Participating in Clinical Research
It is important for physicians to stay abreast of the latest advances in medical treatment. Women’s Health Texas offers our patients the option of trial participation conveniently at their ObGyns office and not only by traveling to a new center or hospital. We feel strongly that research is our best hope for advancing treatment options. We are therefore committed to performing high quality, comprehensive clinical research.
Our care center Women Partners in Health is currently enrolling patients for studies in:
- Recurrent Vaginal Yeast
To learn more and see if you’re eligible to participate, please contact us today. To offer more information about what it means to participate in a clinical study, here are answers to common questions.
What is a clinical study?
Taking part in a clinical study is a bit different from having regular care from your doctor in that you may have more tests and medical exams than you would otherwise. A clinical study is a research project done with human volunteers to learn more about new treatments. Some volunteers are interested in access to new treatment options. Others volunteer to help advance science. Whatever your reason for participating, the study group will closely monitor your health and protect your privacy.
What to expect during a study?
Before you start you will be taken through all of the steps of the study by a physician. This is called the Informed Consent process. You will have the opportunity to have all of your questions answered before you decide whether to participate in this study. During a clinical study, doctors, nurses, and other health care providers may be part of your treatment team. They will monitor your health very closely. You may have more tests and medical exams than you would if you were not taking part in a clinical study. Your treatment team also may ask you to do other tasks. For example, you may have to keep a log about your health or provide other health information to your physician.
Is there any cost associated with a clinical study?
There are absolutely no financial costs to you to participate in this clinical study. The treatment and care are provided to you free of charge.
Will I be reimbursed for my expenses?
Yes. The clinical trial administrators typically reimburse you for your expenses. There will be no charge to you or your insurance company for any medications and procedures that are required by this study. Details on compensation will be shared with you by the study investigators.
What if I changed my mind?
That’s no problem. All research studies are voluntary, so if you have a change of heart after you’ve applied or even during the clinical study you can opt-out at any time for any reason or no reason at all.
What is a clinical study?
A clinical study (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational studies address health issues in large groups of people or populations in natural settings.
Where do the ideas for studies come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.
Who sponsors clinical studies?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as:
- Medical institutions
- Voluntary groups
- Pharmaceutical companies
- Federal agencies such as the National Institutes of Health (NIH)
Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
What is a protocol?
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 may participate in the trial
- The schedule of tests
- Medications and dosages
- 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.
What is 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.
What is a control in a control group?
A control is a 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.
Why participate in a clinical study?
Participants in clinical studies can:
- Play a more active role in their health care
- Gain access to new research treatments before they are widely available
- Help others by contributing to medical research
Who can participate in a clinical study?
All clinical studies have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical study are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”.
These criteria are based on such factors as:
- Type and stage of a disease
- Previous treatment history
- Other medical conditions
Before joining a clinical study, you must qualify for the study
Some research studies seek participants with illnesses or conditions to be studied in the clinical study, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
If you are interested in learning about clinical study available at Women’s Health Texas, please contact your provider about the studies they are participating in through the patient portal, or during your appointment. You aren’t required to be an established patient with the practice to be eligible for consideration.