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What is Clinical Research?

Clinical research is a way for doctors and scientists to answer questions about healthcare. Research can find better ways to prevent, diagnose or treat diseases and disorders. There are many kinds of clinical research. For example, some studies test new medicines or devices. Other studies use interviews to learn about health problems.

What is a Protocol?

A protocol is a written plan that describes the goal of a research study and how the study will be conducted. For example, it describes the type of people needed to take part in the study. The protocol also outlines any procedures the participants will undergo.

What is a Clinical Trial?

Drugs and medical devices must be proven safe and effective in people before the U.S. Food and Drug Administration (FDA) will approve them for general use. A clinical trial is a study that tests a drug or medical device to see if it is safe and effective for treating people. The government has strict rules for clinical trials. These rules help to ensure that study participants are safe.

What are clinical trial "phases"?

Clinical trials that test drugs go through four stages or "phases." A Phase I clinical trial is the first time an experimental drug is tested in humans. It is usually given to a small group of healthy participants. The purpose of a Phase I study is to gather information on the drug's safety.

A Phase II clinical trial is usually the second stage of testing a new drug in humans. This phase commonly involves 100 to 300 participants. The participants usually have the disease for which the experimental drug is being tested. The purpose of this phase is to gather additional information on safety and to see how effective the drug is.

A Phase III clinical trial commonly involves 1,000 to 3,000 participants that have the disease for which the experimental drug is being tested. This phase usually compares the experimental drug to the current approved treatment for the disease. Side effects and effectiveness are also monitored during a Phase III trial.

A Phase IV clinical trial is done after the drug has been approved for marketing. This stage of testing usually compares the drug to a competing drug or looks at the drug in new types of patients. Long-term side effects of the drug are also monitored in this phase.

What types of study participants are needed?

Many types of people are needed to participate in research studies. Some studies need healthy persons. Other studies need persons with certain health problems. Persons of all ages and from all ethnic groups are needed. Why do people participate in research studies?

Every study is different, and the reasons people participate are different. Some reasons people take part in a study are:

  • To help others
  • To possibly improve their own health
  • To help advance science
  • To gain access to treatments before they become widely available
  • To access treatment options that might not be available outside of the research
What are the risks of participating in a research study?

The risks for each study are different. Some possible risks of taking part in a research study are:

  • The experimental treatment may not be as good as or better than the standard treatment.
  • If an experimental treatment is better than the standard treatment, it may not work for everyone.
  • New drugs and treatments may have side effects that are unknown to the researchers.
How are study participants protected?

  • The Federal government has rules to protect study participants.
  • All research studies in the United States must be approved and monitored by a group of people called an Institutional Review Board (IRB). The IRB is made up of scientists, doctors and community people. They review studies to help make sure that study participants will be assafe as possible.
  • Participants must be given complete information about the research study. They must also give their informed consent before taking part in the study.

These methods of protection do not eliminate all possibility of risk. They do help to ensure study participants will be as safe as possible. What is informed consent?

Before taking part in a study, each person will get a consent form that contains important written information about the study. It is important to read and understand the information in this form. The researcher or member of the research team will also talk to the person about the information contained in the form. The person should be sure all of his or her questions are answered before signing the consent form. A signed consent form is not a contract-a participant can leave a study at any time.

What questions should I ask before deciding to participate in a research study?

Before you decide to participate, you should ask as many questions as you need to in order to be sure you understand the study. Some questions you might want to ask are:

  • What is the purpose of the study?
  • Why am I being asked to take part in this study?
  • Who is paying for the study?
  • Who is doing the study and what are their qualifications?
  • Where is the study being done?
  • What kinds of tests or procedures will be done as part of this study?
How will the treatment, tests or procedures differ from those I would receive if I did not participate in the study?

  • How long will the study last?
  • How will my safety be monitored?
  • How will my privacy be protected?
  • What are the risks, side effects and/or discomforts of this study?
  • What are the possible benefits?
  • What are the results of any previous studies performed?
  • What are the alternative treatments and how effective are they?
  • Will I have to pay for any part of the study?
  • What expenses will my insurance carrier cover?
  • What happens if I am harmed by the study?
  • Is there follow up care available after the study?
  • Who do I contact if I have questions related to this study?

Below is a list of the clinical trials currently being undertaken by the Gastroenterology & Hepatology section at Tulane University.

If you or someone you know is interested in learning more about research please contact us at 504-988-3047.

Nonalcoholic Fatty Liver Disease (NAFLD)/Nonalcoholic Steatohepatitis (NASH):

  1. Genfit GFT505-315-1: A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor in Patents with Nonalcoholic Steatohepatitis (NASH) and fibrosis. (PI: Dr. Martin Moehlen)
  2. Allergan/Tobira Therapeutics 3152-201-002: Open-Label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Non alcoholic Steatohepatitis (NASH) (PI: Dr. Martin Moehlen)
  3. Allergan/Tobira Therapeutics 3152-301-002: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Non alcoholic Steatohepatitis (PI: Dr. Martin Moehlen)
  4. Bristol Myers Squibb MB130-068: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults with Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis (PI: Dr. Martin Moehlen)
  5. Bristol Myers Squibb MB130-069: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults with Nonalcoholic Steatohepatitis (NASH) and Compensated Cirrhosis (PI: Dr. Martin Moehlen)
  6. Celgene CC-90001-NASH-001: A Phase 2, Randomized, Double-Blind Placebo-Controlled, Multicenter, dose-finding study to evaluate the efficacy and safety of CC-90001 in subjects with Nonalcoholic Steatohepatitis (NASH) and Stage 3 or Stage 4 Liver Fibrosis (PI: Dr. Fredric Regenstein)

Hepatocellular Carcinoma (HCC):

  1. Bristol Myers Squibb CA2099DX: A Phase 3, Randomized, Double-Blind study of Adjuvant Nivolumab versus Placebo for Participants with Hepatocellular Carcinoma Who are at High Risk of Recurrence after Curative Hepatic Resection or Ablation (PI: Dr. Martin Moehlen)

Hepatitis C:

  1. Merck MK5172-017: A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects with Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in Prior Clinical Trial (PI: Dr. Martin Moehlen)
  2. Abbvie M14-222: An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267(ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (PI: Dr. Martin Moehlen)

Primary Biliary Cholangitis (PBC):

  1. CymaBay CB8025-31735: A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of Seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or an intolerance to ursodeoxycholic acid (UDCA). (PI: Dr. Martin Moehlen)