Frequently Asked Questions
Can you tell me about Clinical Trials in general?
Medications must be carefully tested through medical research studies before pharmaceutical companies are allowed to sell them to the public. If studies demonstrate a medication’s safety and effectiveness (how well it works), the pharmaceutical company can then apply for approval to market its medication to the public.
The researchers conducting this study are required to follow a detailed plan called a protocol, which explains all study procedures. This protocol is approved by an independent board and is designed to help protect the safety of all study volunteers. Additionally, researchers must provide potential participants with complete answers to any questions they have about the study.
Medical research studies are necessary to test and, ultimately, develop potential treatments for those in the future with a wide variety of medical conditions. Your participation in this study may help researchers to come up with new tests or medications to help others. However, your participation is voluntary, and you may leave the study at any time, for any reason.
What is a clinical investigator?
A clinical investigator is a medical researcher conducting a research study. Researchers are usually doctors, nurses, pharmacists, or other medical professionals.
Are Clinical Trials Safe?
Clinical studies are typically monitored by a trained medical professional. An Institutional Review Board or IRB reviews all clinical studies. This is a committee made up of doctors, ethicists, and members of the public and administrators. This group helps to ensure that a study may not represent an unreasonable risk to individuals who are participating.
Your doctor is responsible for your well-being and you may want to speak with him/her before agreeing to participate in a study. Whenever you agree to enter a study, you are given contact information for your study doctor's office for any study related questions you may have. You will also be given contact information for the IRB if you have questions about what it means to be in a research study.
Why do people participate in research studies?
There are many reasons people take part in research studies. It gives individuals a chance to receive investigational medication not available to the public. If this is the case, remember the study is being performed to test if the investigational medication works and to see if it is safe.
Often the process of collecting information in the study will allow your doctor to find out more about your disease and the effects it has on you. This may allow you to benefit from better treatment after you have completed a trial.
Lastly, a study may not benefit you directly, but the information gathered may be of help to other individuals in the future with the same condition. Many study participants derive satisfaction knowing they may be a part of the effort to potentially reduce the suffering of other people in the future.
How will I know if I am eligible for a trial?
You can find out about clinical studies from many sources. There are often advertisements in your doctor's office. Many clinical studies are posted on Internet pages such as this one and provide an excellent source of information. Each study has certain requirements for participation. For this study, you must be able to attend all study visits, and take your investigational medication as instructed. Your study personnel will ask about your medical history and may request additional testing to determine if you are eligible according to the criteria for the study. You can call click here to find out if you qualify for Digestive Health Center's latests clinical trial.
Can you explain informed consent to me?
Absolutely. Anyone entering a clinical study in the United States is required to sign an informed consent document indicating that they understand what will happen to them during the study. This document will tell you what investigational medication will be given, what kind of problems might occur, and what other medications might work for your condition. The benefits expected from the study will be given. The informed consent document also indicates which costs are covered by the study and which must be paid by you (or your insurance). In most cases the pharmaceutical company will cover the costs of the visit, medication, and even reimburse travel.
What is a PHASE in a clinical trial?
Most clinical studies are carried out in steps called phases. Each phase is designed to find different information. Prior to entering the phases of human clinical studies, the investigational medication goes through extensive preclinical study testing on animals to justify clinical studies. Participants may be eligible for studies in different phases depending on their general condition, the type and stage of their condition, and what therapy, if any, they have already had. Participants are seen regularly to determine the effect of the investigational medication, and the investigational medication is typically stopped if side effects become too severe. (See the phase descriptions below).
Phase I studies are primarily concerned with assessing the investigational medication's safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study.
The study is designed to determine what happens to the investigational medication in the human body--how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of investigational medications pass this initial phase of testing.
Once a medication has been shown to be safe, it must be tested for effectiveness. This second phase of testing may last from several months to years and involves up to several hundred participants. Most phase II studies are randomized. One group of participants will receive the investigational medication while a second "control" group will receive a standard treatment or placebo (an inactive look alike substance). Often these studies are "blinded"--neither the participants nor the researchers know who is getting the investigational medication. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new investigational medication and its effectiveness. Only about one-third of investigational medications successfully complete both phase I and phase II studies. Safety continues to be evaluated.
In a phase III study, an investigational medication is tested in several hundred to several thousand participants. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the investigational medication's safety, effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded studies. Phase III studies typically last several years. Seventy to 90 percent of investigational medications that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval for marketing the investigational medication.
In late phase III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare an investigational medication with other medications already in the market; (2) studies are often designed to monitor a study medication's long-term safety, effectiveness and impact on a participant's quality of life; and (3) many studies are designed to determine the costeffectiveness of a medication therapy relative to other traditional and new therapies.
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