There are many reasons to conduct research trials. One such reason is to help our study team gather data on investigational medications or investigational medical devices. This information can be used to help you and potentially other people with the same disease. Many times, the trial medications or devices are new and not yet approved by the FDA or other-times they are already on the market, but are trying to get approved to treat an additional condition. You, as one of our patients become an important part of our team in helping to gather that data.
Frequently Asked Questions
We have a responsibility to you to inform you of what you’re taking. That includes the history of the product and any side effects or discomforts seen with the product in previous studies. Some studies have a placebo, or sugar pill. With these clinical trials, there is a chance that you are receiving placebo. For those trials neither us nor you will know if you’re getting the placebo or the actual product.
This depends on the study but there are some common procedures you will see in all of our trials. For example, the gathering of vital signs, e.g. height, weight, blood pressure, body measurements, are common to nearly all clinical trials. Other commonly done procedures are blood draws, urine collection, questionnaires, and imaging. Additionally, some studies may have liver biopsies. Your coordinator will review all potential symptoms with you prior to signing the consent.
We do our best to let you know of all potential side effects before you even start the research trial. There are sometimes though, where we will become aware of a new side effect after you’ve already started the investigational product. In those cases, as soon as we become aware of it, we will let you know too.
In addition to potentially receiving help for your condition, you may also learn more about your condition. Our doctors are always happy to answer any and all questions you may have about your condition or any other aspect of the study. Please write your questions down on a notebook and bring them to the visit.
This depends on the study but there are some common procedures you will see in all of our trials. For example, the gathering of vital signs, e.g. height, weight, blood pressure, body measurements, are common to nearly all clinical trials. Other commonly done procedures are blood draws, urine collection, questionnaires, and imaging. Additionally, some studies may have liver biopsies. Your coordinator will review all potential symptoms with you prior to signing the consent.
Enrolling into a trial is completely voluntary. You always have the ability to say “no” to participating in any trial, at any time during the trial. One can even withdrawal after enrolling in a trial. You have the right to withdraw at any time. Deciding to not participate will not cause any penalty or loss of benefits.
Research trials are funded by pharmaceutical companies. As a volunteer for a research trial all expenses are covered by the pharmaceutical company sponsoring the trial. You or your insurance will NOT be expected to pay for any study procedures or investigational products while you are in the trial. While in a research trial, you will have to pay for your usual medical care though. For instance, if you are being treated for diabetes that requires a medication prior to starting a trial, and the medication is not the one being studied by the trial, you will still have to pay for that same diabetes medication while you’re enrolled.
Some trials compensate volunteers. However, each trial has different requirements. If the trial does compensate volunteers, for the reasonable cost of time and travel required to participate in our research trials, you will be notified. This amount can vary from trial to trial and we will let you know of that amount prior to you enrolling.
NASH stands for non-alcoholic steatohepatitis. This disease is known as fatty liver with inflammation. The difference between NASH and Fatty liver is both have fatty liver but NASH also has inflammation.
Treatment for NASH is limited as to date there are no approved FDA therapies. However, life style modifications are first step: diet and increased activity. The FDA has numerous approved pharma trials offered at numerous research sites across the United States. We offer several of these therapies at South Texas Research Institute
The exact cause or etiology for NASH is not well known. Of concern is that 40% of patients with Diabetes Mellitus II have NASH. Certain ethnicities have higher rates as well, Hispanics, white men over 50 years of age, and Asians.
No. However, there may be a genetic risk or unknown risk issue, as the medical world continues to search for answers.