Frequently Asked Questions
A: Clinical trials (also known as clinical research) are research studies in human volunteers that investigate treatments and observe patient performance with new treatments. They play an important role in developing new treatment options for a variety of diseases. Before any new treatment can be tested in humans, it must have shown positive results in the laboratory and/or in animal studies. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. The United States Food and Drug Administration (FDA) monitors most clinical trials to protect the participants and the general public. Ultimately, the FDA reviews and analyzes data from successful clinical trials to determine whether the experimental treatment should be approved for the treatment of a specific disease or disorder. Clinical trials may be carried out using completely new treatment options or using treatments that are already available. Clinical trials are the safest and quickest way to confirm whether new treatments are truly beneficial for patients.
A: At Harmonex Neuroscience Research, patients are given the opportunity to try new treatments for their conditions. Some of the treatments are already FDA approved and are already being used by doctors. However, pharmaceutical companies may find that the medication is more effective in a different population than intended. When this happens the companies will request that clinical trials are conducted. A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
A: Yes, new treatment options are safe for most subjects enrolled. However, if you were to participate in a study, one or more of the study's investigators will review the potential and anticipated risks and how they may affect you. Our number one goal is to help the subject find new treatments that will improve his or her quality of life. All Harmonex subjects are monitored closely to ensure that there is little risk to their health. In fact, our subjects receive special, individualized care that most medical and psychiatric clinics cannot offer. Ultimately you and your treating doctor(s) will need to determine if the potential benefits outweigh the risks of participating in a study, such as decreasing the symptoms or reversing the course of an illness that otherwise would not be available through standard treatments.
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
- Play an active role in his or her health care.
- Obtain comprehensive, free health screenings.
There are risks to clinical trials:
- The treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
- There may be unpleasant, serious or rarely even life-threatening side effects to treatment.
A: If you are interested in enrolling in the new treatment options available at Harmonex Neuroscience Research, please contact a member of our staff by email at firstname.lastname@example.org or telephone at 334.836.2000.
A: Clinical trials offer a look at future treatments. They determine whether a new and potentially better treatment is safe and effective in humans. Clinical trials may provide opportunities for you to receive a promising drug or treatment. Typically, currently approved therapies are compared with new therapies and your doctor may feel this is an appropriate treatment for you.
Things you should know before participating in a clinical trial
- Talk to your doctor
- You should always discuss the benefits and risks of participating in clinical trials with your doctor.
- Each clinical trial will have its own set of eligibility requirements. Your doctor will be able to help assess your eligibility for a specific trial.
- Informed Consent
- The FDA requires that an individual read and sign an informed consent form before being enrolled in a clinical trial. Informed consent is a process that ensures patients are given complete information about a clinical trial prior to their participation. The key facts of the study are included in a written informed consent form for participants to read and discuss with their families and doctors. Be sure you understand all the facts before you sign the consent form. Don't be afraid to ask questions!