In what medical areas are your clinical studies?
Our clinical studies are in a wide variety of disciplines. Please see a more complete description on our Areas of Research webpage.
What is a clinical study?
A clinical study is a research study to answer specific questions about new therapies or devices, or new ways of using known treatments. Clinical studies are also called research studies and are used to determine whether new drugs or treatments are both safe and effective.
Who can participate in a Clinical Study?
All clinical studies have guidelines called inclusion/ exclusion criteria that determine who can participate in the program. These guidelines are based on such factors as age, type of disease, medical history, and current medical conditions. These criteria are used to identify appropriate participants and keep them safe as well as to ensure that researchers will be able to answer the questions being asked.
What are the benefits to me if I participate?
There are both benefits and risks associated with clinical studies. While participating in a clinical study you can:
- Take an active role in your own health care
- Gain access to new treatments that are not available to the general public
- Obtain medical care
- Help others by contributing to medical research
Will I be paid for participating?
Some clinical studies will pay you for time and travel while others will not. This will be clearly outlined in the informed consent. The office visits related to the clinical study as well as some diagnostic tests may also be provided.
What protections are there for participants in a clinical study?
The government has strict guidelines and safe guards to protect people who choose to participate in clinical studies. Every clinical study in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure risks are as low as possible and are worth any potential benefits.
What is an informed consent?
Informed consent is the process of learning the key facts about a clinical study before you decide whether or not to participate. The facts include: why the research is being done, what the researchers want to accomplish, what will be done during the study and for how long, what risks are involved in the study, what benefits can be expected from the study, what other treatments are available, and the fact that you have the right to leave the study at any time.
You will receive an informed consent document and given an opportunity to read it and ask any questions. A copy of it will then be given to you.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical studies, experimental treatments are often compared with placebos to assess the treatment's effectiveness. The informed consent will describe the chance, if any, if you will receive a placebo during the clinical study.
What should I know before I join a clinical study?
You should know as much as possible about the research study. It is very important for you to feel comfortable and have all your questions answered by the staff in a way that you can understand.
What are the risks of participating in a clinical study?
Clinical studies have risks:
- There may be side effects or adverse reactions to medications or treatments
- The treatment may not be effective for you
- It may require extra trips to the study site
How qualified is your staff to conduct clinical studies?
Charlottesville Medical Research has been conducting clinical studies since 1991. Many of the staff have had clinical study experience prior to that time. Coordinators are certified by the Association of Clinical Research Professionals and carry the title Certified Clinical Research Coordinator. All of our physicians have research experience and function under federal guidelines known as the Good Clinical Practice Acts.
Who sponsors clinical studies?
Clinical studies are sponsored by Government agencies, pharmaceutical companies, individual physician investigators, and organizations that develop medical devices. Studies can take place in hospitals, doctor's offices, or universities, as well as independent research facilities.
Can I leave a clinical study after it has begun?
Yes. You can leave a clinical study at any time. If you plan to stop participating, let the research team know why you are leaving the study. You will need to return to the study site to be withdrawn from the study.
Do I have to go to a hospital?
Some studies are done within a hospital but many are done in an office setting. The informed consent will clearly outline what is required.
If a drug is already FDA approved, why do they call it investigational?
Any time a medication is studied in a research fashion, it is called "investigational". The consent form will explain if it is FDA approved.
Will it cost me to participate?
Usually no cost will be incurred by participating in a clinical study. This will be clearly outlined in the informed consent.
How do I volunteer?
To volunteer for one of our studies or to find further information please contact us.