Frequently Asked Questions
How do I get evaluated for participation in a clinical trial?
The first step in determining if you potentially qualify for a clinical trial is to complete a short phone screen with a member of our staff. This can be done by calling us directly at (843) 608-1950 or by asking your healthcare provider to send a referral. An initial assessment would then be scheduled, if appropriate. Participation in an assessment and/or research study comes at no cost to you. More information about what's involved in the assessment process can be found on the Alzheimer's Research and Depression Research pages.
If you are an individual with no current cognitive impairment or complaints, and interested in Alzheimer’s prevention trials participation, in most cases just a phone screen is sufficient to evaluate for possible study eligibility.
What happens once I am enrolled into a clinical trial?
Once enrolled into a clinical trial, each participant is monitored closely throughout the entire duration of the research study. The frequency and length of scheduled visits will vary depending on the specific study. Our center will also coordinate care with the participant’s primary care physician and can provide information collected during the research visits that is relevant to clinical care, such as lab work, cognitive testing scores and MRI reports.
The Phases of Clinical Trials
The U.S. Food and Drug Administration (FDA) maintains a highly regulated drug approval process. After the lab development, the drug is tested on various animal species for safety and efficacy. If the animal testing is shown safe and beneficial, the drug may proceed to Phase I of research.
• Phase I: Is the treatment safe?
The study is conducted on a small sampling of human volunteers (20-80) to determine any side effects and how the drug is processed in the body.
• Phase II: Does the treatment work?
The study is expanded to a larger group of people (100-300), to further evaluate the drug’s safety and effectiveness.
• Phase III: Is it better than what’s already available?
The study is further expanded to a larger group of people (1,000-3,000) to confirm the treatment’s effectiveness, monitor side effects, compare it with standard treatments, and collect information that will allow the experimental drug or treatment to be used safely. After Phase III, the drug still only has an approximately 60% chance of becoming FDA approved, pending all the research gathered up until that point.
• Phase IV: What else do we need to know?
In this phase, the FDA keeps a close watch on the drug even after it becomes commercially available, to observe the full effects of the drug treatment over a long period of time.
What are the risks associated with participation in clinical trials?
Although there are many potential benefits that result from participation in clinical trials, it is important to understand that clinical trials also involve risks. These risks may vary depending on the specific study and will be discussed in detail during the informed consent process for the study. In more general terms, the risks for participation may include:
• A larger time and attention commitment than standard treatment, including visits to the study site, additional tests, more treatments, hospital stays or complex dosage requirements.
• Unpleasant, serious or even life-threatening side effects to experimental treatment
All studies are required to be approved by the Institutional Review Board (IRB) to protect the subjects participating in research for safety and well being. The purpose of the IRB is to safeguard the rights and welfare of human subjects involved in clinical research at our site.
What is informed consent?
The informed consent process involves talking to a doctor and/or study coordinator about the trial and reviewing the consent form document with him or her. This allows the participant to learn all of the key information about a clinical trial before deciding whether or not to participate. This includes the purpose and goal of the study, all study activities that will take place, the length of the study and visit schedule, as well as any potential benefits or risks that you may encounter while participating in the study.
Additionally, you are strongly encouraged to ask any questions that you may have about the study during this time. Once the informed consent discussion is complete, you will then be asked to sign the consent form if you decide to continue with study participation.
Is a study partner required in order to be considered for participation in a clinical trial? What will his/her time commitment look like?
For Alzheimer’s trials, the answer is yes. Every individual participating in Alzheimer’s clinical research must have a reliable study partner/informant. The study partner is an integral part of the clinical trials process and is usually a family member or close friend who is able to answer questions about the study participant’s health, well being, recent events, etc. The time commitment required from the study partner varies depending on the study, so it is important to ask questions about the potential visit schedule and length of visits.
For Depression trials, there are a different set of processes and assessments that do not require the need for a study partner.
What do single-blind and double-blind studies refer to?
In single or double-blind studies, participants do not know if they are receiving the study drug or a placebo, so study participants and evaluators are able to describe results without bias. "Blind" studies are designed to prevent members of the research team or study participants from influencing the results, allowing for more scientifically accurate conclusions. In single-blind studies, the patient is unaware of what treatment is being administered, but the research team knows. In a double-blind study, only the pharmacist is knowledgeable of the drug being administered; members of the research team are not told which medication or placebo the patient is receiving, which ensures that their study observations are not biased. In the event of a medical emergency, it is possible when necessary to find out what the patient is taking.
Will I be compensated for participating in a clinical trial?
Depending on the study, you may be eligible to receive compensation for your time and travel expenses incurred while participating in a clinical trial. Not every study offers compensation for participants, but a member of our staff can provide you with more details about a specific study's compensation eligibility when you're being evaluated for potential enrollment.
Can a research volunteer leave a clinical trial after they have begun participation?
Yes. As a research participant, you have the right to withdraw from a study at any time, even after the informed consent forms have been completed and signed.
What happens when a clinical trial is over?
Once a clinical trial has ended, researchers must analyze the results to determine their significance. After a phase I or II trial, they must decide whether to advance to the next phase or discontinue testing altogether.
For a phase III trial, once the study has been completed, researchers are tasked with assessing the medical importance of the data and publishing the results in a scientific journal. If the results show that the new treatment or drug is both safe and effective, it may receive FDA approval for widespread use and become standard practice.