CLINICAL RESEARCH AT CFPG
Our clinical research team consists of a medical director, clinical director, principal investigator (physician who oversees a specific study), sub-investigators (physicians who assist with specific studies) clinical research coordinators, respiratory therapists, medical assistants and a regulatory specialist.
Each individual study has an assigned principal investigator physician, numerous sub-investigator physicians, a main clinical research coordinator and a back-up coordinator, as well as the appropriate ancillary support staff.
Clinical research studies are strictly monitored by the US Food and Drug Administration (FDA). These studies investigate how well a new drug, vaccine, or medical device works for a specific condition. Studies answer scientific questions and try to find better ways to prevent, screen, diagnose and/or treat diseases. There are six types (phases) of studies. CFPG participates in four of these types: I, II, III, and IV.
To volunteer for a study, you need meet a specific criteria. These criteria include age, gender, type of disease, medical history and other past or ongoing medical conditions. Criteria varies for every clinical research study. Talk to our Clinical Research Department for more information about a specific clinical research study.
Clinical research studies are available in all of the CFPG offices. In order to conduct a wide variety of studies, not every study is available in every office. But every study is available to every person who meets the specific enrollment criteria. Some Phase I studies require overnight stays which CFPG is able to accommodate.
The medications, vaccines or medical devices being evaluated are generally designed and developed by scientists and medical physicians working with biotechnology and pharmaceutical companies and other health care experts. Every study conducted at CFPG is approved for participation and overseen by the FDA and a central Institutional Review Board (IRB).
Everyone who participates in a study volunteers to so. Volunteers may not receive a study-related treatment or drug as others in the study. Depending on the disease and type of study, you may receive a study drug or treatment, a standard of care study drug or a placebo (an inactive drug treatment). Volunteers, their doctors and research staff may not know which treatment you are getting (this is called a blinded study). Physician and research staff will very closely monitor volunteers during the study.
In addition to FDA oversight, all clinical research studies in the U.S. must be monitored and approved by an independent Institutional Review Board (IRB). This ensures that the risks are the lowest possible and be worth any potential benefits. Doctors, statisticians, patient advocates, statisticians and other members of the community that make up the IRB to make sure the clinical research study is ethical and that volunteers are not likely to be harmed. The IRB can stop a study if:
- It appears medication, vaccine or medical device is causing unexpected harm to volunteers.
- There is evidence that the risks of participation outweigh the benefits for the volunteers.
- There is evidence that the investigational medication, vaccine or medical device is ineffective for the volunteer.
Possible benefits include:
- Access to new medications, vaccines or medical devices that are not yet available to the general public.
- Access to free expert medical care and medications.
- Playing an active role in your own health care.
- Helping others by contributing to medical research.
Possible risks include:
- Unpleasant, serious or even life-threatening side effects from the medication, vaccine or medical device.
- Treatment may not be effective.
- The study will require time for traveling to the medical office.
- The study may involve many visits and various testing.
- There may be unknown risks.
You may stop participation at any time for any reason.
Occasionally, studies may offer modest assistance for participation. This could be in the form of a stipend (a fixed sum to help defray expenses) or compensation to cover expenses such as: mileage, tolls, meals etc. Each study is different. If any assistance is offered, it will be outlined in the study specific informed consent.
Volunteers need to be able to make an informed decision about whether or not to participate. An informed consent includes information but is not limited too;
• The purpose of the study is clearly explained.
• The expected time for participation.
• Description of procedures.
• Disclosure of any anticipated risks.
• Possible discomforts (injections, blood tests etc.)
• Confidentiality of volunteer information.
• How records will be kept.
• Contact information.
Volunteers will be given adequate time to read the document and ask questions about anything they do not understand.
What Are the Types (Phases)?
Scientific researchers first test drugs, vaccines and medical devices in non-humans. This is done to gather information about pharmacokinetics (how an organism affects a drug) and pharmacodynamics (how a drug affects an organism). These tests are done in a laboratory. CFPG does not participate in this type of research.
Phase 0 clinical research is a further exploration of how the body absorbs a medication and how long this medication lasts in the body. There are usually 10 participants in Phase 0 research. The primary purpose is to make sure the treatment is not harmful to humans. CFPG does not participate in this type of research.
Phase I clinical research studies help researchers understand the safety of a medication, vaccine or medical device as well as the best way to administer the medication. There are usually 20-100 participants in a Phase I clinical research study. This type of study lasts from one week to several months. CFPG does participate in this type of research which frequently requires overnight observation.
Phase II clinical research studies help researchers better understand how well a medication, vaccine or medical device may work for the specific condition being studied as well as the side effects that may occur. There are usually several hundred participants in a Phase II clinical research study. This type of study usually lasts from one to two years. CFPG does participate in this type of research.
Phase III clinical research studies help researchers better understand if the medication, vaccine or medical device is safe and effective for the people with a specific condition. There are usually several hundred to several thousand participants in a Phase III clinical research study. This type of study usually lasts from one to four years. CFPG does participate in this type of research.
Phase IV clinical research studies help researchers understand the effects of an approved medication, vaccine or medical device over time. This type of research is done as post-marketing surveillance. There are typically several thousand participants in a Phase IV clinical research study. This type of study usually lasts more than a year. CFPG does participate in this type of research.
Current Clinical Trials
The CFPG Clinical Research department actively participates with national and global FDA approved pharmaceutical studies for the treatment of various lung conditions. Below is a list of medical conditions that may be available for participation.
ARDS is a condition where fluid collects in the lungs’ air sacs, depriving organs of oxygen. It can occur in those who are critically ill or who have significant lung injuries.
AAT deficiency is a rare, inherited disorder that may cause lung and liver disease. When this medical condition affects the lungs, it can cause chronic obstructive pulmonary disease (COPD).
Asbestosis is a long-term inflammation and scarring of the lungs due to exposure to asbestos fibers.
Aspergillosis is an infection, usually of the lungs, caused by the fungus Aspergillus. This fungus causes fungus fibers, blood clots, and white blood cells to form in the lungs or sinuses.
Asthma is a respiratory condition marked by spasms in the bronchi of the lungs, causing difficulty in breathing. It usually results from an allergic reaction or other forms of hypersensitivity.
Bronchiectasis is a condition in which the lungs’ airways become damaged, making it hard to clear mucus. It may result from an infection or medical condition, such as pneumonia or cystic fibrosis. Mucus builds up and breeds bacteria, causing frequent infections.
Bronchitis is an inflammation of the lining of bronchial tubes, which carry air to and from the lungs. Acute bronchitis can be caused by a viral respiratory infection.
Chronic Bronchitis is an inflammation and irritation of the bronchial tubes. These tubes are the airways that carry air to and from the air sacs in the lungs. The irritation of the tubes causes mucus build up.
A chronic cough is when a cough lasts longer than 8 weeks in adults. Common causes include asthma, allergies, bronchitis, or gastro-esophageal reflux disease (GERD).
COPD is a group of lung diseases that block airflow and make it difficult to breathe. Emphysema and chronic bronchitis are the most common conditions that make up COPD.
COVID-19 is a disease caused by a strain of coronavirus. ‘CO’ stands for corona, ‘VI’ for virus, and ‘D’ for Disease. Although most people who have COVID-19 have mild symptoms, COVID-19 can also cause severe illness and even death.
Cystic Fibrosis (CF) is an inherited life-threatening disorder that damages the lungs and digestive system. CF affects the cells that produce mucus, sweat, and digestive juices. It causes these fluids to become thick and sticky. This then plugs up tubes, ducts, and passageways. CFPG is the only center in Central Florida accredited by the Cystic Fibrosis Foundation to treat adults (18 years and older) with Cystic Fibrosis. CFPG participates in a wide variety of CF clinical studies.
EVALI is a severe lung illness associated with using e-cigarette and vaping products.
Emphysema is a lung condition that causes shortness of breath when the air sacs in the lungs (alveoli) are damaged. Over time, the inner walls of the air sacs weaken and rupture creating larger air spaces instead of many small ones.
hMPV can cause upper and lower respiratory disease in people of all ages, especially among young children, older adults, and people with weakened immune systems. hMPV is in the paramyxovirus family of viruses along with respiratory syncytial virus (RSV).
HP is a lung disease which results from breathing in specific environmental allergens causing inflammation of the lung tissue. This inflammation makes breathing difficult. Over time, it can lead to irreversible lung scarring.
IPF is a chronic, progressive lung disease. This condition causes scar tissue (fibrosis) to build up in the lungs, making the lungs unable to effectively transport oxygen into the bloodstream.
Influenza is a common but serious respiratory infection that can be deadly, especially in high-risk groups. The flu attacks the lungs, nose, and throat. People with a weak immune system are at high risk for contracting the flu.
ILD is a group of disorders that cause progressive scarring of the lung tissue. It may be caused by long-term exposure to hazardous materials such as asbestos or coal dust. It can also be caused by autoimmune diseases, such as rheumatoid arthritis. Once lung scarring occurs, it’s generally irreversible.
Lung cancer that begins in the lungs most frequently occurs in people who have smoked or been exposed to second hand smoke, exposure to certain toxins, or family history. Two major types of lung cancer are non-small cell lung cancer and small cell lung cancer.
MAC is a group of bacteria related to tuberculosis. This type of bacteria is very common in food, water, and soil. This group of germs can make people with weaker immune systems very sick. This is a localized infection that can attack the lungs.
Mesothelioma is a tumor of the tissue that lines the lungs, stomach, heart, and other organs. Cancerous (malignant) mesothelioma is the most common form, which usually affects the lungs.
Nontuberculous mycobacteria are tiny germs found in soil, water, and on both tame and wild animals. If contracted, this infection can slowly scar and damage your lungs.
Pneumonia is an infection which inflames air sacs in the lungs causing them to fill with fluid or infection. This infection can be life-threatening particularly to infants, children, and people over 65 years of age.
PAH is a type of high blood pressure that affects arteries in the lungs and right side of the heart. The condition worsens over time, but medications and oxygen therapy can help lessen symptoms and improve quality of life.
PE is a condition in which one or more arteries in the lungs become blocked by a blood clot.
Pulmonary fibrosis is a lung disease that occurs when lung tissue becomes damaged and scarred. This thickened, stiff tissue makes it more difficult for your lungs to work properly.
Pulmonary hypertension is a type of high blood pressure that affects arteries in the lungs and in the heart.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults.
Sarcoidosis is the growth of tiny collections of inflammatory cells in different parts of the body. The growth most commonly occur in the lungs, lymph nodes, eyes, and skin.
SARS is a contagious and sometimes fatal respiratory illness caused by coronavirus. SARS can be transmitted through droplets that enter the air when someone with the disease coughs, sneezes, or talks.
Silicosis is a lung disease that usually happens when you breathe in dust that contains silica. Silica is a tiny crystal found in sand, rock, or mineral ores like quartz. Overtime, silica builds up in your lungs and breathing passages, leading to scars that make breathing difficult.
Sleep apnea is a potentially serious sleep disorder in which breathing repeatedly stops and starts. If you snore loudly and feel tired even after a full night’s sleep, you might have sleep apnea.
Various clinical trials study the negative effects of smoke and/or secondhand smoke on the lungs.
Tuberculosis is a serious, infectious, bacterial disease that mainly affects the lungs. The TB bacteria is spread when an infected person coughs or sneezes.
Further CFPG Information
Please contact our Research Department for more information on any clinical trials you may be interested in participating in. *Compensation may be available for time or travel.
For more information regarding a specific research study, please contact:
Kathleen Summo PhD, MSN, RN, CCP
407.841.1100 ext. 225
Center for Information and Study on Clinical Research Participation: www.searchclinicaltrials.org
Center Watch: www.centerwatch.com
My Clinical Trial Locator: www.myclinicaltrial.com
National Institutes of Health: www.clinicaltrials.gov