A clinical research trial is led by an experienced medical staff that tests a study drug or medical device in volunteers who are participating in a study. These tests are used to see if the study drug or device is safe and effective for people to use. Each clinical trial follows a protocol, which sets guidelines that the study must comply with. It gives details about the number of patients allowed in the trial, the schedule of tests and procedures, and the duration of the study. All clinical research trials adhere to strict rules and guidelines, which are set by the Food and Drug Administration.
To aid volunteers in making informed decisions about participating in a clinical research study each participant is provided with an informed consent document. FDA requires that all individuals are advised on what the requirements of a clinical research trial are. As a volunteer you will find the following information in the informed consent:
- The purpose of the Clinical research trial
- Expected duration of the study and number of expected volunteers to participate
- An explanation of all study related procedures and assessments
- Schedule of events that will take place during the course of the study
- Subjects responsibilities and restrictions during participation of the research trial
- Explanation of benefits, risks, or possible discomforts that may be experienced during the research trial.
- Information on the experimental treatment
- Details of compensation for participation
- Other treatments that a volunteer may want to consider before becoming involved in the research study
- Confidentiality of all volunteers
- Each subjects right to withdraw from the study at anytime
- Possible Benefits that a volunteer may receive from the being in a clinical trial
Clinical research trials are conducted to find out if new study drugs are safe and effective against disease. Investigational products are evaluated to see how they compare to approved treatments or to promote treatments that are not readily available on the market. Some clinical trials require that the subject, study staff, and doctor do not know whether the volunteer is receiving the study drug or placebo (an inactive substance). This means that some people will not be receiving treatment throughout the course of the clinical trial.
Clinical research trials may have some adverse reactions that might cause discomfort or unpleasant side effects. Because the treatments being studied are new the medical staff and doctors do not always know what the side effects will be. Most side effects can be temporary and can be resolved when treatment has stopped. It is also possible that some side effects may show after the course of treatment. All risks depend on the type of treatment involved with the study and all known risks or discomforts should be explained to you by the researchers.
All clinical research trials follow guidelines that provide inclusion and exclusion criteria to see if volunteers are eligible to participate in the study. Factors are based on age, medical history, current treatments, and current medical conditions. This criteria is used to identify appropriate subjects and to maintain their safety during the course of the trial.
- Alzheimer’s Disease
- Memory Loss
- Multiple Sclerosis
- Stroke With Spasticity
- Parkinson’s Disease
In clinical research trials, a placebo is considered an inactive substance. In other words, there will be no treatment or benefit associated with the placebo. In research, experimental treatments are usually compared to a placebo to determine the effectiveness of treatment.
Most clinical research studies will compensate participants for their extended time and travel. This information will be outlined in the Informed Consent Document that will be provided to you at your first visit. Payments are submitted upon each completed study visit.
Yes. Each volunteer has the option to withdraw from the clinical trial in which they are participating in at anytime. If you choose to discontinue the trial you will need to inform the research team of your decision. A follow up visit will need to be scheduled before discontinuing the study.
Most studies do not incur fees for participating subjects. This will be outlined in the Informed Consent Document provided to you at your first visit.
Bradenton Research Center is a dedicated research center affiliated with Bradenton Neurology, as well as other physicians in the area. Our Principal Investigator, W. Alvin McElveen, MD, has over 18 years experience in clinical trials. Since 1992 we have conducted more than 90 clinical research studies and have earned the confidence and trust of our patients by giving them the very best medical care. Our Research team consists of 25 years of a combined research and medical experience. Due to our dedication to the advancement of medication, you are guaranteed a quality experience.
You will have access to consultations with experienced medical professionals, learn of new an innovative treatments, and help others by contributing to medical research.