Clinical Research Division

Before a clinical research trial is done at our office, the medication or device has already been through multiple trials starting in a chemistry lab, then with Petri dishes of cells, with animals, and finally with healthy volunteers. At every stage, the first focus is on whether the compound being studied is safe to use. Protecting the rights, safety, and welfare of individuals who participate in clinical trials is paramount. FDA regulations and guidelines for clinical trials help support effective medical product development while ensuring trials generate enough evidence needed to assess product safety and efficacy.

To learn more about the safety of clinical trials visit: https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection

Once someone is identified as a potential fit for a trial, we ask their doctor if they know of a reason the person should not participate. We trust your doctor to know you, and to have your best health at heart. Next, we tell you a bit about the trial and invite you to make an appointment to discuss the trial in detail. This visit is called “Informed Consent”. This doesn’t mean you have to agree to be in the trial, but that we will be giving you all the information you need to make a good decision for yourself. We encourage you to bring someone with you if their opinion will matter in making the decision. While many people are ready to make their decision at that time, some people want to take the information home and think more about it, which is perfectly fine.

Being in a trial is voluntary, both in starting a trial and in completing the trial. While almost everyone completes their trial with no problems there are a few instances where someone will not. Rarely, someone has a side effect that makes them withdrawal from the study or the results of the lab tests may show a reason they should not continue in the trial. Sometimes a change in life circumstances, work schedule or other unforeseen circumstances is the reason they have to withdrawal. While we wish all participants could complete the trial, we understand that this may not always be the case. This is permitted and there is no penalty in doing so.

This question doesn’t have a simple answer. Every trial we offer is one selected because the science behind the trial makes sense and all the preliminary research looks promising, however, there are several other factors to consider. First, in every trial some participants get the treatment being studied and some do not (this is called a Control Group). Having some individuals not get the new treatment is essential to know if the study medication works. So, you might get the study medication, or you might not. Second, the study medication also might work in general but isn’t right for you. No medication works for every person. Lastly, sometimes the study medication just does not give the results we expected. Either it doesn’t work or it doesn’t work well enough. This is always a disappointing finding, but it is still relevant and important information. Think about it this way: if your GPS told you that you made a wrong turn half a block after you did it, it’s still better than figuring it out half an hour later.

We can’t promise that your health will get better by participating in clinical research, but we can promise that you will be working to help develop better treatments for everyone.