Frequently Asked Questions
What is a clinical trial?
A clinical trial is the process of scientific studies by which pharmaceutical companies prove that their new product or treatment option is safe, effective in treating the condition it is designed for, and well tolerated by patients. Studies conducted as clinical trials are federally regulated and follow strict protocols. Investigators must clearly explain the details of the study to patients before they agree to participate. All information collected during the clinical trial is submitted to the Food and Drug Administration (FDA) who can then approve the product or treatment option for general use.
Why are clinical trials important?
Clinical trials are vital because without them, no new medical treatment options or products would be developed. It is through research and clinical trials that important medical discoveries are made. Every current medication, treatment, or device available has gone through a clinical trial sometime in the past.
Are clinical trials safe?
While there is always some low risk involved in taking a novel medication, many experts believe that clinical trials are actually safer than standard medical treatments. This is because patients are monitored much more closely in a clinical trial environment than they typically are otherwise. When participating in a clinical trial, patients meet with their physicians frequently. Conversely, in a traditional medical practice, patients may be prescribed new mediations and not be scheduled for a follow-up visit with their physician until several months later. During clinical trials, patients often receive both blood tests and a medical examination at every visit. In traditional practice, follow up visits are normally not very thorough.
Why should I participate in a clinical trial?
There are several benefits to being a trial participant. As a participant, you will be taking an active role in your own healthcare. You may receive access to treatments otherwise unavailable, and will be contributing to important medical discoveries in the process. All tests and treatment given to you while you are participating in the trial are free, and you may even receive monetary compensation for your trial participation.
Am I eligible to participate in a clinical trial?
It depends on the particular trial. Read the details of the trial to determine if you fit the demographics. If you are not eligible for this particular trial, keep checking. Chances are you’ll be a perfect fit for another trial soon.
What is a phase I clinical trial?
A phase I clinical trial is a scientific study conducted to determine whether or not a new medical product, treatment, or device is safe to be used on humans. Phase I trials are conducted once the product, treatment or device has been tested in a laboratory environment and/or on animals. This phase of testing involves a limited number of subjects. Phase I trials help researchers verify the proper dosage of the drug, as well as, whether to administer it orally or intravenously. DIAGNAMICS does not conduct phase I trials.
What is a phase II clinical trial?
After researchers determine that a treatment is reasonably safe in humans (through the data collected in the phase I trial), they begin phase II trials on the treatment. Phase II clinical trials determine whether or not the product, treatment, or device is effective in treating the condition for which it was designed. Since they involve a larger number of subjects, phase II trials also provide further evidence of the treatment’s safety.
What is a phase III clinical trial?
Phase III clinical trials compare the new medical product, treatment, or device to the treatment options already available. These studies help determine whether the new treatment is more effective, or has fewer side effects, than the established treatment. Phase III clinical trials begin once both the safety and effectiveness of the experimental treatment have been proven (in phase I and phase II trials). They involve hundreds or thousands of subjects and are often “double-blind,” meaning that neither the patient nor the investigator knows which treatment is being administered.
What is a phase IV clinical trial?
Phase IV clinical trials are studies conducted once the FDA has approved a medical product, treatment, or device for general use. These studies may test the treatment’s long-term safety and/or its alternative uses (such as treating a second, unrelated condition.) Phase IV trials are less common than the other phases of clinical trials.