Here are a few reasons you might want to look into participating in TPMG’s clinical research studies.
Clinical Research Division
The Clinical Research Divisions at Tidewater Physicians Multispecialty Group (TPMG) conduct ongoing clinical research trials at our Williamsburg and Newport News locations. Since its founding in 2016, our clinical research team has more than 60 years of combined experience in leading, co-investigating, and coordinating clinical research trials for a wide range of conditions. Clinical trials are essential to the advancement of new therapies and improved patient outcomes. These trials test the safety and effectiveness of medications and devices under the supervision of physicians and trained medical professionals. Patient contributions can help future generations lead healthier lives. Medical breakthroughs cannot happen without the participation and support of clinical trial participants.
Research may involve medications or devices approved by the Food and Drug Administration (FDA), or those that are still in their study phase prior to FDA approval. All clinical trial phases are governed by strict protocols and overseen by regulatory entities from the FDA to Institutional Review Boards (IRBs). IRBs are a group of individuals designated to review and monitor biomedical research involving eligible testing participants. IRB reviews ensure appropriate steps are taken to protect the rights and welfare of involved participants. The entire research team is skillfully trained in clinical practices, following strict adherence to FDA guidelines.
Our Clinical Research Divisions offer flexible scheduling and monitoring of all research participants. All study-related procedures/examinations – physical exams, lab work, and imaging studies, are conducted at no cost. Health insurance is not needed to enroll in any of our clinical studies. Many of these studies involve compensation; for more details, please contact one of our clinical trial coordinators. In accordance with the Health Information Portability and Accountability Act (HIPAA), patient privacy is protected and medical records are kept confidential.
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Frequently Asked Questions
FAQ – Clinical Research
What is Clinical Research?
Clinical Research is a tool used to answer questions. Every study begins with a question, such as “Will this new medication (or, device) work?” “Is it an improvement over existing treatment options?” By looking at how the medication behaves under the specific, controlled protocol of the study, we can learn how well the medication does the job for which it is being given and learn if there are any harms or unexpected benefits from it.
Isn’t it risky to participate in research?
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
How do I know if a trial might be right for me?
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.
If I enroll in a trial will I be forced to stay in it?
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.
Will my health get better (or, worse) if I enroll in a trial?
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.
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