the study medications or procedures?
First, it is extremely important to keep the study team up to date with any concerns you have regarding your health during the study. The “principle investigator” (PI) or 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, dosages, etc. or if severe, you may be removed from the study. Your health and safety are our number one priority during the study.
12. What happens if I decide to quit the study?
Absolutely nothing. You are free to stop partcipation at any time. You may be asked to return for a final visit to ensure safety and wellbeing after your participation ends. You may 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.
13. Glossary of research terms: http://www.clinicaltrials.gov/ct2/info/glossary
14. For more FAQ’s please visit:
http://www.cancer.gov/clinicaltrials/learning/page1
Even though this is a website for cancer studies, the information is excellent for all persons considering being involved in any kind of clinical research