Advances in Research & Clinical Trials | Lewis Cancer & Research Pavilion

Cancer clinical trials at the Nancy N. and J.C. Lewis Cancer & Research pavilion

What are cancer clinical trials?

Cancer clinical trials are research studies conducted to discover new ways to prevent, diagnose, and treat cancer while improving patients' quality of life. These trials involve testing drugs, medical devices, screening methods, behavioral changes, and other medical interventions. By participating in a clinical trial, patients contribute to advancements in cancer care while receiving cutting-edge treatment.

At the Lewis Cancer & Research Pavilion (LCRP), we are committed to offering these trials in collaboration with national, state, and regional partners, including the National Cancer Institute's Community Oncology Research Program (NCORP), Eastern Cooperative Oncology Group (ECOG) and the American College of Radiology Imaging Network (ECOG-ACRIN), Southwest Oncology Group (SWOG), NRG Oncology, the Gynecologic Oncology Group, Wake Forest, the University of Rochester and Georgia CORE (Center for Oncology Research & Education). These partnerships allow us to provide our patients with access to the latest treatments in a safe, community-centered environment.

How clinical trials work

Clinical trials are carefully designed research studies that follow strict protocols to ensure safety, reliability, and effectiveness. Each trial is conducted in phases, starting with small groups to test safety and gradually expanding to larger groups to confirm results. These studies involve healthcare professionals, such as doctors, nurses and research coordinators, who work closely with participants throughout the process. Participants receive detailed instructions, regular health evaluations and support during and after the trial. This collaborative approach ensures that every aspect of the trial meets the highest scientific and ethical standards.

Clinical trials at LCRP: A comprehensive program

The LCRP is involved in approximately 45 clinical trials at any given time, covering a wide variety of cancer diagnoses, treatments and screening methods. Our robust program includes participation in phase II and III clinical trials and a focus on improving access to clinical trials throughout Southeast Georgia and the Lowcountry of South Carolina.

Our program extends beyond treatment trials, encompassing prevention, screening, diagnostic, quality-of-life and cancer care delivery research studies. Each trial is rigorously monitored for safety and follows a specific protocol to ensure the well-being of every participant.

Benefits of clinical trials

Participating in a clinical trial offers many benefits, the main benefit being access to promising treatments that may not yet be available to the general public. Clinical trials often provide treatments that are as effective as, or more tolerable than, standard approaches. Additional benefits include:

Receiving personalized care from a dedicated nurse/research coordinator.
Contributing to advancements that may benefit future patients.
Accessing the same high-quality care provided across all LCRP services.

The ultimate goal of clinical trials is to enhance patients' health and longevity while addressing critical research questions about cancer prevention and treatment.

Types of clinical trials

Prevention trials

Prevention trials explore strategies to lower the risk of developing cancer. These studies may involve testing new medications, dietary supplements or lifestyle changes aimed at reducing cancer occurrence. For example, some trials at LCRP focus on preventing side effects like chemotherapy-induced nausea or reducing the recurrence of certain cancers. These trials are critical for identifying ways to prevent cancer or harmful treatment side effects before they develops.

Screening trials

Screening trials evaluate methods to detect cancer at earlier, more treatable stages. These trials focus on symptomless individuals and aim to improve the accuracy of diagnostic tools. By identifying cancer earlier, patients have improved survival rates.

Diagnostic trials

Diagnostic trials test innovative methods to identify cancer more precisely. These trials often involve patients showing signs or symptoms of cancer and comparing new diagnostic tools against older ones. Improved accuracy in diagnoses can lead to earlier interventions and better-tailored treatment plans.

Treatment trials

Treatment trials are at the core of clinical cancer research. They evaluate new drugs, therapies or combinations of treatments for their effectiveness and safety. At LCRP, many treatment trials are conducted to address a wide range of cancers, providing patients with access to cutting-edge therapies that may become the standard of care in the future.

Quality-of-life trials

Quality-of-life trials aim to enhance the well-being of cancer patients and survivors by addressing side effects and emotional challenges. These trials explore solutions for managing symptoms such as nausea, depression, sleep disorders or treatment-related fatigue. At LCRP, a current quality-of-life trial focuses on improving outcomes for head and neck cancer patients.

Cancer Care Delivery Research

Cancer Care Delivery Research (CCDR) is a multidisciplinary science that seeks to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery. Through LCRP’s partnership with the NCI Community Oncology Research Program, we are able to offer care delivery trials at several of our locations. One current Cancer Care Delivery Research study seeks to improve medication adherence in patients with breast cancer who have been prescribed a CDK 4/6 inhibitor.

Participation criteria for clinical trials

Each clinical trial has specific "inclusion criteria" that define who is eligible to participate and "exclusion criteria" that determine who cannot join. These guidelines are based on factors such as age, sex, type and stage of cancer, previous treatments and overall health. These criteria are essential for making sure that the trial produces accurate and meaningful results while protecting the participants' safety. They also help researchers focus on specific populations most likely to benefit from or contribute to the study.

Participation is entirely voluntary, and eligibility criteria are not used to reject individuals personally. Instead, they are a necessary step in ensuring the scientific validity of the trial and boosting the safety of the study for all participants.

Patient safety and security during trials

Patient safety is the highest priority in all clinical trials. Before a trial begins, it undergoes rigorous review and approval by the St. Joseph's/Candler Institutional Review Board (IRB). The IRB is responsible for ensuring that every aspect of the trial is ethical, scientifically sound and designed to minimize risks to participants. Ongoing monitoring throughout the trial confirms that safety protocols are consistently followed.

Participants are protected through an informed consent process, where they receive detailed explanations about the trial’s purpose, procedures, risks and benefits. This process allows participants to make fully informed decisions about their involvement. Additionally, the LCRP team is trained in best practices for clinical research and works closely with participants to address any concerns or side effects immediately.

Advancing clinical research through partnerships

The LCRP’s clinical trials program thrives through collaborations with leading national, regional and state research organizations. By partnering with programs like NCORP, LCRP has expanded its reach and access to innovative cancer trials. These partnerships enable the LCRP to participate in phase II and III trials, offering access to therapies that are not yet widely available and prioritize representativeness by focusing on enrolling patients throughout Southeast Georgia and the South Carolina Lowcountry.

Additionally, collaborations with institutions such as Georgia CORE, Wake Forest and the University of Rochester strengthen the program’s setup. These partnerships enhance the quality and diversity of available trials so that patients in the local community can access the same advancements as those in major city areas. This network of partnerships allows the LCRP to maintain its role as a leader in cancer research, bringing hope and progress to patients and families.

What are clinical trials and why are they important?

Clinical trials are research studies that test how well new medical approaches work on people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. People who take part in cancer clinical trials have an opportunity to contribute to knowledge of and progress against cancer. Clinical trials are essential for advancing medical science; they help researchers identify safer, more effective treatments and upgrade existing approaches to cancer care.

What are some of the benefits of taking part in a clinical trial?

Clinical trials offer patients a chance to actively contribute to the advancement of cancer treatment and research. They may also provide access to innovative therapies years before they are widely available. Additionally, clinical trial participants are closely monitored by a team of experienced healthcare professionals, which can enhance the quality of care they receive. The benefits of participating in a clinical trial include:

Participants have access to promising new approaches that are often not available outside the clinical trial setting.
The approach being studied may be more effective than the standard approach.
Participants may be the first to benefit from the new method under study.
Results from the study may help others in the future

For many patients, the opportunity to help others in the future through their participation is a deeply rewarding experience.

What are some of the possible risks associated with taking part in a clinical trial?

While clinical trials aim to improve cancer treatment, there is always an element of uncertainty involved. Participants may experience unexpected or more severe side effects than anticipated. Additionally, because trials are experimental, there is no guarantee that the treatment will be effective for every participant.

New drugs or procedures under study are not always better than the standard care to which they are being compared.
New treatments may have side effects or risks that doctors do not expect or that are worse than those resulting from standard care.
Participants in randomized trials will not be able to choose the approach they receive.
Health insurance and managed care providers may not cover all patient care costs in a study.

All potential risks are carefully explained during the informed consent process to ensure participants can make educated decisions about their involvement.

Who can participate in a clinical trial

All clinical trials have guidelines about who can participate. The factors that allow someone to participate are called "inclusion criteria," and those that disallow someone from participating are called "exclusion criteria." These criteria are based on factors such as age, sex, the type and stage of a disease, previous treatment history and other medical conditions. Inclusion and exclusion criteria are designed to ensure that the study produces reliable results while keeping participants safe. These criteria are not personal judgments but are essential for achieving the scientific goals of the study.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors, nurses, social workers and other healthcare professionals. They check the participant's health at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial and stay in touch after the trial is completed.

During the trial, participants may undergo regular check-ups, lab tests and imaging scans to monitor their health and the treatment's progress. They are also provided with detailed instructions to ensure they follow the study protocol accurately. Throughout the trial, the research team remains available to address any concerns or questions.

Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should inform the research team about the withdrawal and the reasons for leaving the study. Participants are never obligated to continue in a trial if they feel it is no longer the right choice for them. Leaving a trial does not affect the quality of care they receive for their condition. However, providing feedback about their reasons for withdrawal can help researchers improve future trials. It is important to remember that participation is completely voluntary, and patients always have the freedom to choose what is best for their health.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by various organizations or individuals, such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, as well as federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), the Department of Veterans Affairs (VA), and the National Cancer Institute.

Sponsors are responsible for funding the research and ensuring that trials meet strict scientific and ethical standards. Their support allows for the development of cutting-edge therapies and diagnostic tools. Trials can take place in diverse settings, including hospitals, universities and community clinics, providing access to patients from all walks of life. The collaboration between sponsors and research institutions is vital to the success of clinical trials.

What about my safety?

Government guidelines ensure that clinical trials are carried out with the safety of the subjects as a top priority. Your rights and safety are protected through informed consent, careful review and approval of the clinical trial protocol and ongoing monitoring. The safety of participants is safeguarded by continuous oversight from Institutional Review Boards (IRBs) and ethical review committees. These groups ensure that trials are conducted responsibly and that any risks are minimized.

Contact Us

For more information about the Nancy N. and J.C. Lewis Cancer & Research Pavilion and our advanced clinical trials program, please call 912-819-5704. Together, we can improve cancer care, drive innovative research and support patients in our community and beyond.

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