VOLUNTEER FOR CLINICAL RESEARCH IN SAN ANTONIO, TX
ARE YOU INTERESTED IN PARTICIPATING IN A CLINICAL STUDY? VOLUNTEER TODAY!
Learn more about what it means to volunteer for a clinical research study. Volunteering can be a great opportunity for people to receive medical services at no cost and to learn more about their medical condition. Volunteers in medical research studies, in most cases, are compensated for their time and travel commitments in the form of a stipend. At Texas Dermatology, we ensure participation is a positive experience for every volunteer.
BECOME A CLINICAL RESEARCH VOLUNTEER!
FREQUENTLY ASKED QUESTIONS
A clinical trial is a research study to evaluate the safety and effectiveness of an experimental medical device, treatment, or medication. After showing benefit in the laboratory, new treatments must be tested among small groups of people to determine the proper dose and to test safety. After a dose has been determined, the dose is tested on large groups of volunteers to evaluate the safety and effectiveness of the treatment for a specific condition, such as eczema, psoriasis, or acne.
The Food and Drug Administration (FDA) requires pharmaceutical companies to conduct clinical trials before new treatments can be made available to the public for prescription or over-the-counter use. Clinical trials are carefully monitored under the FDA’s strict regulations. Clinical trials are important to ensure that people receive safe and effective treatments. The trials provide a way to develop new treatments that are as effective, more effective, or safer than treatments already on the market. The trials also make it possible to develop new treatments for conditions that currently have no treatments available.
Once a patient contacts a research site, the caller will usually have a brief telephone interview to determine if he or she would likely be a good candidate for the study. A screening visit may then be scheduled for the candidate to discuss the trial in more detail and to further screen the candidate for qualification, possibly resulting in study enrollment.
The participant must give a full and accurate medical history regarding past and current medical conditions, illnesses, and all medications used currently and in the recent past. The participant must follow all directions regarding the use of the study medication, and return all medication upon the completion of the study. They must attend all scheduled appointments to ensure that the study doctor monitors the progress of the participant.
There is no cost to participate in a clinical trial. All study medication and study related office visits, procedures, and laboratory tests are provided at no cost to the participant. Financial compensation is available for those who qualify at the completion of the trial.
In many clinical trials, one group of patients will be given an experimental drug or treatment, while patients known as the control group are 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. Comparing the two groups allows researchers to evaluate the effectiveness of the study drug or therapy. In “blind” or “masked” studies, patients and sometimes the study staff do not know if they are receiving the experimental treatment or a placebo.
There are numerous potential benefits to participating in a clinical trial: Aggressive treatment For patients with advanced disease, clinical trials offer some of the most aggressive options for treatment. Early access to treatments When an agent being tested in a clinical trial proves superior, patients benefit by having received a treatment they wouldn’t have been able to receive otherwise. Close monitoring Because clinical trial treatments are experimental, each trial has a protocol, or action plan, that specifies how and when patients are seen, given their medication and monitored with blood and other diagnostic tests. Patients involved with trials will interact closely with a physician or scientist and a research nurse. Advancing medicine Although the main motivation for participating in a clinical trial is the possible benefits realized by the patient, participants are also advancing progress in the discovery of causes and potential treatments and cures for the illness.
There are four phases of clinical trials. Phase 1 is focused on safety of a medication and involves a small group of subjects. Phase 2 involves a larger group of subjects with continued focus on safety and efficacy. Phase 3 is a larger study looking at more subjects and capturing data on efficacy of the drug with continued focus on safety. Phase 4 trials occur after a drug has been FDA-approved to gather information on the drug’s effect in various groups of people with long-term use.
Clinical trials are rigorously regulated. As with any new medication or surgical procedure, treatments are first studied thoroughly in the laboratory. If basic research establishes that a new method or chemical seems likely to succeed safely and effectively in patients, it can be submitted for approval for a clinical trial. Not only must the submission meet regulatory guidelines established by organizations such as the Food and Drug Administration (FDA), but also it must first be reviewed for scientific merit by the Hospital Clinical Investigations Committees. Aside from reviewing the scientific basis for the trial, as well as its safety and efficacy (the ability of the treatment or drug to produce its intended effect), the IRB gives serious consideration to the proposed trial’s “informed consent” – the document that physicians give to patients explaining the trial and its potential risks. All clinical trials must have a protocol, or action plan, which describes in detail what will be done in the study, how it will be conducted and why the various portions are necessary. Once approved, clinical trials are monitored through the hospitals’ Clinical Investigations Support Offices, where research nurses follow patients closely and data managers track their progress.
The Institutional Review Board can stop a study if it appears to be causing unexpected harm to participants, or if there is evidence that the risks outweigh the benefits. An IRB can also stop a study if there is clear evidence that the new treatment is effective, in order to make it widely available. Patients participating in a clinical trial may leave the study at any time, since their inclusion is voluntary.
The informed consent that you will receive from the physician should explain the major elements of the trial and answer questions you might have about the motivations for the study, what is required of you in order to participate, potential risks and benefits, alternatives for treatment and potential costs. Questions you may wish to ask include:
- Why is the study being done?
- Has the drug or treatment in this study been tested before?
- Who is sponsoring the study?
- What will happen during the study?
- What am I required to do to participate in the study?
- Will I need to be hospitalized to participate? If not, how often will I need to come to the study center?
- What are the possible risks or discomforts?
- What are the possible benefits of taking part in the study?
- What other treatment alternatives do I have?
- Will I receive the study drug or treatment during the clinical trial, or is it possible that I may be part of a control group receiving a placebo instead?
- Are there any costs involved in participating in the study or receiving the care as part of the study?
- Will I receive any compensation for participating in the study?
- What happens if I am injured as a result of my participation?
- What do I do if I need emergency care during the study?
- What are my rights as a participant in the study?
- What will be done with the information gathered from the study?
- Will I be able to get information about the results of the study?
- Who can I call with questions or problems?
Once you have had your questions answered to your satisfaction, you can consult with your health care providers, family and friends to decide whether participating in a clinical trial might beneficial for you. Please keep in mind that all clinical trials have specific guidelines about who can participate. Guidelines are based on such factors as age, type of disease, medical history and current medical condition. So while volunteering for a clinical trial is appreciated, it is important to recognize that it is not always possible to include all volunteers in a trial.