What is a Clinical Research Study?
A clinical research study tests the effectiveness of an experimental drug, new medical devices or new procedures. For example, at St Vincent we have done all 4 phases of research on the new antibiotic drug Zyvox (Linezolid) which is used to treat Methicillin-resistant Staphylococcus Aureus (MRSA) infections.
In Phase I research studies, a drug or device is being tried in humans for the very first time. These studies usually involve a small group of participants (20-80). The purpose of the study is to ensure that the new drug or devise is safe. The studies are usually too small to tell whether the drug or device actually works.
In Phase II research studies, the study procedure, drug, or device is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III research studies, the study procedure, drug, or device is given to a large group of people (1,000-3,000) to confirm its effectiveness, and further monitor side effects. If Phase III trials are successful, the drug may be approved for sale to the general public. Even so, researchers continue to study the drug.
Phase IV research studies collect additional information about the drug's risks, benefits, and optimal use.
Clinical research participants are men and women of all ages and races. Researchers are starting to understand that some drugs work differently in men, women, children, or minorities. It is important to develop drugs and procedures that work well for everyone. Trials can be for healthy volunteers or participants with serious medical conditions.
When thinking about joining a study, remember that it is being done to learn what works, what doesn't work, or what works best. However, it is possible that subjects may not receive any benefit from the study and no guarantees will be made.
Making sure participants are safe is the top priority in all clinical research studies. For example, before any research study can start at Mercy St. Vincent Medical Center, it must be approved by a team of doctors, experts and community members called the Institutional Review Board. For safety reasons, not every person will be eligible for every study. Patients considering participating in clinical research should talk about it with their doctors and medical caregivers.
If you or someone you know is interested in participating in research at Mercy St. Vincent Medical Center, you may contact our research department at 419-251-4919.
What do you have to do to Participate?
Everyone must sign an Informed Consent Form in order to participate. You must also meet the inclusion/exclusion criteria set for the particular study. You must be willing to follow the directions and instructions of the research team. You must be willing to attend all study visits and you must take any study medications or complete any procedures exactly as directed.
Clinical research/trials are not for everyone, and sometimes new drugs or medical devices turn out not to work. However, many times the research leads to important medical advances that can benefit participants and future patients.
Who Performs Research?
Research is a collaboration between doctors, hospitals, pharmaceutical and sponsor companies. The research is performed by health care professionals in every specialty, from family practitioners to surgeons. It can be performed at large hospitals or small community clinics. St Vincent is involved in research in Oncology, Pediatrics, Infectious Disease, Pulmonary and Cardiac services, as well as other specialties.
Why is Research Important?
From the medicines you pick up at the pharmacy to the most advanced surgery, modern medicine would not be possible without clinical research. Without research, medicine and technolgoy cannot move forward. In fact, the government requires that clinical research be done on every new medicine before doctors can prescribe it.
Clinical research helps to take the guesswork out of designing new drugs and medical devices. A clinical research study allows doctors to find the most effective method of care.
Participant Resources and Support
Many changes have occurred over the years to protect people who decide to join a research project. If you decide to take part in research, you cannot be forced to do something you do not want to do, and you have the right to leave a study at any time, for any reason. Federal laws are in place to protect participants’ rights.
The Mercy St. Vincent Medical Center Adult IRB (Institutional Review Board) is the group that reviews all research projects before they begin to ensure they are as safe as possible and that your rights are protected. No study can begin without their approval. The group includes doctors, nurses, hospital staff and community members and can answer questions about your rights if you are thinking about taking part in research.