Clinical research and trials are at the heart of all medical advances and directly contribute to improved treatment outcomes and breakthroughs in disease treatment
and management. Urological research and trials focus on diseases and cancers of the urogenital system including the: kidneys, bladder, ureters, pelvic floor, genitals,
hormones, fertility and sexual functioning.
The goal of research and trials is to determine if a new test or treatment is safe and effective. It also offers an opportunity for patients who have exhausted
traditional treatment options or who have difficulty paying for treatments.
There are many reasons to participant in clinical trials and research. Many participants have tried and failed traditional treatments or decline due to high risk of
side effects that decrease quality of life. Others find participation as a good solution to receive highest quality expert care at no cost. Some patients participate
to help others and contribute in moving medicine forward for the future generation.
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and
pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of
Veteran’s Affairs (VA).
As a private clinic, Adult Pediatric Urology & Urogynecology, PC is extremely selective in choosing partners and studies to ensure patient care remains the highest
Although you will receive all medical care related to the trial for free and some participants may qualify for a travel stipend most of our studies do not offer
payment for participation.
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care
expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the
answers to these questions are found in the informed consent document.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process
throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial
explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration,
required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign
the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer
specific research questions. A protocol describes what types of people can participate in the trial; the schedule of tests, procedures, medications, and dosages; and
the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine
the safety and effectiveness of their treatment.
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:,
In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage
range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to
commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies, delineate additional information including the drug’s risks, benefits, and optimal use.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in
safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a
clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual
participants’ names will remain secret and will not be mentioned in these reports.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or
treatment, while the control group is given either a standard treatment for the illness or a placebo.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess
the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know so that we may
retrieve any remaining medication and do an exit visit if possible.
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