1. Who is FPA Clinical Research?
We are an independent company specializing in the investigation of compounds being developed to treat, control or cure a variety of disease processes. We participate in FDA approved studies in partnership with many leading pharmaceutical companies.
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2. What is clinical research?
Clinical research is the process that all medications go through in order to be prescribed. It is an extensive testing process under the direction of the FDA performed at licensed and regulated research sites like FPA Clinical Research.
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3. Who can be involved in Clinical Studies?
Each study has its own set of patient requirements, but any patient who is currently being treated for common medical conditions can be screened for a study.
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4. What are some of the conditions that you are currently studying medications for?
Currently we have studies that are enrolling patients in a wide variety of areas. We routinely have studies for these common disease states:
- Chronic Pain
- Osteoarthritis
- Rheumatoid Arthritis
- Pain associated with Diabetic Neuropathy
- Post Herpetic Neuralgia (pain associated with Shingles)
- Type 2 Diabetes Mellitus (oral as well as injectable medications)
- High Cholesterol
- Hypertension
- Cardiovascular Risk assessment for prevention of heart attacks and stroke
- Atrial Fibrillation
- Insomnia
- Bronchitis
- Impetigo and wound infections
- Sinusitis
- Pneumonia
- Asthma
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5. How long do the studies last?
Studies can last anywhere from 1 week to 1 year or beyond. Each study has its own schedule of patient’s visits and the number of visits varies study to study.
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6. Who determines how many patient visits there will be and how long the study will last?
Each new study has its own FDA approved protocol; which is a very detailed publication that defines all aspects of the study, including the number of visits and the length of the study. The protocol is developed by the pharmaceutical company that is sponsoring the study and is approved by an outside agency called an Investigational Review Board, as well as the FDA.
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7. What is the Investigational Review Board (IRB)?
The IRB is an outside agency that oversees all aspects of a study, insuring that patient safety and confidentiality is protected throughout the course of the study.
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8. Are Research Compounds Safe?
Some of the compounds that we study have already been approved by the FDA and are currently being prescribed by doctors around the world. If a study compound is a new one that is not currently available, it has already gone through extensive initial testing in animals and humans in what is called a Phase 1 study, Phase II thru IV trials are designed to continue testing the safety and effectiveness of the new compounds.
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9. What are the different phases of clinical trials?
Phase I trials test new compounds in small groups of humans for the first time. The purpose of these trials if to determine the safety of a compound, the safe dosage ranges and to begin to identify what side effects the compound may have.
Phase II trials test compounds that still have not been brought to market. They are completed in larger groups of people than a Phase I trial to evaluate its effectiveness, it’s dosing and to continue to evaluate the safety of the compound.
Phase III trials are conducted in large groups of people to confirm the overall effectiveness of the compounds, monitor the side effects and evaluate its use compared to currently established treatments.
Phase IV trials are conducted after the compound has been FDA approved and have become available on the market. These types of trials gather data on the effects associated with long-term use, or to determine additional uses for the compounds that weren’t previously studied. They are also conducted to further evaluate the compound in other types of populations not previously studied.
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10. Who pays for the research?
Research is supported by grants from pharmaceutical companies.
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11. What is a placebo?
A placebo is a product that visually resembles the compound being studied, but is often inactive. Some studies are designed to have 1 group of participants take a placebo and 1 group take the active study compound. It is in this way that the sponsor company can compare the results of both groups and get a better overall idea of the effectiveness of the study compounds.
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12. Do all studies use a placebo?
Not all studies utilize placebos in their design; some sponsor companies develop studies that compare their study compound to products already on the market.
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13. What is Informed Consent?
It is important that you, as a study participant, understand everything about the study you are considering entering and what your involvement will be within the study. Every study has an Informed Consent Form (ICF), which contains all the details about the study. It is from this ICF that you will learn about the purpose of the study, the compounds being studied, the length of the study as well as the number of patient visits you will be required to attend. Additionally, you will be told about the procedures that will occur during the visits as well as some of the potential risks or side effects that may be encountered during the course of the study. Your study coordinator will go over all the details with you as outlined on the ICF and then have you initial each page and sign the completed form once you have had time to read it and have had all of your questions answered.
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14. Will I have to pay for any of the medicines, visits, labs or other services?
No, there are no out of pocket expenses that you would be required to pay. All study medicines, medical visits, labs and any other service associated with the study are at no charge to qualified patients.
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15. Can I be reimbursed for my travel?
Many studies reimburse patients for time and travel. The amount reimbursed varies from study to study, but your study coordinator can give you specifics for your particular study.
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16. Will I receive any testing supplies, like for my diabetes?
Many of the Diabetes studies supply glucose monitors and the supplies that go with them for the patients that enroll in their particular studies. The patients in those studies use the monitors and supplies throughout the study and then they keep them for their personal use once the study is completed.
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17. Are there age requirements to enroll in a study?
Each study has its own age requirements that have been set by the sponsor company and are listed in the FDA approved protocol. All studies vary in the ages that they will allow to enroll in the study. Your age will be one piece of information that your study coordinator will ask you when evaluating you for enrollment into a study.
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18. Can I refer family or friends?
Yes you can refer your family and friends to us. We really appreciate our current patients bringing in their friends and family so that we have the opportunity to show them what research is all about.
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19. After I complete a study, can I enroll in another one?
Yes you can screen for another study once you have completed the first one. However, there is a mandatory 30 day waiting period that you will have to complete before you will be eligible to be evaluated for another study. This is a requirement from the FDA and applies to all research studies and facilities.
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