Frequently Asked Questions

What is clinical research?

Clinical research is a type of study of clinical or biomedical questions that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue. Clinical research studies do not necessarily all involve medical treatments or experimental therapies. Clinical research is important in order to develop new therapies and diagnostic procedures as well as to understand how diseases begin and progress. Observational studies may help identify risk factors for the development of a particular disease, such as the association between smoking and lung cancer. Outcomes-based research can help doctors identify the most effective therapies and treatments for a number of conditions. Epidemiologic studies examine specific populations to clarify how often a disease occurs or is found in a given group (the incidence and prevalence), the individual factors that can cause or worsen disease progression, and the types of health and lifestyle decisions that people make. Another aspect of clinical research is the development of new technologies for use in health care, ranging from surgical tools and materials to hearing aids and artificial limbs. In cancer treatment, virtually all advances in the care of cancer patients has occurred as a result of clinical research. Clinical trials are one important type of clinical research.

What are clinical trials and why are thy important?

Clinical trials are research studies designed to find new and better ways to treat patients and to ensure individuals receive safe and effective treatments for their health conditions, from heart disease to headaches. They provide the means to develop new treatments that are as effective, more effective, or safer than treatments already on the market; they enable researchers to discover new therapeutic uses for currently available medications, and they make it possible to develop innovative treatments for conditions that currently have no treatment.

Clinical trials are unique studies in that they rely on the participation of patients to test the new therapies. They are conducted only after a long process of research on the new treatment has already been completed.   Before ever testing a new treatment with people, studies are performed in research labs and with animals to examine possible benefits and side effects. By the time the treatment is given to patients in a clinical trial, it has been under study for many months or years.

Clinical trials are conducted in three phases, each aimed at answering a different research question. Each newly developed treatment must go through all three trial phases.

Phase I trials: These first studies in people evaluate how a new drug should be given (for example, by mouth, injected into the blood, or injected into the muscle), how often, and in what dose. Phase I trials are the first tests of a new treatment in humans, so they usually include only a small number of patients, sometimes as few as a dozen.

Phase II trials: A Phase II trial continues to test the safety of the drug and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of disease. Like Phase I trials, they often include a limited number of patients.                                                                                                                                           

Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard for treatment. Participants are usually assigned at random either to the standard treatment group or to the new treatment group (this process is called randomization). Phase III trials often enroll large numbers of people and may be conducted around the world in various settings, including doctors’ offices, hospitals, research centers and teaching institutions. Since most trials require periodic visits to the study physician, volunteers should take the location of the facility into consideration when deciding whether to participate in a clinical trial.

By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research. Medical advances can only be made through clinical research and discovery — and that begins with you. Without you, we couldn’t conduct our research; and without research, medical advances simply aren’t possible. By taking part in a clinical trial, you could help countless people all over the world live longer, better lives.

Who runs clinical trials?

Most clinical trials are sponsored by pharmaceutical companies, federal health agencies, medical foundations, medical centers, and universities; however, physicians may sponsor some clinical trials, particularly when the trial evaluates a currently available treatment for a condition other than for what it was previously approved.

Most clinical trials are sponsored by pharmaceutical companies, federal health agencies, medical foundations, medical centers, and universities; however, physicians may sponsor some clinical trials, particularly when the trial evaluates a currently available treatment for a condition other than for what it was previously approved.

Where do clinical trials happen?

Clinical trials are performed around the world in various settings, including doctors’ offices, hospitals, research centers and teaching institutions. Since most trials require periodic visits to the study physician, volunteers should take the location of the facility into consideration when deciding whether to participate in a clinical trial.
 
Our facility is located within:

The Vaz Clinic, P.A.

TVC Clinical Research

1103 North Sarah DeWitt Drive

Gonzales, Texas 78629

830-672-2424

Why should I participate in a clinical trial?

People participate in clinical trials for various reasons, including health, financial and societal reasons. Volunteers who participate in clinical trials help to further advance medical science, which can help others in the future.
 
Clinical trials provide volunteers with free health and medical information. In addition, financial compensation for time and travel expenses may be provided to study participants.

What is informed consent?

Informed consent is the process by which a potential study participant agrees to participate in a trial after being provided with information about the study and treatment. It includes an explanation of what’s involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment.
 
Participation in a clinical trial is completely voluntary. All questions about the study should be answered to the participant’s satisfaction before an informed consent form (ICF) is signed. Participants have the right to refuse participation or to withdraw their consent at any time during the study without penalty.
 
The wishes and best interest of the participant are considered at all times. Throughout the trial, participants will be provided with any new information that may affect their decision to continue their involvement in the study. In addition, the study physician may withdraw a participant at any time, without consent, if it becomes evident that it’s not in their best interest to continue.

What are my responsibilities as a participant in a clinical trial?

In the interest of safety, the participant must fully inform the study physician about past and current medical conditions, illnesses, and medications, follow the prescribed treatment plan and attend scheduled visits. Study personnel will explain other study-specific responsibilities.

Do I have to pay to be in a clinical trial?

There’s no cost for joining a clinical trial. Study medication, as well as study-related tests and procedures are usually provided at no charge to study participants. In some cases, you may be compensated for your time and travel expenses related to study participation.

What is a placebo?

A placebo is an inactive substance, which may be given to some of the study participants in a clinical trial as a control, so that researches can verify that any results can be attributed to the drug being tested assist in comparing the effects of the active study treatment.

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