We offer...
• Access to New Treatments
• Close Personal Monitoring of
each individuals healthcare
• Possible reimbursement for
time and travel
• Study related medications
and procedures at no cost
to the patient
FREQUENTLY ASKED QUESTIONS
Q. What is a clinical trial or clinical study?
A. A clinical trial is the scientific evaluation of the safety and effectiveness of a new investigational medical treatment, medication or device in human volunteers. After showing considerable benefit in the laboratory, new treatments must be tested among animals and then among small groups of people for safety and effectiveness of the treatment for a specific condition such as diabetes or high blood pressure.
Clinical trials must take place before new research treatments can be made available to the public for prescription or over-the-counter use. Many currently available medical treatments have been analyzed through clinical trials, which are carefully monitored under strict government regulations
Q. Why are clinical trials important?
A. Clinical trials are important to ensure that individuals receive safe and effective treatments for their health conditions.
1.They provide the means to develop new treatments that are as effective, more effective, or safer than treatments already on the market.
2.They allow researchers to discover new indications for approved reasons for using medications already on the market.
3.They make it possible to develop new treatments for conditions that currently have no treatments.
Q. Where are clinical trials performed?
A. Clinical trials are performed around the world. They are conducted in various settings such as doctors offices, research centers and hospitals.
Q. Who sponsors clinical trials?
A. Clinical trials are sponsored by pharmaceutical companies, federal health agencies, medical centers, medical foundations, and universities. We primarily work with pharmaceutical companies.
Q. What are the risks of participating in a clinical trial?
A. There are risks to participating in a clinical trial. Although every effort has been made to determine the risks during pre-clinical and early clinical studies, there may be side effects and other health risks that are as of yet unknown. Side effects differ from one person to another, and there is no way to predict how the treatment will affect any given individual. Some of the risks are that participants may not receive active treatment for their condition and/or the study treatment may not be effective. Trials sometimes require washout periods when subjects have to go off all active treatments for a period of time. The reasonably foreseeable risks of a study are listed in the informed consent form.
Q. What are the benefits of participating in a clinical trial?
A. People participate in clinical trials for various reasons, including health, financial and personal needs. Volunteers who participate in clinical trials help to further advance medical science, which may help others in the future. While there are no guarantees that participants will benefit from the research treatment they receive, some may find that the study medication relieves their condition more effectively and/or with fewer side effects than their previous treatment plan. Clinical trials sponsored by pharmaceutical companies provide the study medication and study-related care. In addition, financial compensation for time and travel expenses may be provided to study participants in some clinical trials.
A. A placebo is an inactive substance that may be given to a percentage of the study participants in a clinical trial to assist in evaluating the effects of the active study treatment.
A. Informed consent is the process by which a potential study participant is provided with information about the study and treatment before deciding whether or not to participate in the trial. It includes an explanation of what is involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment.
Participation in clinical trials is completely voluntary. All questions about the study should be answered to the patients satisfaction before an informed consent form is signed. Patients have the right to refuse participation or to withdraw their consent at any time during the study without penalty. The best interest of the patient is considered at all times throughout the trial. Participants will be provided with any new information that may affect their decision to continue their participation in the study. Also, the study physician may withdraw a patient at any time if it becomes evident that the treatment is not in the patients best interest.
Q. What are the study participant's responsibilities?
A. In the interest of safety, the participants must fully inform the study physician about past and current medical conditions, illnesses and medications. They must follow the prescribed treatment plan and attend the scheduled visits. Other study-specific responsibilities will be explained by study personnel.
Q. What protection does a patient have as a participant in a clinical trial.
A. Clinical trials are governed by clearly defined ethical and legal codes. In 1981 regulations of the FDA made it a requirement that all federally regulated clinical trials be reviewed and approved by an Institutional Review Board (IRB) before and during the course of the trial. An IRB is a committee of volunteers including experts and lay people such as doctors, scientists, clergy, and other community members. Their primary goals are to protect the public, to evaluate whether the potential benefits of study participation outweigh the risks, and to ensure that patients are not coerced into participating in a clinical trial.
Study plans and the progress of clinical trials are reviewed periodically by the IRB as well as by the study sponsor and the investigator. The FDA and other federal agencies such as the National Institute of Health oversee the institutional review boards.
Ongoing changes to clinical trial regulations and the review process help to ensure that the rights and the welfare of the study participants are protected more thoroughly than in past years.
Patients may call the IRB with questions about their rights as a research participant. The name and telephone number of the IRB overseeing the clinical trial is included in the informed consent form.
Q. Is a patient's study participation and medical information kept confidential?
A. Patient confidentiality is maintained as much as possible during and after a clinical trial. Outside of the research team, a participant's name may not be disclosed without permission of the participant unless required by law. Generally, the sponsor, FDA, and the IRB have access to the study patient's medical records. To ensure confidentiality, volunteers are assigned a patient number once they are enrolled in a trial and are identified by this number and their initials for the duration of the study.
Q. How does a person become involved in a clinical trial?
A. There are many ways to find out about clinical trials, including advertising, listing on the internet, mailings, word of mouth, health fairs, and physician referrals. Individuals looking for clinical trials for a specific condition should discuss the available options with their physician. The majority of our study subjects are from referrals within our family practice, FPA Family Health Care.
Q. Are patients required to pay for participation in a clinical trial?
A. There is no cost for joining a clinical trial. Study medication as well as study-related tests and procedures are usually provided at no charge to study participants. It is important to ask the research staff to explain exactly what charges, if any, may be the responsibility of the study participant.
Q. What questions should you ask before deciding to participate in a clinical trial?
A. 1. Why is the clinical trial being conducted?
2. What type of treatment is being studied?
3. What are the known side effects of the study treatment?
4. How long is the study?
5. How often and when will I be expected to come in for visits?
6. How long will each visit last?
7. How often, when, and how does the study treatment have to be taken?
8 When should I call the doctor?
9. Who do I contact in case of an emergency?
10. Can I continue my current medications?
11. What medications do I need to avoid?
12. Should I avoid alcohol, specific foods or other agents?
13 What procedures are required during the study?
14. What effects should I expect from these procedures?
15. What other treatment options are available to me, and what advantages or disadvantages could expect from them?
16. Will I be responsible for the cost of any of any of the visits, medications, or procedures performed during the trial?
17. Will my own physician be notified about my participation in the trial?
18. How will my study participation affect my daily life?
For any additional information please call us at 321-402-0100.