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FAQ's

How can I participate in a clinical drug trial?
As much as we would like to give everyone the opportunity to participate in a study, a person's medical history may prohibit this from happening. Our first and foremost intention is for the well being of the patient. To participle in drug trial, an individual must first be diagnosed with the condition for which the trial is being conducted. The is can be done in one of two ways. They can either have their personal physician submit their records to the clinic for review, or have the clinic perform a physical examination and diagnosis. The content of the physical examination is totally dependent on the clinical drug trial.
Once it has been determined that a person can be a participant in a clinical trial, he or she will then be asked to sign an informed consent form. This informs the participant about the guidelines and procedures they will need to follow during the study. Also, it informs the participant of the possible side effects that may occur from taking the study medication. After signing the informed consent form the individual is then placed in a study.

How are drugs tested?
Guided by U.Sl laws and regulations, a drug must go through a number of different testing phases to prove that it is both effective for the targeted medical condition and is safe for use in patients. The first step in a drug's development process is laboratory investigation where extensive chemical and animal studies are conducted to gain an understanding of how the drugs works. Next, the medication is evaluated for safety in small group of healthy human volunteers. If test results prove satisfactory, the drug is tested on a small number of patients with the targeted condition, to determine actual benefit. If these rigorous screening steps are passed successfully, a new medication enterers the third phase of human testing -- advanced clinical trials. In phase III studies, a significant number of patients with the targeted condition are given the investigational treatment to evaluate its effectiveness, dosage and side effects on a large scale basis. After all these phase of research are successfully completed, a new drug is prepared and submitted for review by the US Food and Drug Administration (FDA). If the drug treatment is determined to be safe and effective, it is given FDA marketing approval. Before a clinical research study can be initiated at t hospital or institution, the way or protocol, by which it will be conducted must first by reviewed by the FDA and an Institutional Review Board(IRB). And IRB is a group of both medical and non medical representatives of the community who review human medical research studies to assess potential benefits and risks and to insure that participants are fully informed.

Why should I participate in a clinical research trial?
By participating in a research study you will help provide information to researchers about investigational treatments that may help your condition. YOu may also benefit society by contributing to a better understanding of your condition, which could lead to a new or improved treatments.

Why are clinical research trials important?
Everyone would like to receive effective treatment in routine medical practice; drugs and procedures that work, are safe, and cost as little as possible,. There advances in medicine and science are the direct result of new ideas and approaches developed through research. Until a drug or treatment is used on a large scale basis, it is difficult to asses how effective it really is or what side effects may occur from its use. Through clinical studies, researchers are able to learn which approaches work best. This knowledge translates into better medical management of diseased or condition.

What kinds of clinical research trials are there?
Clinical research trials generally fall into two groups:
comparative studies and open label studies. In comparative or "controlled" trials one group of participants receives the investigational treatment, while a similar "control" group receives either traditional treatment or given a placebo (an inactive medication which appears identical to the investigational treatment). To avoid biased results, studies are often conducted as "double-blind." This means that neither the patients nor the physicians knows who is receiving the investigational treatment.
In an open trial, no attempt is made to disguise the investigational treatment; no placebo, or control treatment is used. As a result, both physician and patient knows which treatment is being provided.