Clinical Trials

There is no cost to participants in a clinical study. All medical care, medications and equipment related to the research investigations are provided at no charge. Most participants are paid to help assist with the costs of traveling to and from office visits.

Your identity and other personal information, including that which pertains to your health, medical care and study participation, are protected according to the regulations set forth by both the United States and Texas state governments. *These rules do permit the sharing of some of your information with the research sponsor and certain government officials under very specific circumstances. This allows the sponsoring organization to consult with us about the progress and result of the study and also contributes to the protection of both your health and privacy during your participation. Research organizations are also subject to inspections by the FDA and the research sponsor, and to questioning by Institutional Review Boards and Data Monitoring Committees. Confidentiality regulations apply in these situations. There are also other legal and ethical guidelines that must be followed by medical professionals as well as their office staff.

In addition, we are required by law to provide you with detailed information about the study so that you may give your “informed consent” to become a study volunteer. These details will discuss study purpose, procedures, duration, possible risks and benefits, protection of your health and privacy, optional health treatments that you may wish to consider, treatment of any health problems that could be encountered as a result of study participation and other important information.

*For more information about medical privacy regulations, please visit this link.

Your study-related care is provided by a team led by Dr. Lucas, Dr. Goldsby, registered nurses, research coordinators and other medical professionals.

A Phase One Study:
Phase I studies focus on assessing the drug’s safety. This initial phase of testing in humans is done in a small number of healthy volunteers, who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body–how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing.

A Phase Two Study:
Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second “control” group will receive a standard treatment or placebo. Often these studies are “blinded”–neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies.

A Phase Three Study:
In a phase III study, a drug is tested in several hundred to thousands patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug’s effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years. Seventy to ninety percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug.

Post-Marketing — Late Phase Three/Phase Four Studies:
In late phase III/phase IV studies, pharmaceutical companies have several objectives than can include comparing a drug with other drugs already in the market and/or looking at a drug’s long-term effectiveness and impact on a patient’s quality of life. Many studies are also designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.

Clinical research refers to studies in which people participate as patients or volunteers. Different terms are used to describe clinical research, including clinical studies, clinical trials, studies, research, trials, and protocols. Clinical research may have a number of goals, such as developing new treatments or medications, identifying causes of illness, studying trends, or evaluating ways in which genetics may be related to an illness.

Strict rules for clinical studies have been put in place by NIH and the U.S. Food and Drug Administration (FDA). Some studies involve promising new treatments that may directly benefit participants. Others do not directly benefit participants, but may help scientists learn better ways to help people