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Clinical trials are research studies designed to answer specific questions about a medication or therapy. The trials are designed to assess both the safety and effectiveness of the drug being tested. Studies are sponsored by the pharmaceutical company, regulated by the Food and Drug Administration (FDA), and administered locally by companies like Qualmedica.
If you have ever taken a prescription or over the counter medication you’ve experienced the impact of a clinical trial. Someone volunteered to participate in the trial process so that people needing medicines, devices, or vaccines would be able to get them.
Patient volunteers that suffer with disease often benefit from participating in the study. They receive routine medical care by a licensed and certified physician, close monitoring to evaluate their response to the medication, and in many studies, relief from their symptoms. Many people volunteer because it brings them closer to medical discoveries that truly improve quality of life for themselves and others.
You can make a difference!
Participate in a clinical trial and make a difference in your life and the lives of many others.
Frequently Asked Questions
What are the benefits to patient volunteers?
- Receive free health exams on a regular basis throughout the study to assess initial and continuing health status.
- Gain access, at no cost, to new or expanded treatments not available through other means.
- Take a more active role in treating a particular disease or disorder
- Help answer important questions that might bring new and improved therapies to millions of other people in need of treatments.
- Receive compensation for time and travel to participate in the study.
Will I get active drug?
Some studies include a placebo group which means some of the patient volunteers receive an inactive version of the therapy. Often times this phase of the study is followed by an “open label” phase where all subjects receive active drug. Patient volunteers that participate in the shorter placebo phase are usually invited to participate in the open label phase. The placebo phase is usually short; the open label phase can last much longer.
Can I withdraw from a study?
Patient volunteers can change their mind and leave a study at any time. If you choose to leave a study our coordinators will explain the protocol and schedule your last visit with the investigating physician.
Can I participate in more than one study?
We encourage our patient volunteers to participate in as many studies as they like and as often as they like – but only one study at a time. Being part of the research is what makes the medicine of tomorrow a reality.
How is safety addressed?
The FDA provides strict guidelines on how clinical trials are conducted. Each study is carefully constructed and reviewed by a board of experts prior to start of patient recruitment. Our physicians take great care in reviewing lab results, patient vitals, and reported responses to the administered drug. If adverse events are observed the investigating physician will change dosage or stop administration of the drug.
Will I have to stop taking my current medication?
Most studies require patients to stop current medication before starting the new therapy. Other times the study evaluates the new therapy in combination with current medicine.
What if I don’t qualify?
Each study is designed with a specific set of inclusion and exclusion criteria. These criteria help improve the chances that the study answers the specific question being asked by the sponsor and the FDA. If you don’t qualify for one study you might qualify for another. Don’t get discouraged and keep looking for studies that fit your situation.