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Frequently Asked Questions
All clinical trials are based on a set of rules and action plan called a protocol. The study's principal investigator follows a protocol for the study. A protocol describes what types of patients may be eligible for the trial, the schedule of tests, procedures, medications and dosages, and the length of the study. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
The government has strict guidelines and safeguards in place to protect people who volunteer to participate in a clinical trial. In the United States, each clinical trial must be approved and monitored by a local Institutional Review Board (IRB) to ensure the risks to the study participants are as low as possible. An IRB is an independent committee of physicians, statisticians, and community advocates, among others, that ensure a clinical trial is ethical and the rights of research volunteers are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Clinical trials may be sponsored by a government agency, a pharmaceutical company, an individual physician, a healthcare organization, a university, an organization that creates medical devices, or a physician's office. In some instances, additional testing or physician visits may be required. The cost of these extra tests may be covered by the study, although you or your insurance company may ultimately be responsible for the additional costs incurred. Information regarding this topic will be outlined in the research volunteer's Informed Consent.
Clinical trials are used to study many aspects of medical care, including:
•Treatment trials: These focus on testing new drugs or surgical procedures;
•Prevention trials: These test a variety of ways people can prevent disease;
•Diagnostic trials: Look for better procedures to diagnose a disease or condition;
•Screening trials: Test the best way to detect a health condition or a disease; and
•Quality of life trials: Investigate ways to improve the quality of life for people living with a chronic illness.
A placebo is designed to resemble the treatment under investigation through a clinical trial. The exception is that the placebo is inactive. An example of a placebo is a pill containing sugar instead of the drug being studied. By giving one group of participants a placebo and the other group the active treatment, the researchers can compare how the two groups respond and get a truer picture of the active treatment's effects.
A control group is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug, while the control group is given either a standard treatment.
Side effects are any undesired actions or effects as a result of taking a drug or undergoing a treatment. Negative or adverse side effects may include headache, nausea, hair loss, skin irritation or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
It is important for research volunteers to understand the general principles that apply to anyone taking part in the study:
•Participation is entirely voluntary;
•While you may or may not experience personal benefits as a result of taking part in the study, knowledge may be gained from your participation that may benefit others; and
•At any time, patients may decide to discontinue their participation without any negative consequences.
An Institutional Review Board (IRB) is a committee charged with protecting the rights and welfare of people participating in research activities. The IRB reviews and approves research applications involving human subjects, provides ongoing oversight to ensure regulatory compliance, and assures that the risks to research subjects are minimized and participation by these subjects is done so on a voluntary, informed basis. Both the Food and Drug Administration and the Office for Human Research Protections set the guidelines and regulations governing human subjects research and establish the authority granted to the IRB. The IRB highly encourages all investigators, coordinators, sponsors and research volunteers to contact the IRB for questions, advice or concerns at any time. Any questions, concerns or suggestions will be responded to in a confidential and professional manner.
There are four phases of a clinical trial:
Phase I: In this phase, it is usually the first time a new treatment, drug or device is used in humans. The treatment under investigation is given to a small number of research volunteers at a very low dose or setting, and is increased over time according to the response. The purpose of this phase is to determine the best way to give the new treatment - either by mouth, injected into the blood or injected into the muscle - and how much of it can be given safely.
Phase II: Phase II helps to determine the effect of a research treatment on a particular disease or condition. Phase II trials involve the development of a protocol, or plan, about how the trial will be conducted and how the data will be analyzed. These plans are submitted to the Institutional Review Board (IRB), who must approve the protocol before the clinical trial begins. The IRB is a group of health professionals and non-medical persons whose job it is to review and monitor clinical research to protect the safety and rights of participants. Some research is also reviewed and monitored by federal agencies, such as the National Institutes of Health or the Food and Drug Administration. In a Phase II clinical trial, there may or may not be a control group. Control groups receive standard, current care. Treatment groups receive the experimental therapy.
Phase III: This phase compares the new treatment with the standard treatment on a larger group of research volunteers to determine effectiveness, dosing, and optimal characteristics of a treatment, drug or device. The same review and approval process takes place as in a Phase II clinical trial. In this phase, there is most likely a control group and a treatment group. Research volunteers are randomized, or assigned to a group based on chance.
Phase IV: This phase of research is conducted after approval has been given by the Food and Drug Administration. The purpose of a Phase IV clinical trial is to continue testing the study drug or treatment to collect information about its side effects in various populations and any side effects associated with long-term use.