GI Trials

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FAQs

WHAT IS A CLINICAL RESEARCH STUDY?
A clinical research study is scientific investigations in which people can help doctors find new and better ways to prevent, detect, diagnose, control, treat illnesses and improve healthcare.  These studies are a vital part of the process by which new treatments are approved for use. The Food and Drug Administration (FDA) requires clinical trials on all medication before they will approve a medication for public use.
 
WHY PARTICIPATE IN CLINICAL RESEARCH?
Research participants take an active role in research by helping doctors and scientists learn about various health problems and diseases. Knowledge gained through these research studies may help others live longer, healthier lives.  Participating might help you directly by giving you access to an investigational drug or procedure you would not otherwise be able to receive at that time.  
 
WHO CAN PARTICIPATE IN CLINICAL RESEARCH?
Each clinical research study has different inclusions and exclusions that determine whether a person can participate. The criteria are used to help researchers answer the study questions and to ensure the safety of all participants. Depending on what the study is testing, inclusion and exclusion criteria may include illness, health history, past or current treatment, age or sex, address (A person living too far from where the study takes place may not be eligible to participate). Sometimes a study will be looking for people with a particular medical condition, and sometimes a study will only want healthy participants. Talk to one of our experienced Clinical Research Coordinators to find out if you are eligible for a particular study.
 
WHAT HAPPENS DURING A CLINICAL RESEARCH TRIAL?
First, our Coordinators will thoroughly explain the study to you, what will be required of you, and what the potential risks and benefits might be.  Some clinical research trials may require that you complete a questionnaire, while others may require that you have a blood test or take a certain medication. Some research studies may involve more extensive treatment.
 
Once you have a good understanding of the study and are interested in participating in the study, you will be asked to sign a consent form. You will work with a research group that will consist of doctors, physician assistants, clinical research coordinators and other health care professionals who will provide your care, monitor your health, and give you specific instructions about the study.  It is important for you to follow the instructions, attend all doctor visits, take all tests and medicines as instructed, and complete logs or answer questionnaires. This will ensure the trial results are as reliable as possible.  

WHAT IS INFORMED CONSENT?
Informed consent is the process of learning the key facts about a clinical research trial before you decide whether to participate. It is also a continuing process throughout the study to provide information for participants.  You will be included in a written consent form that you can take home to read and discuss with family and friends. The consent form includes information such as details about the study, the length of the study, possible risks and benefits, and the tests you may have to undergo.  Once you decide to participate our Coordinators will ask you to sign an informed consent document.

Informed consent is not a contract, and the participant may withdraw from the trial at any time.

WHAT ARE THE POSSIBLE RISKS AND BENEFITS OF RESEARCH STUDIES?
The risks and benefits of each study are dependent on the study itself. All the risks and benefits will be listed in an informed consent document and will be explained to you in detail by the researcher who is conducting the study.

Some potential benefits of participating in a clinical research trial may include:

  • Expert health care provided by our physician/physician assistant during the study.
  • Access to new research treatments before they are widely available.
  • Play a more active role in your own health care.
  • An opportunity to make valuable contributions to medical research.
  • Possible compensation for participation in the study.  Free treatment for many clinical trials, including the medicine being evaluated, doctor visits, physical examinations, laboratory tests, outpatient procedures and other diagnostic tests.

HOW ARE MY SAFETY AND RIGHTS PROTECTED WHILE I AM PARTICIPATING IN A STUDY?
Any clinical study that is conducted at Digestive Health Center by an independent Institutional Review Board (IRB) whose job it is to ensure that patients’ rights are protected and that a study does not present undue risk.  Strict federal mandates are followed to ensure that all studies are conducted safely and ethically.  Any patient who is considering participating in a clinical trial is required to sign a consent form.  This document details the purpose of a study, the risks involved, any potential benefits as well as alternative treatments available if they chose not to participate.  Potential participants must pass a screening period to ensure they meet all requirements.

OUR RESEARCH STAFF
We have a dedicated research department whose team members are required to receive additional training on the safe and ethical conduct of clinical research and certification in the protection of human subjects’ safety.  Our research coordinators work very closely with our study participants and physician/physician assistant to ensure each study is conducted in compliance with the study protocol and all local and federal mandates.
 
WHAT SHOULD YOU CONSIDER BEFORE PARTICIPATING IN A CLINICAL RESEARCH STUDY?

  • Why is the research study being done?
  • Who will be in it?
  • How long will the study last?
  • What tests or procedures are involved?
  • Will you be able to continue seeing your own doctor?
  • Is there any cost to you?
  • Will you be paid to participate in the study?
  • Who will pay for the study drug and procedure?
  • Is hospitalization required?
  • Could the research hurt me?
  • Does anyone receive money for your participation in the study?
  • What are your other choices if you decide not to take part in the study?
  • Will the new treatment help you more than the regular treatment?
  • Could you get a placebo or a substitute?
  • What could happen to you if you take part in the study? Has anyone reported any bad effects? How serious were they?
  • Could your condition get worse during the study? What happens if it does? If your condition worsens, will you be told? How?
  • Can you stop participating in the study if you change your mind? Is there any danger to you if you stop participating?
  • What will happen to you after the study?
  • Will you be told the results of the study?
  • Who pays if I’m unexpectedly injured in the study?
  • Are there any patient advocates you can talk to? The advocate should not be employed by the clinic or laboratory that is doing the research study.
  • Who do you contact for information about the study?


WHAT ARE THESE PHASES OF CLINICAL TRIALS?
Each clinical trial is conducted in 4 basic stages or phases explained in detail below:

Phase 1 or early stage clinical trials: These are the earliest trials in the life of a new drug or treatment tested on humans. The purpose of this phase of medical research is to determine the safety of the drug dose, the side effects of the medication and how the body clears (excretes) the drug and the pharmacokinetics of the drug.  Phase 1 trials do have some amount of risk involved due to the fact that not much is known about the effects of the drug on humans. Hence, these trials usually include a select few participants (usually 20-80 or less) and the inclusion/exclusion criteria for these studies are very strict. These studies prefer to include only healthy volunteers for such studies. Since the amount of risk involved is high, the compensation given to the trial participants is high for phase 1 studies.  Only once the results of the Phase 1 study are known will the Phase 2 study commence.

Phase 2 studies: About 70 out of every 100 new treatments tested at Phase 1 move to Phase 2 trial.  The purpose of the phase 2 clinical trial is to determine the right dosage of the drug and also establish the safety of the drug on the people actually showing the symptoms that the drug is reported to cure.  Phase 2 studies are conducted on a larger group of people (100-300), preferably those who are actually suffering from the disease condition which the drug aims to treat.  This phase can last several years.

Phase 3 clinical trials:  Once the drug proves effective and safe in the phase 2 trial it is moved further to the phase 3 trial. These are long term trials that include a large population of participants usually trying to include the various segments of   the population (men, women, children, etc.).  These clinical trials intend to confirm the effectiveness, efficacy, and safety of the study drug and monitor the side effects of the drug. The basic purpose of these studies is also to verify the benefits and risks involved in the use of the new drug as compared to that of the already established modes of treatment.
 
A drug is moved to the next phase only if the drug proves to be significantly more beneficial than established means of treatment.  The U.S. Food and Drug Administration will consider the results of clinical trials when determining whether to approve a new drug.

Phase 4 clinical trials or advanced stage trials:  Phase 4 trials takes place after the U.S. Food and Drug Administration approves use of a drug.  These studies are conducted on drugs or treatments that already have approvals and are being prescribed by doctors. These studies are basically conducted to collect extra efficacy data and market the drug as a better means of treatment than the other available methods of treatment.
 
How does this information matter to you as a prospective participant…well, with each progressing phase of clinical trial, the risk involved reduces. Thus phase 1 trials are the riskiest and also pay the most (for time) whereas phase 4 trials are the safest, with proven medical benefits, (but rarely have any monetary benefits involved).
 
HOW CAN I FIND OUT ABOUT CLINICAL TRIALS?
To find out more about clinical trials ask one of our Clinical Research Coordinators who can answer your questions and screen you for the appropriate clinical trial.  Information about our current clinical trials can also be found on our website.