Clinical Research
As part of our continuing commitment to the promotion of wellness and prevention of disease, we provide an entry point into multiple research studies for major drug companies. Participating in a research study can be a personally satisfying and rewarding experience. As a volunteer in a clinical trial, you are contributing to the search for new medical treatments and aiding in the development of new medications. Participation in a research study is completely voluntary. All volunteers receive detailed information regarding the risks and benefits of participation in each study. We welcome all questions and concerns you may have. It is very important to us that before you decide to participate in a study, you are comfortable and aware of all aspects involved with being a research volunteer. You maintain the option of discontinuing your participation at any time. Check our current studies to find out what studies are now open for enrollment.
What is a clinical research trial?
A clinical research trial or study involves the direct observation of or data collection from people to determine the safety or potential benefit of an intervention such as a medication, device, teaching, training, or behavioral modification. Clinical research trials are conducted with volunteers, supervised by a physician, and must take place before new research treatments can be made available to the public. Clinical trials are an important step in making investigational medicines available for future use. Clinical trials are typically divided into different phases. Each phase is designed to gather specific information about the study drug or treatment.
Why are clinical research trials important?
Clinical research trials must take place before new research treatments can be made available to the public. Many currently available medical treatments have been analyzed through clinical trials, which are carefully monitored under strict government regulations. Clinical research trials are important to ensure that individuals receive safe and effective treatments for their health conditions. 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 not treatment.
Phase I
A Phase I clinical research trial is the first step in testing a new medicine or treatment in humans. These studies are looked upon as the initial safety trials and are designed to determine what happens to the drug in the human body. A Phase I study attempts to establish the best way to give a new treatment and establish the best dosage. This initial stage of testing usually includes a small number of study volunteers and typically lasts several months.
Phase II
A Phase II clinical research trial is designed to evaluate the efficacy of a drug once it has been shown to be safe. These studies provide preliminary data on how effective the drug is when given to research subjects who have the disease or condition to be treated. Phase II testing also helps determine common short term side effects associated with the drug. Phase II studies are well-controlled trials that are closely monitored and usually involve a relatively small number of subjects.
Phase III
In a Phase III clinical research trial the drug is tested on several hundred to several thousand subjects for whom the medication is eventually intended and typically last several years. Phase III studies generate additional safety and efficacy data for the pharmaceutical company and FDA. The results of a successfully completed Phase III trial are then used by a pharmaceutical company to apply for marketing approval from the FDA.
Late Phase III/Phase IV
Late Phase III/Phase IV studies are performed after a medicine is marketed. These studies are undertaken to continue to further understand the medication, and may be used to evaluate formulations, dosages, durations of treatment, and medicine interactions. Late Phase III/Phase IV studies are sometimes designed to compare a drug with other drugs already on the market. Another objective of late Phase III/Phase IV trials is to monitor a drug’s long-term effectiveness and impact on a subject’s quality of life.
Should I participate in clinical research?
People participate in clinical research trials for a variety of reasons, including health, financial, and personal needs. As a volunteer in a clinical trial, you are contributing to the search for new medical treatments and aiding in the development of cures for illness and medical conditions. However, participants in clinical research need to understand that there are both benefits and risks to be considered.
Benefits:
You help others by contributing to the advancement of medical research knowledge.
You play an active role in your own health care.
You gain access to promising treatments before they are widely available.
You obtain high quality, expert care from physicians during the course of the study.
Financial compensation may be provided to study participants in some clinical trials.
Risks:
The new treatment may not be effective or help you more than the standard treatment for your illness or health problem.
There may be side effects and other health risks that are not known when the study starts.
Being in a clinical trial may require an extended commitment involving study site visits, tests/treatments, more complex medication schedules, and recording of information.
Past Studies
Osteoporosis
Hormone Replacement Therapy
Birth Control
Heart Disease in Women
Sexually Transmitted Diseases
Vaginitis
Libido
Hot Flash – Post Menopausal
Urinary Tract Infection
Uterine Fibroids
Over-active Bladder
Endometriosis
Female Sexual Dysfunction
Vaginal Atrophy
For more information, please contact our Clinical Research Coordinator at 480-732-7405.
