Clinical Trials

Many of the advanced medical treatment options available today are in part the result of clinical trials. Clinical trials offered at Baton Rouge General provide patients in our community access to leading-edge treatments close to home. Through our hospital’s dedication to clinical research and affiliations with Tulane University School of Medicine as well as national organizations, we are able to offer our community opportunities to participate in clinical trials for new, state-of-the-art treatments.

For a listing of current clinical trials and research studies being offered at Baton Rouge General, click on a health category below. For more information about clinical trials and research available at Baton Rouge General, contact the Clinical Trials Office at (225) 237-1673 or email Jane.Byrne@BRGeneral.org.

Cancer / Oncology
Critical Care
Diabetes
Heart & Vascular
Neurology
Pulmonology / Lung
Women's Health

Q: What are clinical trials and why do people participate?
Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of a clinical trial is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

Q: Who participates in clinical trials?
Many different types of people participate in clinical trials. Some are healthy, while others may have illnesses.

A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention. Research procedures with healthy volunteers are designed to develop new knowledge, not to provide direct benefit to study participants. Healthy volunteers have always played an important role in research.

Healthy volunteers are needed for several reasons. When developing a new technique, such as a blood test or imaging device, healthy volunteers (formerly called "normal volunteers") help define the limits of "normal." These volunteers serve as controls for patient groups and are often matched to patients on characteristics such as age, gender or family relationship. They receive the same test, procedure, or drug the patient group receives. Investigators learn about the disease process by comparing the patient group to the healthy volunteers.

Factors like how much of your time is needed, discomfort you may feel, or risk involved depends on the trial. While some require minimal amounts of time and effort, other studies may require a major commitment in time and effort on behalf of the volunteer, and may involve some discomfort. The research procedure may also carry some risk. The consent process for healthy volunteers includes a detailed discussion of the study's procedures and tests.

A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat or cure that disease or condition. Research procedures with a patient volunteer help develop new knowledge. These procedures may or may not benefit the study participants.

Patient volunteers may be involved in studies similar to those in which healthy volunteers participate. These studies involve drugs, devices or interventions designed to prevent, treat or cure disease. Although these studies may provide direct benefit to patient volunteers, the main aim is to prove, by scientific means, the effects and limitations of the experimental treatment. Consequently, some patients serve as controls by not taking the test drug, or by receiving test doses of the drug large enough only to show that it is present, but not at a level that can treat the condition. A study's benefits may be indirect for the volunteers but may help others.

All clinical trials have guidelines about who can participate, called Inclusion/Exclusion Criteria. Factors that allow someone to participate in a clinical trial are "inclusion criteria." Those that exclude or not allow participation are "exclusion criteria." These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers.

Some studies need both types. Inclusion and exclusion criteria are not used to reject people personally; rather, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information they need.

Q: What do I need to know if I am thinking about participating?
Risks and Benefits:
Clinical trials involve risks, just as routine medical care and the activities of daily living. When weighing the risks of research, you can consider two important factors:
  1. The degree of harm that could result from participating in the study
  2. The chance of any harm occurring

Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to sign before participating in research. Also, a member of the research team explains the major risks of participating in a study and will answer any questions you have about the study. Before deciding to participate, carefully consider possible risks and benefits.

Potential Benefits:
Well-designed and well-executed clinical trials provide the best approach for participants to:

  • Play an active role in their health care.
  • Gain access to new research treatments before they are widely available.
  • Receive regular and careful medical attention from a research team that includes doctors and other health professionals.
  • Help others by contributing to medical research.
Potential Risks:
Risks to participating in clinical trials include the following:
  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment
  • The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more treatments, hospital stays or complex dosage requirements


Q: How Am I Protected?
Ethical Guidelines:
The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patient volunteers. By placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses.

Informed Consent:
Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain details of the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures and who to contact for various purposes. The informed consent document also explains risks and potential benefits.

If the participant decides to enroll in the trial, the informed consent document will be signed. Informed consent is not a contract. Volunteers are free to withdraw from the study at any time.

IRB Review:
Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) in order to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Potential research participants should ask the sponsor or research coordinator whether the research they are considering participating in was reviewed by an IRB.

Click here for more information about clinical trials. 

For more information about clinical trials and research available at Baton Rouge General, contact the Clinical Trials Office at (225) 237-1673 or email Jane.Byrne@BRGeneral.org.

The goal of the Baton Rouge General Clinical Trials Office (CTO) is to assist both new and experienced investigators with industry sponsored and investigator-initiated clinical research.

Clinical investigators involved in human research are responsible for the oversight of the clinical research according to an IRB approved protocol, Good Clinical Practice (GCP), and all applicable regulations. Investigators are also responsible for protecting the rights, safety and welfare of participants enrolled in a trial and control of investigational product (drugs or devices). The staff in the CTO are trained and experienced in conducting clinical trials and assist investigators in meeting their obligations.

Services offered to investigators coordinating industry funded studies through the CTO include:

  • Pipeline services for identifying possible clinical trials
  • Site selection and feasibility assessment
  • Budget development and negotiation, facilitate contract negotiations and execution, financial billing compliance, financial tracking and management
  • Logistical considerations and planning, study start up and staff training
  • IRB preparation and submission, IRB amendments, adverse events, annual reviews
  • Regulatory document compilation and maintenance 
  • Design of source documents and case report forms
  • Patient recruitment, screening, consenting and follow up
  • Liaison with pharmacy for drug administration, dispensing and accountability
  • Phlebotomy and specimen processing and storage
  • Data management services (data collection, data entry, query resolution)
  • Study close out and archive

In addition to industry funded studies, the CTO can also assist physicians in developing a clinical research protocol with sound scientific design.

How to become a Principal Investigator:
Being involved in clinical trials enables physicians to learn and become exposed to new medical therapies. The PI is responsible for the clinical research activities at the investigative site however, the CTO staff is in place to support the PI with all aspects of study management.

Physicians interested clinical research opportunities at Baton Rouge General should contact the Clinical Trials Office at (225) 237-1674 or email Jane.Byrne@BRGeneral.org.