What Is A Clinical Trial?
Clinical trials are research studies designed to answer specific questions about investigational medications. The trials are designed to assess both the safety and effectiveness of a product and are carefully conducted under rigorous U.S. Food and Drug Administration (FDA) guidelines. They are the only way that medications, medical devices, and vaccines can become available to us. Every medication, whether prescription or over-the-counter, has been through the clinical trial process.
Clinical trials can also be conducted on medications that are already approved by the FDA to determine if it may be useful for another condition, or to determine the safety or effectiveness of long-term use.
Benefits Of Clinical Trials
If you are thinking about volunteering for a clinical trial, you should know that doing so can provide some benefits. One great benefit that can result from your participation in a clinical trial is your ability to attain professional care from a team of educated, experienced medical experts throughout the time you spend in the trial. Because medical teams oversee clinical trials, they are oftentimes able to offer quality information and advice regarding the medical conditions that trial participants have. Study-related care and procedures, as well as treatments and supplies provided to participants during a clinical trial are often at no cost. Individuals who opt to participate in clinical trials are frequently able to access the treatments used in the trial before they are released to the general public. If the drug used in the clinical trial is actually effective, this means that you could gain access to a form of treatment that improves your health. Another advantage you can gain by participating in a clinical trial is the ability to generate supplemental income for yourself. Many clinical trials may pay participants for their time and travel expenses.
What To Expect During The Clinical Trial
In order to know what to expect if you decide to participate in a clinical trial, you should gain a basic understanding of the kind of research that is being conducted. If you have been selected to test the efficacy of the drug, the clinical trial will incorporate you actually taking the drug and being examined to determine whether the medicine is effective. Generally, the site staff of a clinical trial will include study doctors, study coordinators or nurses and/or other types of health care professionals. Their role will be to analyze your health and determine if the trial is a good fit for you. After doing so, they will provide you with guidance and instruction regarding what you need to do throughout the trial, called Informed Consent.
When you qualify for the trial, the study team will monitor you to see how you are tolerating the medication and assess changes to your condition over time. The study team follows you closely during the clinical trial to ensure your safety and that study rules and regulations are consistently followed. Depending on the condition that you have and its severity, you may find yourself subject to more doctor visits and diagnostic tests than you'd receive during normal healthcare visits. These visits and tests are designed as part of the clinical trial to ensure that the reseearch site can monitor your safety and health.
Clinical Trial Size
Depending on the type of product being tested, as well as its developmental stage, researchers will first enroll patients into a small pilot study. After this, larger studies may be conducted on patients so that comparisons can be made between the new product and others which have already gained approval. Once positive safety data is collected, the number of patients in studies will generally increase. The size of a clinical trial can vary, and can take place in one or multiple countries.
Clinical trials are valuable to world health because they help scientists and members of the medical community understand whether a medication, device or vaccine is safe and effective. If you are interested in gaining more information regarding clinical trials, you can read the National Heart, Lung, and Blood Institute's important articles "What Are Clinical Trials?" and "What Are The Possible Benefits and Risks of Clinical Trials?" You may also contact us at any time and we will help provide you with information to decide if participating in a clinical trial is right for you.
To learn more, you can contact us, find a study center near you, or find a clinical trial.
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