QUESTIONS & ANSWERS

 

 

1. What are Clinical Trials?
2. Why should I participate in a Clinical Trial?
3. What safeguards are in place to protect me?
4. Is my participation confidential?
5. What will it cost me to participate in a Clinical Trial?
6. Will I be compensated for participating in a Clinical Trial?
7. How long does each office visit last?
8. How long do the studies last?
9. Who would be diagnosing me or giving me medical advice?
10. What Can I expect from the Clinical Trial Team?
11. Who decides if I am eligible for a Clinical Trial?
12. Who decides what intervention I will get during a Clinical Trial?
13. What are the phases of Clinical Trials?
14. What happens if I want to leave a Clinical Trial?
15. Can I be forced to leave a Clinical Trial?

 

 

 

 

1. What are Clinical Trials? (back to top)

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Clinical trials are research studies that test new interventions in people. An intervention can be a drug, a device such as a pacemaker, a diagnostic tool, a genetic test, or even a new way to prevent disease or offer support for sick people. In some cases, clinical trials test new uses for existing medications. Clinical trials also test new therapeutic options for existing drugs – for example, once-a-week dose instead of a daily dose or an inhaled medication instead of an injection. Researchers use clinical trials to find out whether an intervention is safe and whether it is effective. Clinical trials are required by law and closely regulated. The Food and Drug Administration (FDA) require companies to show that new medical products are both safe and effective before approving them. Clinical trials are the best way to prove that new medications, practices, or devices are safe and effective.

 

 

2. Why should I participate in a Clinical Trial? (back to top)

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There are two reasons why you may want to participate in a clinical trial: 1) to help yourself and, 2) to help others.

 

1. It is possible that any treatment being tested will improve your health or condition. You will certainly receive a very thorough evaluation of your condition throughout your trial, including many laboratory and other tests, and you will be given your diagnosis and an explanation of it.
   
   
2. You may also decide to participate in a clinical trial for the satisfaction that comes from being part of a scientific research study that might help others. Every day there are people hoping for a breakthrough treatment that will make coping with their condition easier or even cure it altogether. Clinical trial volunteers help make those discoveries available to people throughout the country and possibly around the world. Your participation might be crucial to helping others cope with the condition.

 

 

3. What safeguards are in place to protect me? (back to top)

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By federal law, researchers must take several steps to make clinical trials as safe as possible. These include:

 

• A written examination about the content of clinical research and the ethical responsibility of the researchers.
• Preclinical studies that show that a new treatment is safe and effective in laboratory animal tests.
• Use of strict protocol – an outline prepared before the beginning of a study that describes exactly what will take place during the trial.
• A written description of all the information that you will need to make an informed decision about joining a clinical trial. The process of giving you this information is called an informed consent.
• Approval of the trial by an Institutional Review Board (IRB) – an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. The IRB board must approve all clinical trials before they begin and at least once every year after. They also evaluate the merits of a trial and ensure that the clinical trial poses no unnecessary or inappropriate risks.

 

 

4. Is my participation confidential? (back to top)

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Yes. All information including medical, history of illness, personal and any information obtained during the study is confidential and protected by State and Federal regulations governing clinical research. We will not release your personal information to anyone without you specifically authorizing us to do so.

 

 

5. What will it cost me to participate in a Clinical Trial? (back to top)

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Nothing. All medical care, including tests and medications related to the clinical trial are provided, at no charge.

 

 

6. Will I be compensated for participating in a Clinical Trial? (back to top)

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Yes. In nearly all of our trials, we will reimburse you a flat fee for your travel expense for each office visit.

 

 

7. How long does each office visit last? (back to top)

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The time for each visit can vary. The initial visit is usually at least 2-3 hours due to the comprehensiveness and thoroughness of our initial assessment. Most visits after that are at least 45 – 60 minutes in duration.

 

 

8. How long do the studies last? (back to top)

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Each clinical trial is different. Upon qualification into the study, this information would be provided to you.

 

 

9. Who would be diagnosing me or giving me medical advice? (back to top)

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We have an excellent staff with a wealth of experience, knowledge and familiarity in clinical research, however, only one of our doctors can diagnose or give medical advice.

 

 

10. What Can I expect from the Clinical Trial Team? (back to top)

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You can expect to be given a very thorough explanation about the clinical trial and to have all your questions answered by the study doctor and his staff. You will be given an informed consent form to read and sign. This is required by law to make sure you understand what is involved in the trial. The consent form will include a discussion of the potential risks and benefits, and will have information about the schedule and duration of the trial, and the name of the study doctor who you can call with questions or problems. You can also expect to have an evaluation of your condition and to be given the diagnosis by the study doctor.

 

 

11. Who decides if I am eligible for a Clinical Trial? (back to top)

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Researchers must make two types of decisions about whom they study for a clinical trial, inclusion criteria and exclusion criteria.

 

Inclusion criteria are those characteristics that everyone must have to join the trial. For example, in a study of a medication for people with diabetes, all study participants need to have diabetes.

 

Exclusion criteria are those characteristics that people cannot have if they want to participate in the study. For instance, in a study of medication to prevent heart attacks, people who have already had a heart attack might be excluded.

 

 

12. Who decides what intervention I will get during a Clinical Trial? (back to top)

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Many clinical trials test a new drug against a placebo, which looks just like the drug but doesn’t contain any active ingredients (like a sugar pill). Other clinical trials test two different drugs to determine which is more effective. If it is a randomized trial, participants are randomly assigned by computer to the drug or the placebo. Because researchers have no say in the decision, the process is fair for everyone. However, randomization also means the researchers cannot guarantee what you will get if you enter the trial.

 

Some trials compare different drugs or different doses to learn which is most effective. The study participants are randomly assigned to one drug and do not know which medication they are taking.

 

 

13. What are the phases of Clinical Trials? (back to top)

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Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.

 

Phase I:

 

Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.

 

Phase II:

 

The study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

 

Phase III:

 

The study drug or treatment is given to large groups of people (1000-3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

 

Phase IV:

 

Post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

 

 

14. What happens if I want to leave a Clinical Trial? (back to top)

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An important safeguard in a clinical trial is your freedom to leave. You can leave a clinical trial at any time for any reason. The informed consent document that you sign does not force you to remain in a trial. Clinical trials may offer you suggestions about how to leave the trial, particularly if the trial medication needs to be withdrawn gradually, but you have the final decision. If you leave a clinical trial, it may be helpful to let the researchers know why you are leaving, but this is not required. This information may help researchers improve the clinical trial process for other participants and may make the results of the trial more reliable.

 

 

15. Can I be forced to leave a Clinical Trial? (back to top)

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Without trial participants, clinical trials fail and medical science suffers. For these reasons, researchers generally make great efforts to help you complete clinical trials. Occasionally, researchers must end your participation in a clinical trial for other reasons, which may include:

 

• Changes in your health that disqualify you, based on the study’s inclusion and exclusion criteria.
• Changes in your health that makes the study more risky or dangerous.
• A sponsor ends the clinical trial.
• Researchers learn new medical information that makes the study unnecessary.