What is clinical research?
Clinical research is the way physicians, scientists and pharmaceutical companies identify new and improved therapies for illness and disease. A clinical trial is a research study that answers a specific question or set of questions about a new therapy or way of using existing therapies.
The Food and Drug Administration (FDA) requires that all new medications be thoroughly tested for safety and effectiveness before your doctor can prescribe them. New medications are carefully tested in the laboratory before clinical trials in humans are conducted. All treatments in widespread use today were first proven safe and effective in clinical trials.
Research studies also investigate normal physiology and the changes in physiology that lead to disease. These help us understand why people develop symptoms and disease, and rarely do these studies involve the use of pharmaceuticals.
By participating in clinical trials, volunteers help advance medical research and improve the quality of life of others.
What is participating in a clinical trial like?
Clinical trials are often very much like regular visits to your physician or medical clinic. Study volunteers are treated with care and professionalism, and are seen in a doctor's office setting under the confidential supervision of the participating physician.
What are the risks and benefits of participating in a clinical trial?
Volunteer safety is always the number one priority in clinical research studies. The Informed Consent form you will receive before deciding to participate in a study will describe the potential risks and benefits of a specific study. In general, the benefits and risks of study participation are as follows:
Benefits
· Taking an active role in your health care
· Accessing new medical treatments
· Obtaining expert medical care
· Study visits are free of charge, including physical examinations, study-related doctor visits, study medications and laboratory tests
· Learning more about your disease
· The extra time and attention provided by the research staff
· Contributing to society by helping with the evaluation of new medications for current and future generations
Risks
· Side effects or adverse reactions to study medication
· Non-effectiveness of treatment or possibility of receiving placebo (an inactive substance, like a sugar pill)
How are clinical trial participants protected?
An Institutional Review Board (IRB) must approve all clinical trials. An IRB consists of physicians, scientists, and lay people from the community who review the study to make sure that subjects' rights are protected and that there are no unnecessary risks.
Any subject who participates in a clinical trial must first read and sign an Informed Consent form that describes the study. Informed consent means that you understand the nature of the study, that your questions have been answered to your satisfaction, and that you voluntarily agree to participate. The Informed Consent form will answer such questions as:
· Why is the research being done?
· What do the researchers wish to accomplish?
· What procedures or evaluations will be performed during the study?
· How long will my participation in the study last?
· What potential risks are involved?
· What are the potential benefits?
· What other treatment options are available?
Participation in a clinical trial is completely voluntary. You have the right to discontinue your participation at any time.
How do I get the key facts before giving informed consent?
OFDR research staff will discuss the study with you in detail, provide you with a copy of the Informed Consent form, and answer any questions you might have. Before signing the Informed Consent form, you should:
· Read the document thoroughly and ask questions of the research staff
· Take the consent form home and discuss with your family or friends, if you desire
· Review your options thoroughly: ask more questions
Who can participate in a clinical trial?
Guidelines for eligibility for a clinical trial vary by study, and are based on factors like current medical condition or disease, medical history, and age. Some studies require volunteers with specific diseases or conditions, while others seek healthy volunteers.
Who sponsors clinical trials?
Government agencies, pharmaceutical companies, healthcare institutions, medical device manufacturers, or individual physician-investigators may decide to sponsor a clinical trial.
How do I get involved as a participant in OFDR's research?
Contact OFDR by phone or e-mail. Your symptoms and general health will be assessed over the phone. If you are interested, and fit the criteria for a study, you will be scheduled for a screening visit in our clinic.
How long does a typical clinic visit last?
Your first visit may take up to a few hours, with follow-up visits typically lasting about 30 minutes.
How long do clinical trials last?
The average treatment study lasts approximately 8-12 weeks, but we also have long-term studies that may last for several years.
Do I need to live in the Oklahoma City area in order to be a participant?
No, but participants should live within a reasonable driving distance since all visits must be conducted on site.
As a clinical trial participant, should I continue working with my primary health care provider? Absolutely. Many clinical trials provide short-term treatment, but not extended or complete primary health care. Your health care provider can also work with OFDR's research team, ensuring that your outside treatments and medications do not conflict with the clinical trial protocol restrictions. At your physician's request, he/she may receive documentation of your study visits.
What if I want to discontinue my participation?
As described above, you can leave a clinical trial at any time - just let the research team know your reasons for leaving the study. You may be asked to return to the site for a study termination visit and to return any unused study medication.
Will I be paid for my participation?
Some clinical trials do pay participants. Also, researchers may reimburse your expenses associated with participation, such as transportation costs, childcare, meals, and accommodations. You will be informed of any compensation arrangements before the trial begins.