Frequently Asked Questions
Q-What is a research study?
A-A clinical research study is designed to determine the safety and effectiveness of new
investigational treatments under the close supervision of highly trained physicians and research
professionals. Clinical studies are conducted in four phases.
Phase I studies are conducted in healthy volunteers to assess the safety of the study medication
and are normally only conducted in a small number of volunteers. Generally the study
medication is given to less than one hundred healthy volunteers.
Phase II studies are to test the effectiveness of the study medication and generally involve a
larger number of volunteers with the disease under study. The number of volunteers increases
to several hundred.
Phase III studies also are conducted on a very large number of volunteers with the disease under
study to gain a better understanding of how the study medication will work in a more diverse
group of people. During this phase the medication is given to several thousand volunteers. After
the completion of this phase the information can be submitted to the Food and Drug
Administration for approval of the medication.
Phase IV studies are post market studies. These studies are completed to compare the study
medication to others currently on the market and monitor the long term effectiveness .
Q-Who oversees a research study?
A-An ethics committee, called an Institutional Review Board (IRB), must approve a study prior to
initiation. The IRB must also examine all information being provided to patients.
A research study is conducted by a physician and research staff. The information that is
collected from volunteers is then monitored by a company hired by the pharmaceutical
company to collect and assess the data. This data is then reviewed by the pharmaceutical
company that is sponsoring the study.
Ultimately the Food and Drug Administration (FDA) assesses the data to make the decision on
the medication coming to market. The FDA can, at any time, stop a research study at a site or
the entire study if it feels there is a safety issue for volunteers.
Q-Who can participate?
A-The pharmaceutical company that sponsors the clinical study sets up specific guidelines called inclusion and exclusion criteria that determine who is eligible to participate. These criteria ensure the safety of the volunteers. Researchers seek a diverse population of patients. They need all races and genders because people respond differently to medications.
Q-What are the benefits and risks of participating in a research study?
A-Benefits to volunteering include gaining access to new research treatments before they are made widely available, helping others by contributing to medical research, access to medical care that you might not otherwise have and playing a more active role in your healthcare.
Just like taking any form of medication, there are risks associated with clinical research. The treatment you receive may not be effective, there may be unpleasant effects from the treatment and the study may require more time, including trips to the study site than conventional treatment.
Q-Is insurance required? What happens with my regular doctor?
A-No insurance is required. In research studies all study related procedures are completed at no charge, your insurance will not be billed for any study procedures.
You do not leave your medical doctor to participate in a research study. The study doctor will monitor the disease under study for the course of the study but not your other health concerns, for these you will need your doctor. The research staff will need to collaborate with your doctor for updates on your health.
Q-What is a placebo?
A-A placebo is an inactive substance that is used as a comparator in clinical research studies. The medication under study is often compared to a placebo to assess the effectiveness of the medication. A placebo is made to look exactly like the medication under study, you will not know if you are being treated with the active study medication or placebo based on the look of the medication you receive.
Q-Will I be compensated?
A-Yes, once you are enrolled. You will be compensated for your time and travel at each required visit you make to the study site. Meals are provided when you are on site for extended visits or if you are required to fast for specific study related procedures.
Q-How am I protected?
A-The research study is conducted by trained research professionals and is governed by the ethical code of conduct of medicine. Federal Regulations and Good Clinical Practices along with The International Code of Harmonization are in place and must be followed for the safety of research volunteers. An Institutional Review Board (IRB) is an ethics committee that oversees the conduct of the study and can be contacted at any time. They are independent of the site and the pharmaceutical company and made up of members of the community, doctors, nurses, clergy and attorneys.
Your private medical information will be protected under the rules of Health Insurance Portability and Accountability Act (HIPPA) just as it would be at a conventional treatment center. In a research study your information is de-identified prior to being submitted to the pharmaceutical company. The information collected from your participation is what the pharmaceutical company is seeking, not your name and address.
Q-What can I expect if I volunteer at Emerald Coast Research Associates?
A-You can expect a dedicated professional research team that is genuinely interested in your health. At ECRA our emphasis is on patient education and safety. You can expect our team to collect and carefully review your medical records to guarantee that you meet the requirements set forth by the sponsor. You can expect your study medication and all study related procedures to be at absolutely no cost to you and that you will be compensated for your time and travel once you are enrolled. You can expect to be closely monitored and have 24 hr access to our study staff.
Q-What happens after the trial ends?
A-When the trial ends volunteers enter a follow up period where they are returned to their previous plan of care and medications. This period will include telephone calls or sometimes a follow up visit to the study site. You will no longer have access to the medication under study. The process that leads to the marketing of these medications often takes years. For this reason many volunteers chose to participate in other studies. You must wait 30 days between studies and you can not participate in two studies at one time. You will return to the care of your regular physician for all of your needs after the completion of the follow up period.