A clinical trial could be a treatment option for you. The goal of research is to find better ways to treat or identify cancer and help cancer patients. Clinical trials test many types of treatment, such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy.
Some clinical trials study the effects of our standard treatments on patient quality of life during and after completion of the treatment. The knowledge that may be gained from this type of work can be of great value to our society.
To ensure the safety of volunteers who enroll in clinical studies, each project must be approved by an Institutional Review Board IRB. The goal of the IRB is to ensure safety, welfare and well-being of study participants. During the review process, the IRB evaluates the potential risks and benefits associated with the study and decide whether or not to approve it. A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments.
Clinical trials also called medical research and research studies are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.
Ideas for clinical trials usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning Phase I clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results. All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in 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 to protect people who choose to participate in clinical trials. Every clinical trial in the U. An IRB is 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.
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. Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:.
If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. If English is not your native language, you can ask for the consent documents in languages other than English. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision.
It is also a good idea to take the consent documents home and discuss them with family members or friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join the clinical trial, be sure to ask for a copy of the informed consent documents so you can review them at any time. Remember informed consent is more than signing a form. It is a process that continues through the study. You should feel free to ask the research team questions before, during, and after the study.
Informed consent continues as long as you are in the study. All clinical trials have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition.
Before you join a clinical trial, you must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Healthy volunteers participate in Phase I trials, vaccine studies, and trials on research on preventive care for children or adults. The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria.
It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
Clinical trials are sponsored by government agencies: such as the National Institutes of Health NIH ; pharmaceutical companies; individual physician- investigators; health care institutions such as health maintenance organizations HMOs ; and organizations that develop medical devices or equipment.
The clinical trial process depends on the kind of trial you participate in. The team will include doctors and nurses as well as social workers and other health care professionals.
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.
For all types of trials, you will work with a research team. Your participation will be most successful if you follow the protocol carefully and stay in contact with the research staff. Some terms that will help you understand what happens in a trial are defined below. A placebo is an inactive pill, liquid, or powder that has no treatment value. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. A blinded or masked study is one in which participants do not know whether they are in the experimental or control group in a research study.
Those in the experimental group get the medications or treatments being tested, while those in the control group get a standard treatment or no treatment. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U. Food and Drug Administration-regulated drug, biological, and device products. Registration Deadline: The FDA Amendments Act of requires that all trials, regardless of sponsor, must be registered in full no later than 21 days after the first patient was enrolled.
The PI is ultimately responsible for determining that registration requirements are met. Unregistered trials will not be considered for publication in journals that adhere to ICMJE standards. Questions about policies of a specific journal should be addressed to that journal directly. For federally funded grants, penalties may include the withholding or recovery of grant funds.
UConn A-Z. According to NIH : A clinical trial is a research study 1 in which one or more human subjects 2 are prospectively assigned 3 to one or more interventions 4 which may include placebo or other control to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Who is responsible for registering a trial? Moreover, throughout the duration of the trial, after consent is signed, you can withdraw from the study at any point, without any fear of consequences.
All clinical trials have to follow a protocol a list of instructions for all study sites performing that trial. Within the protocol, there is a list of inclusion and exclusion criteria that study staff must follow. If you meet all of the inclusion criteria and do not match any of the exclusion criteria, then with your consent, you will be eligible to participate in the study.
This is determined through a prescreening phone call and a screening visit with the study team. You will notified if you do not meet the criteria to be able to participate in the study. You will be meeting with the study doctor, and their staff. The staff includes the Study Coordinators and Study Nurses, who are well versed in the study procedures and will be able to answer any questions you may have throughout the trial.
The Study Coordinators will be your main contact throughout the duration of the trial, they will be able to help you for any study related matters. If you find a clinical trial that you may qualify for. Your first step should be to reach out to the contact person for the study. With your consent they will ask you some qualifying questions over the phone to see if you meet the basic criteria for enrollment.
If you do, you will be brought to the site for what is known as a screening visit. During this visit you and the study team will review the informed consent forms. If consent is given, some assessments will be performed.
The study team will walk you through any assessments or questions you may have. Do not hesitate to ask questions! A placebo is an inactive substance such like a pill or a liquid it will match the form of the IMP.
A placebo offers no medical value. It is important to use placebos in research because it helps to compare the data from the placebo group to the experimental group to be able to fully assess the effectiveness of the treatment.
Blinded means that the participant will not know what experimental group they have been assigned too. Double-Blinded means that the participant and the study team are both unaware of what treatment the subject receives.
There are some trials that are called Open-Label studies, in these studies, the subject and the study team are aware of the treatment that the participant has been assigned to. Your study team will inform you which type your study falls into. Your study team will be documenting any changes to your health through the study if there are any.
Any known adverse reactions or side effects will be told to you during the informed consent process. Some of the benefits of participating in a clinical trial is that you may receive a treatment for your condition that may not be widely available to others at the current moment and your health will be closely monitored by a study team.
A potential risk may be that you receive no treatment for your condition and are assigned to the placebo group. The data collected will still help the overall collective research process and may be able to help others with the same condition.
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