A clinical trial is a research study that evaluates new approaches to the prevention, diagnosis and treatment of disease. They involve human participation. Without this participation, the study may conclude without definitive answers. Clinical trials are sometimes called "clinical studies," "research protocols" and "medical research."
A clinical trial is one of the stages of a long and careful research process. You can search Henry Ford's clinical trials or call for more information about Henry Ford's clinical trials, (313)916-1784.
What are the Purposes of Clinical Trials? Why are they Important?
The purpose of all clinical trials is the same: to determine whether a new approach is more effective than current ones in the prevention, early detection or treatment of disease. Today's standards of care were yesterday's clinical trial.
Advances in medicine and science result from new ideas developed through research. Clinical trials help scientists develop improved treatments and sometimes lead to cures. The participants, themselves, stand to benefit first from the study.
Where do Clinical Trials Take Place?
They are underway throughout the country: in major medical centers, community hospitals and clinics, physicians' offices and VA hospitals in numerous cities and towns around the United States.
Are Clinical Trials Safe?
Many safeguards are in place to make clinical trials as safe as possible and protect patients. Before a human being ever receives a new therapy, it is carefully studied in the laboratory. Laboratory research determines how best to use the new methods with people safely and effectively. Any clinical trial involving people must be approved by the Institutional Review Board (IRB). The IRB is made up of doctors from different specialties, ethicists, administrators, and members of the public. An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure the protection of the rights and welfare of patients who are enrolled in clinical trials. Therefore, the IRB is authorized to review, require changes to, approve, or disapprove studies.
Through a process called informed consent you will learn about a study's treatments and tests, and possible benefits and risks, before deciding whether or not to participate.
Who is Eligible to Participate in a Clinical Trial?
Each study has its own guidelines for who can participate. Generally, participants are alike in key ways - such as the type of disease, age, gender and other factors.
What are the Phases of Clinical Trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of three phases:
Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular disease.
Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, and clinics nationwide.
Phase IV trials: Phase IV trial are also known as Post Marketing Surveillance Trials. They involve the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.
Who pays for the patient care costs on clinical trials?
Health plans and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. Ask a doctor, nurse or social worker from the study to help you determine in advance what costs are covered. The research costs, such as study drug, certain tests and doctor appointments, may be covered by the study sponsor.
How do I find out if I qualify for a clinical trial?
There are over 1,300 research studies being conducted at Henry Ford. To see if you qualify for one, please search our CLINICAL TRIALS DATABASE. If you don't see what you are looking for, you can search for more at http://www.clinicaltrials.gov/
