Cancer – Solids (Oncology)
- MORD trial: The purpose of this trial is to gain new information that will contribute to the development of new tests help that will diagnose cancer and determine the prognosis for cancer patients. Click here for more information.
- C. Difficile trial: The purpose of this trial is to evaluate the effectiveness of two medications in the treatment of Clostridium difficile infection. Click here for more information.
What is a clinical study?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies. Clinical trials provide the basis for the development of new drugs, biological products and medical devices. In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. Clinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are already available to each other. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.
How do I know if a clinical study is right for me?
Participating in clinical trials is completely voluntary and it's important to discuss with your physician what options you may have and the pros and cons of each. Many patients greatly benefit from the treatment options offered through clinical trials. The results of clinical trials can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative or diagnostic products and interventions.
Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These will be described in the informed consent document for a particular trial. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider. It is important that a participant’s usual health care provider work with the research team to ensure that the study protocol will not conflict with other medications or treatments being received.
How are participants protected?
Researchers provide potential and enrolled participants of a clinical trial with information about a clinical study – a process called informed consent. This information helps people decide whether they want to enroll, or continue to participate, in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions and activities to measure participant understanding. In general, a person must sign an informed consent document before entering a study to show that he or she was given information on risks, potential benefits, and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.
Each federally supported or conducted clinical study and each study of a drug, biological product or medical device regulated by FDA must be reviewed, approved and monitored by an institutional review board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is ethical and the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other things. The IRB also reviews the informed consent document.
In addition to being monitored by an IRB, some clinical studies are also monitored by a data safety and monitoring board, which is a group of independent scientists who monitor the safety and scientific integrity of a clinical trial. Various Federal agencies, including the Office of Human Subjects Research Protection (OHRP) and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
What should I ask my doctor or research team?
First, you will want to find trials that are being offered in your community and that are for the type of condition or illness that you have. Many trials also have additional prerequisites, such as age, gender, treatment history or life expectancy.
Why is this study being done?
What are my other treatment options? What are the pros and cons of each?
What are the results of this study in earlier phases? Are they likely to apply to me?
Will this study affect my daily life?
How long does this study last? What if I still need treatment when it ends?
Can I talk to other participants in the study?
How do I find a clinical study?
For information about clinical studies at Baton Rouge General, contact the Clinical Trials Office at (504) 799-4400.
Another resource is ClinicalTrials.gov, which is a national database of clinical trials in the U.S. as well as international studies. There, you can search by condition or location to find in-depth information on current trials that are available in your area.
Baton Rouge General’s Clinical Trials Office (CTO) supports clinical research at the hospital by providing tools and services for the compliance, education, and operation of clinical studies. Baton Rouge General’s Clinical Trials Office works with industry sponsors and clinical investigators to offer patients opportunities to participate in studies of investigational medicines, devices, procedures and therapies. The CTO works across disciplines to help researchers conduct innovative trials that will advance medicine for future generations.
Clinical investigators involved in human research are responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and all applicable regulations. Investigators are also responsible for protecting the rights, safety and welfare of subjects under the investigator's care and for the control of drugs under investigation.
The Clinical Trials Office staff are trained and experienced in conducting clinical trials and assist investigators in meeting these obligations. The CTO provides investigators a support team to assist in streamlining the regulatory, contractual and financial aspects of conducting research, as well as providing operational support for the conduct of industry sponsored clinical trials at the facility.
How to become a Principal Investigator
A Principal Investigator (PI) is the physician who leads the conduct of a clinical trial at each investigative site. 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 including trial identification, contract negotiation, and financial and regulatory processing.
Physicians interested clinical research opportunities at Baton Rouge General should contact the Clinical Trials Office manager Kristi Rau at email@example.com or (504) 799-4400 ext. 4424