About Clinical Trials
Medical research provides a special opportunity for members of the community to join forces with our pioneering physicians, nurses and researchers by participating in a clinical trial. In a clinical trial, patients or other volunteers answer specific questions about current or new treatments, diagnostic tests and other clinical issues. A popular form of clinical research, the clinical trial the best way to compare two or more aspects of care, such as treatment methods.
If you are interested in participating in a clinical trial, please review the below frequently asked questions or call us at 888-584-7888 for more information.
Frequently Asked Questions About Clinical Trials
What is medical research? Medical research is the careful, organized investigation of human health and disease. Improved medical care is based on scientific medical research.
What is clinical research? Clinical research involves human volunteers in the study of human health and disease. Research can be as simple as completion of a health survey or may be more involved with testing of an advanced therapy for a life-threatening disease. An important subgroup of clinical research is clinical trials.
What is a clinical trial? A clinical trial is a special form of clinical research in which participants who volunteer help evaluate a new medical test and/or treatments. Trials are often used to find new and improved methods of treating diseases and special conditions.
What are the benefits of research participation? Research participants:
- Help others in the future, even future generations of their own families
- Make valuable contributions to medical research
- May be the first to benefit from a new diagnostic or treatment method being studied
- May have access to investigational drugs and procedures before they are widely available
- Receive watchful attention to changes in their health from a member of the research team
What are the risks of participation? Participants are told about any known risks or side effects of tests and/or treatments before the clinical research begins. As with regular clinical care, treatments may:
- Be ineffective or less effective than existing treatments
- Have side effects or risks unknown to the doctors
- Not work for you, even if it is effective for others
How are participants protected? All of our medical research is in full compliance with federal research regulations and recommendations. We highly value ongoing surveillance for the health, safety and privacy of our research participants.
Before any clinical research starts at Loyola, the research plan is carefully reviewed by the Institutional Review Board (IRB), a committee of physicians, nurses and non-medical experts. The primary responsibility of the IRB is to make sure that research participants are protected.
Potential research participants are provided a written document (research consent) that has been approved by the IRB. This written document reviews the potential risks and benefits and the scientific reasons for performing the medical study. You may keep your copy of this document.
Who is eligible to participate in a clinical trial? Research involves people of different ages, gender, diseases and health histories. People with the right mix of characteristics for a particular study may be eligible to participate. Eligibility criteria also help to exclude people with a condition or characteristic that may increase their risk during participation. For these reasons, not all volunteers for a clinical trial will qualify to participate.
Can a healthy person participate? Yes, depending on the type of research. Some studies recruit healthy volunteers to explore health, diagnostic tests and disease prevention and establish best doses for new therapies.
What is a research team? Typically a research team is led by a single individual (the principal investigator), additional individuals (co-investigators) and research nurses. Other behind-the-scenes research team members include data managers and coordinators. All of these individuals are certified to participate in human research.
What can a volunteer expect? You may be asked by a member of your healthcare team to consider volunteering for a clinical trial. Regardless of your research participation decision, your doctors will continue to take excellent care of you. For other studies, you may call to determine if you or a family member qualifies for the research program. Depending on the particular study, a member of the research team will take a medical history, run basic laboratory tests and perform a physical exam during a typical first research visit. Your healthcare team will also discuss with you the details of the study, including the potential benefits and risks.
If you agree to participate in the study, you will be asked to follow the instructions of the research team and tell them about any changes in health during the course of the trial. For most studies, participants will have regularly scheduled follow-up appointments for researchers to check their condition and collect information from tests and/or treatment results. The number and duration of these appointments vary from trial to trial. Participants may request that lab results be sent to their primary doctor so that they will not need to have tests repeated during non-trial exams.
By consenting to participate, a study participant plans to complete all research tasks as explained by the research team and in trial documents so that participation will produce accurate research information. However, at any point, a participant may withdraw from clinical research without jeopardizing clinical care.
How do I decide if participation is right for me? If you are asked to participate in a clinical trial, you have the right to ask questions and the right to choose not to participate. Your decision will never affect your relationship with your doctor or the care you receive at Loyola. Consider your research participation carefully. You may wish to discuss this decision with your primary doctor and family.
How long will I be in the research program? The length of a clinical research study varies; it may be a single visit, several days or up to several years. Potential research participants will be told how long the study is expected to run and what specific time commitment will be required of them.
Where is clinical research conducted? Clinical research visits will be held at one or more of the Loyola Medicine locations, including the Loyola Outpatient Center in Maywood and 17 primary and specialty care centers throughout DuPage, Will and western Cook counties. Your research team can tell you more details based on the specific study of interest.
Who pays for the costs of clinical research? Normally, healthcare costs are paid for by you or your insurance company. However, research costs are usually paid for when there is special testing, treatments or extra doctor visits that are required for research only.
Clinical research is paid for in several ways. Through taxpayers’ money, the National Institutes of Health (NIH) provides researchers with funds to improve the health of Americans. Several other governmental agencies fund research in a similar way. Pharmaceutical companies, medical device and equipment manufacturers, healthcare institutions and private organizations also fund research studies.
Information about trial sponsorship is available to those considering participation. Some clinical research studies provide small financial payments to cover the costs of travel for participants.
What happens when the clinical trial is completed? When a clinical research study is completed, the research team carefully examines the collected data and shares the results with the medical community. Usually, results are published in a scientific or medical journal. Particularly important results often are reported by the news media and discussed at scientific meetings and by patient advocacy groups. A drug or intervention proven safe and effective in a clinical trial is incorporated into standard healthcare practice. Once a trial is over, researchers will let individuals know if there is opportunity to participate in any future trial phase.