We, at Urological Surgical Associates are pleased to be able to afford our patients access to selected clinical trials in our community setting.

Our physicians, recognized on a national level for their expertise and knowledge, are invited to participate in clinical trials by the top pharmaceutical and research companies in our country.

Below is general information about what a clinical trial is.

What is a clinical trial? / Risks and Benefits / Phases of a clinical trial / What is a protocol? / What is a placebo? / What is informed consent?

What is a clinical trial?

A clinical trial, also known as a research study, is used to answer specific questions about or to study new ways of using a therapy. The purpose of a clinical trial is to determine the safety and efficacy of a therapy in treating a particular disease or condition in humans. This includes looking at the benefits as well as the potential risks of the therapy.

What are the possible risks and benefits or participating in a clinical trial?

The possible risks of participating in a clinical trial include:

•    You may experience side effects to the therapy or procedure

•    You may receive a therapy that may be less effective than current therapy

•    You may receive a therapy or undergo a procedure which may be beneficial to others, but ineffective for you

•    You may receive a placebo (does not apply to all clinical trials)

The possible benefits of participating in a clinical trial include:

•    You may obtain expert medical care by leading physicians in the field of cancer research

•    You may gain access to new drugs or treatments not available to other patients

•    You will have your health closely monitored, and you will be evaluated for any side effects you may experience from therapy

•    You may be one of the first to benefit from a medication if the treatment is found to be effective

•    You may gain personal satisfaction in knowing that you are contributing to the advancement of cancer research

What are the different phases of a clinical trial and what do they mean?

Clinical trials are conducted in humans only after laboratory and animal studies have outlined the potential safety and efficacy of the therapy.

Therapies are tested in a series of clinical trials that progress in "phases." There are four phases of clinical trials. Phases one through three are conducted before a drug is approved by the Food and Drug Administration (FDA). The fourth phase occurs after the therapy has received FDA approval.

Phase I Trials

Phase I trials are the first to be conducted in humans. They are conducted in a small group of healthy volunteers who do not have the disease or condition that the therapy is ultimately intended for. Occasionally these studies are conducted in patients. The main goal of Phase I trials is to determine if the therapy is safe. So, researchers look to see whether participants experience any side effects associated with the therapy. Phase I trials are also used to establish an appropriate dose for the later phases of clinical studies. Finally, phase I trials are used to determine how the therapy acts in the body and how the body reacts to the therapy.

Phase I cancer trials for cancer therapies are an exception. Phase I trials for cancer therapies are often conducted in patients who have cancer instead of healthy volunteers. However, they still collect information about how the therapy acts in the body and how the body reacts to the therapy, as well as safety and appropriate dosages.

Phase II Trials

Phase II trials continue to test the safety of the therapy, but they also look at the efficacy, or how well the drug works for the disease or condition it's intended for. Phase II trials usually include a small number of patients that have the disease or condition that the therapy is ultimately intended for. In cancer Phase II may consist of larger pivotal well-controlled studies that usually represent the most rigorous demonstration of a drug's efficacy. Phase II trials for cancer usually focus on a specific type of cancer (like prostate cancer).

Phase III Trials

Phase III trials often enroll a large number of patients that have the disease or condition the therapy is intended for. Phase III trials help to gain a better understanding of the therapy's efficacy, side effects, and potential risks and benefits. These studies are comparative, either to the existing therapies or placebo.

Phase IV Trials

Phase IV trials are sometimes called post marketing trials because they are usually conducted after a therapy has been approved by the FDA and is available or "on the market." Phase IV trials are often conducted to provide additional details required to learn about the drug's efficacy and/or safety profile. Different formulations, dosages, duration of treatment, drug interactions, and other drug comparisons may be evaluated. They usually look at the long-term safety of the therapy when used in the general patient population.

What is a protocol?

Clinical trials have objectives and guidelines that are outlined in a protocol. A protocol is the plan of the clinical trial. It usually includes information on who can participate in the trial, what types of tests or procedures will be performed during the trial and when they will be performed, the medicines that will be used, and the length of time of the study. One of the purposes of a protocol is to ensure that consistent treatment is provided for all participants so that the information gathered can be compared and analyzed.
Participants in clinical trials are seen on a regular basis by the research staff to monitor their health and to determine the safety and effectiveness of the treatment.

What is a placebo?

A placebo is a substance or formulation (e.g., tablet, capsule, pill, liquid or powder) that has no treatment value. It is an inactive substance. In some clinical trials, experimental therapies are compared with placebo to determine if the experimental therapy is more effective than giving no therapy (the placebo).
In cancer clinical trials, placebos are only given when there is no existing standard therapy approved by the FDA. This occurs in Phase III cancer clinical trials.

What is informed consent?

Informed consent is the process of learning about clinical trials and deciding whether or not you want to participate. This is a process that's used worldwide. You will be required to sign an informed consent. The research staff will discuss why the trial is being done, what the researchers want to find out from the trial, what tests or procedures will be done during the trial, how long you will have to participate, what benefits and risks can be expected from the trial, other treatment options available, and most importantly, the fact that you have the right to stop participation in the trial at any given time. If you decide to participate in the trial, you will be given an informed consent agreement, which details all of the facts about the study. You will have the option of taking the documents home to discuss with family members/friends and your doctor. After reviewing the documents, you will be asked to sign the agreement and will be given a copy for your safekeeping. Remember, you are free to ask the research staff any questions before, during, and after the trial.