Clinical Trials

Frequently Asked Questions

 
  1. How do I get evaluated for participation in a clinical trial?
    For consideration for Alzheimer’s or Depression trials, the first step is to complete a phone pre-screen questionnaire with a member of our team. If interested in Alzheimer’s trials, you will be given information about trial opportunities and/or scheduled for a memory assessment to obtain baseline measures that will allow us to determine which trials, if any, are most appropriate for you. If you are interested in Depression trials and potentially meet the criteria for the current trial offerings, you would be scheduled for a Standard Depression Assessment to further evaluate for trial participation. For all other therapeutic areas, trial eligibility is determined by a different set of processes. If you think you may be appropriate for any other therapeutic trials that we currently offer, please discuss with your primary care provider and reach out to the point of contact on the trial listing in our clinical trials database.
  2. 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. Scheduled visits 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 are relevant to clinical care, such as lab work and MRIs.
    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.
  3. 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 to protect the subjects participating in research.
    Institutional Review Board
    Roper St. Francis (RSF), in accordance with the Code of Federal Regulations, has established an Institutional Review Board, also referred to as the “IRB.” The authority under which the IRB is established and empowered includes authority granted by the Governing Body of RSF and the Governing Body of each RSF Hospital subsidiary: Roper Hospital, Roper Hospital- Berkeley, Bon Secours St. Francis Hospital and Roper St. Francis Mount Pleasant Hospital. The purpose of the IRB shall be to safeguard the rights and welfare of human subjects involved in clinical research conducted at RSF or its subsidiaries. The IRB will review and approve the protocol, consent form and any other documents pertaining to each specific study. It will ensure both in advance and by periodic review that appropriate steps are taken to protect human subjects participating in the research.
  4. What clinical trials are currently enrolling?
    The therapeutic areas include Alzheimer’s Disease, Bone Marrow, Cardiac, Depression, Oncology, Orthopedic, and Wound Care. Click here to search for trials that are currently enrolling study participants.
  5. What is informed consent?
    The informed consent process involves talking to a doctor 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.
  6. Is a study partner required in order to be considered for participation in a clinical trial? What will his/her time commitment be?
    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 and other therapeutic areas, there are a different set of processes and assessments that do not require the need for a study partner.
  7. 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.
  8. 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.
  9. Can a participant leave a trial once it has started?
    As a research participant, you have the right to withdraw from a study at any time, or simply decide not to participate at all after the informed consent process is completed.
  10. 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.

 

 


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