Clinical Trial
What is a Clinical Trial
A Clinical Trial is a research study conducted to evaluate the safety and effectiveness of a new Investigational Product (medications or devices) not yet available to the public, or an Investigational Product (medications or devices) available to the public. A Clinical Trial must adhere to the strict regulatory guidelines established by the Food and Drug Administration (FDA) and other regulatory agencies. Participation in a clinical trial is voluntary. Your physician may suggest benefits from participating in a clinical trial; however, the decision to participate is yours alone to make.
Most Clinical trials are conducted in phases. There are four main phases of clinical trials: Phase I, Phase II, Phase III and Phase IV.
Phase I clinical trials help to establish not only the safest dose of an Investigational Product but overall safety of the Investigational Product being tested, which is of utmost importance. These clinical trials are generally conducted in a small number of healthy volunteers, both men and women, with no critical medical conditions, including the condition the drug or device is being tested for. In many cases, a Phase I clinical trial is the first time the Investigational Product (medications or devices) is being used in humans.
Phase II clinical trials help to establish that the appropriate dose determined in Phase I are safe as well as effective. These clinical trials are generally conducted in a larger number of volunteers of both men and women who have the specific medical condition the Investigational Product is being developed to treat.
Phase III clinical trials help to confirm the doses of the Investigational Product are safe and effective for the medical treatment the Investigational Product is being tested for. The number of volunteers for Phase III trials can range from 100 to 5,000 and may be conducted worldwide.
Phase IV clinical trials are generally performed after the Investigational Product has been approved by the FDA and may provide additional information regarding the Investigational Product to ensure the safety and effectiveness of the Investigational Product.
Why do people volunteer to participate and what can you expect if you volunteer?
People volunteer to participate in a clinical trial for various reasons:
- To receive the latest, most advanced Investigational Product long before the investigational product is available to the general public.
- To have a medical option to their current medical treatment which may not be effective. It is important to remember that a clinical trial is used specifically for the development of an Investigational Product, not necessarily to treat your disease.
Volunteers can expect:
- A full medical evaluation and diagnosis made by a qualified physician.
- Close medical monitoring, including study related laboratory tests, x-rays, and other medical procedures specific to the clinical trial you volunteer to participate in.
- Regular medical examinations to evaluate your progress.
- Regular communication with the study staff.
Your participation as a volunteer in a clinical trial begins after you have signed the informed consent, which has been approved by an Institutional Review Board (IRB), whose primary purpose is the protection of human volunteers, such as yourself.
An informed consent is a document that must be approved by an IRB before it can be presented to a potential volunteer. When all your questions and concerns have been addressed by the physician in charge of the clinical trial, and you have had time to review the informed consent document, you will sign the informed consent and your participation in the clinical trial may begin. A copy of the signed informed consent will be provided to you for your records. Remember, no clinical trial medical procedures, including being asked to stop taking any prescription medications you are taking can be done until after you have signed the informed consent. Participation in a clinical trial is voluntary—you have the right to withdraw your consent at any time during your participation in the clinical trial without any negative effects related to your medical care.
How does volunteering for a Clinical Trial affect the care received from your physician?
Your participation in a clinical trial will not affect the care you are receiving from your primary care physician. You are encouraged to talk to your doctor about your participation in a clinical trial. The physician in charge of the clinical trial does not replace your primary care physician but works with your physician to provide you with additional health care options. Your records during your participation in a clinical trial may be shared with your physician, or they may remain confidential at your request.
Participation in a clinical trial is a commitment between you and the physician in charge of the clinical trial. It is important for your own safety and well-being that you follow the instructions given by the research staff. Keep all appointments required for the clinical trial and take the Investigational Product as instructed.
It may be helpful to know your participation in a clinical trial may help in the development of a new Investigational Product, which could benefit many people suffering from the same medical condition.
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Register to participate in a Clinical Trial
Therapeutic Areas
All clinical trials are conducted by experienced investigators that excel in their respective fields. Our Clinical Research Coordinators, Research Nurses and highly trained support staff ensure the accuracy and integrity of each clinical trial.
- Allergy/Immunology
- Cardiology
- Dermatology
- Endocrinology/Nutrition
- Gastroenterology
- Gynecology
- Internal Medicine
- Nephrology
- Neurology
- Podiatry
- Psychiatry
- Rheumatology
- Sleep Disorders
- Urology
- Vaccines
- COVID-19
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