We understand that you may have questions before making your decision to volunteer for our clinical trials. Here are some questions and answers to help you make an informed decision.
Why should I participate in a study?
There are many rewarding reasons why you should volunteer to become a study participant. By participating in a clinical trial, you are contributing to the future of healthcare as well as potentially improving the quality of life for people around the world. In addition, you also will be compensated for your time.
Is it safe to participate?
There is always a risk in taking medication, whether it’s over-the-counter or prescribed by your own physician. We do everything we can to minimize risk, starting with making sure our study participants are the right fit for each trial. This involves initial screening and testing. Of course, we count on our participants to be completely honest when giving their medical histories. Our facilities are built specifically to accommodate clinical trials by offering a safe environment with licensed medical professionals who oversee studies throughout the duration of the program.
Are studies regulated?
All studies conducted by Cliantha Research adhere to the safety guidelines issued by the Food and Drug Administration (FDA) and other global regulatory agencies. In addition, clinical trial protocols are reviewed and approved by an Ethics committee or Institutional Review Board. This committee ensures that participants are not put in undue risk and that the research organization has proper safety measures.
Are there any age restrictions?
Each study is different and is dependent on the Inclusion & Exclusion criteria.
What happens in clinical studies?
We conduct studies that look at a drug’s reaction and effectiveness in healthy individuals, and in those who may have conditions that require a treatment similar to what is being tested. Rest assured, this is done in a very safe and controlled environment. During some trials, different types of tests will be done, including blood and urine tests, and electrocardiograms (ECGs). But since each trial is different, you will get a full explanation before participation.
Do trials require an overnight stay?
That all depends on the study. Some studies require you to stay for just the day. Some may require you to stay the night. Others may involve a weekend or consecutive weekend stays, starting on a Friday night and ending Sunday. This information is always provided to you before committing to participation.
What can I expect from the facilities?
Depending on what type of study is conducted, the number of participants can be anywhere from a small group to as many as 500 volunteers. Our sleeping areas are like dormitory-style rooms, with different activity areas where you can socialize or just watch TV. There are also quiet areas where participants have the freedom of reading or studying.
What is there to do in the facilities?
There’s plenty to do between tests. You have your pick of games, books, movies, computers, watching TV and other recreational activities. It’s also a good idea to bring something from home to work on while you’re here.
Will meals be served?
Absolutely. For research-control purposes, all participants will be served the same menu and can only eat the food we provide. No outside snacks or beverages are allowed, including candy and gum.
Can I withdraw from a study even after it starts?
You have the freedom of leaving at any point during the study. However, you will only be compensated for the time you participated in the study.
How often can I be a study participant?
For safety reasons, you are required to have “washout period” of a minimum of 30 days after the end of a study before volunteering for another one. This washout period allows your body to rid itself of any remaining investigational drugs and regenerate blood withdrawn as samples during the study. In some cases, you may have a 90-day or more rest period, depending on the study requirements.
What are some other questions I may want to ask?
What drug will be tested?
What is the main reason for the study?
How are the drugs administered?
What type of medical staff will be available during the study?
What is the compensation based on?
How much research and trial experience does your company have?
What happens if I cannot complete the study?
Will my participation be anonymous?
What if I have food or other allergies?
What if, due to personal beliefs, I cannot eat what is served?
Do I need to bring my own toiletries?
What if I am currently taking over-the-counter medication?