Frequently Asked Questions and Answers
Below are some commonly asked questions about what we do and how we help.
1What is clinical research?
Clinical research is research conducted with human subjects, or material (specimens, bodily fluids or tissue) of human origin, in which the researcher directly interacts with human subjects. Clinical research helps doctors and researchers to find new and better ways to understand, detect, control, and treat illness. A clinical research study is a way to find answers to difficult scientific or health questions. For example, a study of preterm labor might evaluate which pregnant women are most likely to experience this condition or might evaluate the best treatments for those women who do.
2What is a clinical trial?
A “clinical trial” involves testing a treatment to determine if works and is safe. Usually this means testing a drug or medical device to see if it works and is safe in the treatment of a specific disease. For example, a clinical trial may test the effectiveness of a new drug for treating Parkinson's disease. This same principle applies to other kinds of treatments/testing including counseling programs and many kinds of laboratory tests. Many new medicines and drugs are found to work in the researcher's lab, and to be safe and effective in animal tests. But drugs and devices must be proven to be safe and effective for people before the Food and Drug Administration (FDA) can approve them and doctors can prescribe them to patients. The FDA has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.
3Why should I volunteer in a clinical research?
Clinical research is a vital part of finding new treatments and cures for diseases. It is also vital to our ability to detect problems before they occur. In cancer research some of the biggest achievements have been in those cancers that we can detect early and conversely those we don’t detect early are often fatal when they are detected. Similarly, there are many obstetrical compilations that we are still are not able to detect early in pregnancy and as a result do a poor job in treating. Carefully conducted clinical studies are the fastest way to find the best detection methods and the best treatments that are safe and effective. By volunteering for a clinical study, you WILL be participating in research that improves our understanding of the disease. This will lead to new detection methods or better treatments or both. Before you agree to participate in a study, you must be given complete information about the study, known as "informed consent." Informed consent involves two essential components: a document and a process. The informed consent document gives a summary of the research project (including the study's purpose, research procedures, potential benefits and risks, etc.) and explains the individual's rights as a research participant. This document is part of an informed consent process, which consists of conversations between the research team and the participant, and may include other supporting material such as study brochures. The informed consent process provides research participants with ongoing explanations that will help them make informed decisions about whether to begin or continue participating in the research project. The Food and Drug Administration (FDA) provides details about informed consent with the information page: fda.gov (Clinical Trials of Medical Treatments: Why Volunteer?).
4How will I be protected and is my information confidential?
Clinical trial studies are designed to ensure that volunteers are not placed at undue risk. Before the study can begin, an Institutional Review Board (IRB) comprised of a diverse group of physicians, nurses, pharmacologists and community representatives carefully reviews all study related materials. As a volunteer, you have the right to refuse treatment at any point in the clinical trial and leave at any time and for any reason. All of the clinical trials that WOMB is conducting are done in accordance with Good Clinical Practices and Federal Regulations. WOMB staff is required to keep all study patient records confidential. The consent form that you signed prior to participation specifies who has access to your record. Generally this includes the FDA and its employees, other government authorities, the sponsoring company and their representatives, WOMB research staff, and the IRB. Any of these parties may review the study patient’s record and information collected during the study.
5Who will be monitoring my care if I decide to participate in a study with WOMB?
The Principal Investigator or Sub-Investigators, who are physicians, will be monitoring your care. These physicians are highly trained doctors who have knowledge and training in obstetrics and high-risk pregnancies. The physicians work very closely with research coordinators, who follow the protocol under the guidance of the Principal Investigator. They have a high level of expertise and devote a great deal of time to the planning and conduct of the research study. They will assist you throughout the study during the consenting process, delivering the treatment whether that be a drug, device or something else, performing the study visits, and answering any questions you may have. An experienced research nurse is a valuable source of knowledge and guidance for patients.
6What will occur while I participate in the study?
The study procedures and process will vary depending on the type of clinical trial you participate in. Before you begin a study, the process and all procedures for that study will be explained to you. Throughout the study, the research nurse and the Principal Investigator will assist you and can answer any questions you have. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study. Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. Your participation will be most successful if you carefully follow all instructions you are given and stay in contact with the research staff.
7What are the risks of participating in a clinical trial?
It is possible that you develop side effects and/or other health risks and often may not develop any side effects. Side effects and health risks vary from patient to patient. The number of side effects, if any, you experience will depend on the type of treatment being studied and your medical condition. Because clinical trials evaluate new medical treatments, the risks of the treatments are not always known ahead of time. However, in every study several safeguards are put in place to protect the safety of the participants. Before you agree to participate in a study, it is important that you know what side effects may occur and, as much as possible, what unknown side effects or risks may occur. This information will be covered thoroughly during the informed consent process before you enroll in the study.
8I have heard that clinical trials have different phases. What does that mean?
Most clinical research that involves the testing of a new drug has an orderly series of steps. This allows researchers to ask and answer questions in a way that expands our information about the drug and its effects on people. Based on what is learned in laboratory experiments or previous trials, researchers formulate hypotheses or questions that need to be answered. Then they carefully design a clinical research study to test the hypothesis and answer the research question. It is customary to separate different kinds of trials into phases that follow one another in an orderly sequence. For instance, cancer clinical research generally falls into one of three phases. • Phase I Trials: These first studies in people evaluate how a new drug should be administered (orally, intravenously, by injection), how often, and in what dosage. A Phase I trial usually enrolls only a small number of participants. • Phase II Trials: A phase II trial provides preliminary information about how well the new drug works and generates more information about safety and benefit. Each Phase II study usually focuses on a particular type of cancer, for example. • Phase III Trials: These trials compare a promising new drug, combination of drugs, or procedure with current, standard therapy. Phase III trials typically involve large numbers of people in doctors' offices, clinics, and cancer centers nationwide. If you participate in a Phase III treatment trial, you are likely to be randomized (assigned by chance) to a group receiving either the new intervention or the standard intervention. Trials designed in this way are also called randomized controlled trials. If you are assigned the standard intervention, you receive what experts view as the best treatment available in the realm of routine medical practice. If you are assigned the new intervention, you receive a treatment that some experts think may have significant advantages over the standard. The reason that the clinical trial has been started is that the superiority of one treatment over the other has not yet been firmly established.
9What if I change my mind about participating in the research that is already underway?
You can change your mind and leave the study at any point while on the study, before the study starts or at any time during the study or follow up period. Remember that participating in research is always voluntary. Even if you decide to participate in a study, you can always withdraw from the study without it affecting the relationship with the research staff or your health care provider.
10Will there be any cost to me for participating in the study?
There is usually no cost to you for taking part in a research study. The clinic visits, tests and surgical procedures that are done as part of the research study will be provided at no cost.
11Will I be compensated for participating in the study?
Depending on the study there may be some compensation (monetary or gift) available for participating. Generally as a participant you are receiving novel testing or a new treatment at no cost to you, which could be perceived as a benefit. Because the benefit has not been proven it is still uncertain at the time of study participation. There is often other specific monetary compensation available for the added time, effort, discomfort and travel demanded by the study. The specific amount is defined in each study consent form, which has always been reviewed by the applicable IRB to ensure that is not coercive.
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