Frequently Asked Questions

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  • What is clinical research? Clinical research is the process that all medications go through in order to be prescribed. It is an extensive investigative process that collects the data necessary for new medications to be approved by the FDA for use in the United States.

  • Who can be involved in Clinical Studies? Each study has its own set of patient requirements, but any patient who needs treatment or is currently being treated for common medical conditions can be screened and considered for inclusion in a study.

  • 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 and/or Rheumatoid Arthritis

  • Psoriasis and other Dermatologic Conditions

  • Pain associated with Diabetic Neuropathy

  • Post Herpetic Neuralgia

  • Type 2 Diabetes Mellitus (oral as well as injectable medications)

  • High Cholesterol

  • Hypertension

  • Irritable Bowel Syndrome

  • Constipation

  • Chronic Obstructive Pulmonary Disease (COPD)

  • Bronchitis

  • Asthma

  • Impetigo and other wound infections

  • Acute Infections

  • 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 visits and the number of visits varies study to study.

  • Who determines how many patient visits there will be and how long the study will last? Each new study has its own 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 the FDA as well as an outside agency called an Institutional Review Board.

  • What is the Institutional Review Board (IRB)? The Institutional Review Board is an outside agency not affiliated with any pharmaceutical company, the FDA or individual research sites. They are a committee whose job is to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.

  • What are the different phases of clinical trials? Phase I trials test new investigational products in small groups of humans for the first time. The purpose of these trials is to determine the safety of the investigational product, begin to develop safe dosage ranges for the product and to begin to identify what side effects the potential medication may have.

     Phase II trials test investigational products that still have not been approved by the FDA to be marketed in the        United States. These trials enroll larger numbers of people than a Phase I trial. This phase of research is                  designed to evaluate the effectiveness of the investigational product and to continue to evaluate its safety.

     

     Phase III trials are conducted in large groups of people to confirm the overall effectiveness of the investigational      product,  monitor the side effects and to evaluate its use as compared to currently established medication              treatments.

     Phase IV trials are conducted after the medication has been FDA approved and has become available on the            market. These types of trials gather data on the effects associated with long-term use of the medication, or to          determine additional uses for the medications that weren’t previously studied. They are also conducted to                further evaluate the medication in other populations not previously studied.

  • Who pays for the research? Research is supported by grants from pharmaceutical companies who have developed new compounds or who are testing previously approved drugs for long term safety or news therapeutic indications or uses.

  • What is a placebo? A placebo is a product that visually resembles the investigational product 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 investigational product. 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 investigational product they are developing.

  • Do all studies use a placebo? Not all studies utilize placebos in their design; some sponsor companies develop protocols that compare their investigational product to medications already on the market that would be their competitor.

  • 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 investigational product 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 and research physician 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 any questions answered that you may have.

  • Will I have to pay for any of the medicines, visits, labs or other procedures? No, there are no out of pocket expenses that you would be required to pay. All study medicines, medical visits, labs and any other procedure associated with the study are at no charge to patients that qualify for study enrollment.

  • 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.

  • 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.

  • 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.

  • 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 and what it means to be enrolled in a clinical study.

  • After I complete a study, can I enroll in another one? Yes, you can be considered for another study once you have completed the first one. However, there is a mandatory minimum waiting period of 30 days 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 all research facilities.

©2017-2019 by The Chappel Group Research. All rights reserved.

601 East Oak Street Suite A 

Kissimmee, Florida 34744

(321) 337-0700 ext. 903

(407) 201-3965 - Fax

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