What is a clinical research study?
A clinical research study, sometimes referred to as a clinical trial, is a carefully designed and highly regulated study of the safety and effectiveness of new, innovative medicines, procedures or equipment. The purpose of the study is to determine if the new course of treatment will be effective in preventing, diagnosing or treating people with specific illnesses or conditions.
All participants in a clinical research study must first volunteer to be in the study. Volunteers must sign an informed consent which details the nature of the study. The form presents any risks involved and lets volunteers know they may choose to leave the study at any time.
All clinical research studies are approved and monitored by an Institutional Review Board (IRB). The main role of the IRB is to ensure that the study is conducted in a safe manner. Patient safety is of the utmost concern in any clinical study.
Benefits of volunteering for a clinical research study
- Volunteers help others by advancing medical knowledge about a particular disease or condition.
- Possible self health improvement.
- Receive treatment options that might not otherwise be currently available.
How are participants in a clinical research study protected?
- The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) make and enforce rules to ensure that participants in a study are treated as safely as possible.
- The IRB consisting of doctors, scientists and community leaders, grants approval for clinical research studies only after reviewing the scope and nature to ensure that patient safety is adhered to.
- The physician study investigator and the research coordinator are trained to follow the federal guidelines to carry out the study. They explain the study to the volunteer and make certain that the protocol, or detailed plan, is followed.
- By signing and reading the informed consent form, volunteers are provided details about the study, including any known risks and future contact information.
Questions a participant should ask
Feel free to ask questions before, during and after a study is performed.
- Who is doing the study?
- Why are they doing it?
- How long will the study last?
- What will be done to me (Blood tests, exams, x-rays, etc.)?
- What will I have to do during the study?
- What are the possible risks (Side effects or discomfort)?
- Is it possible that some risks are not known yet?
- What are the possible benefits?
- How many visits will be required?
- Where will I have to go?
- Will I get a placebo and what is it?
- Who can I contact if I have more questions or problems during the study?
- Will I be hospitalized during the study?
- What if I am injured or become sick during the study?
- What kind of follow-up will there be after the study?
- Will there be any cost to participate in the study?
- Will I be compensated in any way for participating in the study?
- Will my insurance be billed for any part of the study?
- Who will see the information that I give or is collected about me during the study?
Who can participate in a clinical research study?
Everyone has the right to apply to participate in a clinical research study. However, because each study is designed to answer a specific research question, not everyone who applies may be granted admission into the study.
Guidelines that determine who may enroll in a particular study are meant to ensure reliable results and to protect study participants.
Why doesn't it cost anything to participate in a clinical research study?
Research is funded by sponsors (i.e., pharmaceutical companies, government, etc) who pay for the costs of research related medical procedures and physician office visits. There is no cost to the patient or insurance companies for these research related procedures and doctor visits.
Where is your office located?
The Community Clinical Research Center is located south of Community Hospital Anderson. As you turn onto Medical Arts Blvd from Madison Avenue, our facility is a located on the left side of street across from the hospital.
Community Clinical Research Center Address:
1221 Medical Arts Blvd
Anderson, IN 46011
We are also located in Muncie on Oakwood Avenue to the south of McGallard. The Muncie Medical Pavillion is located right behind the Sunshine Café.
Community Clinical Research Center Muncie address:
3025 N. Oakwood Ave.
Muncie, IN 47304
When is your office open?
Our office hours are: 8am-4:30pm, M-F. Appointments can be arranged before or after office hours.
Who should I call?
Please call our office (765-298-2040) to speak with a CCRC Representative.