The Roper St. Francis Clinical Biotechnology Research Institute (CBRI) conducts ongoing research in a number of therapeutic areas, including Alzheimer’s disease, oncology, cardiology, mental health and wound care. Our team is comprised of clinical research physicians, research administrators, nurses, study coordinators, patient recruitment coordinators and research compliance coordinators.
The CBRI is the recipient of millions of dollars annually in research funding from both federal grants and private sponsor companies. This enables us to offer access to promising clinical trials on the frontier of treatment development, as well as innovative technologies and techniques, long before they become widely available to the general public.
Understanding Clinical Trials
Clinical trials are the foundation of all medical advances, and aim to evaluate new methods in the prevention, detection and treatment of disease. Potential interventional treatments being evaluated include new drugs, surgical procedures or devices or simply new ways to use existing treatments. The goal is to determine if a new treatment or therapy is effective and safe. Some trials also look further into finding ways to improve the quality of life for people with chronic illnesses.
Clinical trials offer a source of hope for many people, as well as the opportunity for researchers to find the most effective treatments for others in the future.
Importance of Clinical Trials
Research is a collaboration of scientists, doctors and volunteer participants who work together to develop new ideas and approaches in medicine and science, and to answer questions about humans that could not be answered without the use of clinical trials. Research can be observational in nature or related to a new drug or treatment option for anything from the common cold to chronic diseases to diseases without a cure. Specifically, in the drug approval process, research is vitally important to ensure the drug or medical treatment is safe and effective before it is made available to the general public.
For a drug to go from initial development in the lab to being available at the pharmacy it takes an average of 12 years of research and rigorous testing. And the majority of drugs will not make it that far. In fact, only about 0.01% of drugs in initial development become approved for commercial use. A large number of drugs and treatments that are now widely available were first shown to be effective through the use of clinical research.
Benefits of Volunteering
As a clinical trials volunteer, you will have access to promising drugs, medical devices, or treatment approaches before the general public. You will also have the benefit of receiving free health care for the duration of the trial, as well as support and training in how to manage disease related behaviors, both for the participant and their caregivers. Many people volunteer primarily out of altruism, based on their desire to help advance medical science and benefit patients down the road.
The Clinical Trials Process
What to Expect in a Research Study
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.
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, 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.
FAQs about Clinical Trials
How do I get involved in a clinical trial?
to search by therapeutic area for trials that are currently enrolling study participants.
What are the risks associated with participation in clinical trials?
Although there are plenty of 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:
- Unpleasant, serious or even life-threatening side effects to experimental treatment
- A larger time and attention commitment than standard treatment, including visits to the study site, more blood tests, more treatments, hospital stays or complex dosage requirements.
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. The participant is informed of all of the key information about a clinical trial before deciding whether or not to participate, including:
- purpose and goal of the study
- all study activities that will take place
- the length of the study and visit schedule
- 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 be?
Yes. Every individual participating in 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.
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 is being administered, but the research team knows. In a double-blind study, only the pharmacist is knowledgeable of the nature of the drug being administered; members of the research team are not told which patients are getting which medication, which ensures that their study observations are not biased. In the event of a medical emergency, however, it is possible and 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.
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.
What happens when a clinical trial is over?
After a clinical trial has ended, researchers analyze the results to determine their significance. After a phase I or II trial, they need to decide whether to advance to the next phase or discontinue testing.
After a phase III study has been completed, researchers assess the medical importance of the data and publish the results in a scientific journal. If the results show that the new treatment or drug is both safe and effective, it may become standard practice.