Digestive Clinical Trials

There are five types of clinical trials offered at Houston Methodist:

• Treatment trials – These test experimental treatments, new combinations of drugs or test new approaches. 
• Prevention trials – These test new approaches to prevent disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals or lifestyle changes. 
• Diagnostic trials – These are conducted to find better tests or procedures for diagnosing a particular disease or condition. 
• Screening trials – These test the best way to detect certain diseases or health conditions earlier. 
• Quality of life trials – These explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Clinical trials are conducted in phases. Each phase has a different purpose and helps scientists answer specific questions.

• Phase I trials – These test experimental drugs or treatments in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects. These studies may or may not benefit participants.
• Phase II trials – These test an experimental study drug or treatment in a larger group of people (100-300) to see if it is effective and to further evaluate safety and learn how it helps the condition under study.
• Phase III trials – These test an experimental study drug or treatment in even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely.
• Phase IV trials – These are post-marketing studies that collect additional information including the drug´s risks, benefits and optimal use.

Along with benefits, there are potential risks and drawbacks of participating in a clinical research study, including:

• Your disease or condition may not get better with the experimental treatment.
• You may experience side effects or have a bad reaction to the study treatment you receive.
• You may be in the group that gets a placebo — a treatment designed to be inactive to provide the researchers with a control group. A placebo is like taking a sugar pill and will not cure a disease. Placebos are not used in cancer clinical trials unless they are given along with an active, standard drug.
• You may have to visit the doctor more often than you would for regular, standard care. The visits might involve having lab tests and procedures done.

Informed consent is a process in which you learn the important facts about the clinical trial to help you decide whether to participate. Researchers use this process throughout the study to provide ongoing information to the participants. 

After learning about the study, you will be able to ask the researcher or their research staff questions. You should only agree to take part in a study if you clearly understand the study and feel comfortable.

If you agree to take part in the study, you will be asked to read and sign an informed consent form. Signing the form does not require you to stay in the study. You may leave the study at any time during the study or the follow-up period.

If you decide to be in a study now and you change your mind later, that is okay. You just have to tell the study doctor or the study staff as soon as you change your mind.

Information about you and your participation in a research study will be kept as confidential as possible. Information will be given only to those who have permission to see your records.

This may include the group sponsoring the study and those who make sure the study is safe and carried out according to the research plan. Some studies are reviewed by the Food and Drug Administration (FDA).

With a cancer diagnosis, your doctor considers the full range of treatment options. For some patients, a clinical trial may be suitable.

You will need a referral from your doctor in order to participate in a clinical trial. If you may be eligible for a particular clinical trial, your oncologist will work with the research team to help you get started.

Someone from the research team, usually the principal investigator (the physician in charge of the study) or a trained staff member, will explain the details of the study to you.

The information they provide must include several pieces of information:

• Purpose or goals of the study
• Description of the study design, such as the use of placebos, controls and whether the study is conducted in a blind or double-blind manner
• Why the study is being conducted
• Information about the treatment being studied and how the treatment will be administered
• Exactly what your participation involves (the exact tests and procedures you will be required to undergo and the amount of time the study will take)
• Known risks and benefits of participation
• Alternative treatments that are currently available
• Contact information for the investigator
• Contact information for the Institutional Review Board
• Statement that your participation in voluntary and that you may stop or withdraw from the study without any penalty

During this discussion you should ask as many questions as you want in order to fully understand the details of the study. Take as much time as you need to make your decision. You may want to ask family members or friends to read the consent form.

If you decide to participate in the research study, you will be asked to sign the consent form. After you sign the consent form, you may be asked to take part in screening tests to make sure you qualify for the research study.

Researchers use a set of guidelines to help them select volunteers for the clinical research study. They want to make sure it is okay for volunteers to participate.