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 new or improved treatments.

Why are clinical research trials important?

Everyone would like to receive effective treatment with drugs and procedures that work, that are safe, and that cost as little as possible. The advances in medicine and science are the direct result of new ideas and approaches developed through research. Until a drug or treatment is used with a large number of individuals, 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 diseases or conditions.

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 participate in drug trial, an individual must first be diagnosed with the condition for which the trial is being conducted. This 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.

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How are drugs tested?

Guided by U.S.A. 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 with 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 drug 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 enters the third phase of testing – advanced clinical trials. In phase III studies, a large number of patients with the targeted condition are given the investigational treatment to evaluate its effectiveness, dosage and side effects. After all these phases 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 is determined to be safe and effective, it is given FDA marketing approval. Before a clinical research study can be initiated at a hospital or an institution, the protocol which describes the procedures 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 proposed research studies to assess potential benefits and risks and to insure that the study is safe, that participants are protected and fully informed.

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 a traditional treatment or are given a placebo (an inactive medication which appears identical to the investigational treatment). To avoid biased results, studies are often conducted as “double-blind.” Where neither the patients nor the physicians know who is receiving the investigational treatment.