Participating in a clinical trial is the best way you can contribute to the advancement of medicine.
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If you have ever taken prescription or over-the-counter (OTC) medicines, your life has been touched by clinical research and its amazing clinical trial participants. Through the important clinical research process, medicines, medical devices, and vaccines are developed for those who need them most.
Choosing to participate in a clinical research study is a big decision and can be a positive and rewarding experience. Clinical trials are highly regulated with strict safety and ethical guidelines and we take those regulations very seriously. Your safety is our number one priority. We're here to answer your questions.
We are a dedicated, compassionate team of healthcare professionals whose primary mission is to help improve the lives of our patients. We accomplish this by providing a knowledgeable, friendly staff and a comfortable environment for all patient appointments.
By participating in one of our clinical trials you become an active partner with our skilled medical staff in learning more about your diagnosed illness and assist in the development of future treatments.
Health insurance is not required and there is no cost to participate in one of our trials. All laboratory, diagnostic procedures and physician visits are paid for by the sponsoring pharmaceutical company. In addition you may receive compensation for your time and travel to our office.
WHY PARTICIPATE IN A STUDY?
As part of a study, you will receive medical care for your condition from experts in that field.
All study related evaluations, treatment and follow-up will be provided to you at NO COST and you may receive payment for time and travel.
By participating in a research study, you will help provide information to researchers about investigational treatments that may help your condition.
You may also benefit society by contributing to a better understanding of your condition, which could lead to treatment advancements,
What is a clinical trial?
A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called "inclusion criteria" and the factors that disallow volunteers from participating are called "exclusion criteria." These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants' safety, and ensure that researchers learn the information they need.
How does a clinical trial work?
In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.
A placebo is an inactive product used to assess the experimental treatment’s effectiveness.
The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.
What can volunteers expect if they choose to participate?
In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers' health will continue to be monitored during and after the trial. A detailed description of what's expected of volunteers will be outlined in consent forms along with specific clinical trial information.
What is informed consent?
An informed consent is a process in which the participant learns the key facts about the trial before deciding to participate or not. To help with this decision, the doctor and/or nurse explain the details of the trial. These details include the purpose, duration, requirements and key contacts. The risks and benefits are also explained. Then the participant decides whether or not to sign the document. The informed consent is not a contract.
What are the benefits and risks of joining a trial?
Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However, there are risks involved.
Possible benefits for volunteers:
Play an active role in their health care.
Gain access to research treatments before they are widely available.
Obtain medical care at health care facilities during the trial.
Help others by contributing to medical research.
Possible risks for volunteers:
There may be unpleasant, serious, or even life threatening side effects to experimental treatment.
The experimental treatment may not be effective.
The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.
Please note: volunteers may withdraw from a study at any time for any reason.
Does information remain confidential and private?
Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information. This is explained more specifically in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.
What happens after the trial?
After a study phase is complete, the data is collected to determine the drug's effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer-review. Data then may be submitted to the Food and Drug Administration (FDA) for approval.
If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost— to other drugs already on the market or assess a drug's long-term effectiveness and its impact on the quality of a person's life.