Think about the most common medical procedures and treatments… those that provide relief to millions every day. They all have one thing in common. They were all the result of medical research.
At Gastroenterology Health Partners Research, our goal is to explore new treatments and new approaches that can improve the digestive health and quality of life of the people and communities we serve… and in doing so, make those new solutions available to people everywhere.
Our primary focus will be on clinical trials — research studies in which volunteers participate — typically to determine the effectiveness of a new drug in treating disorders of the digestive system, but also to test potential new procedures.
These trials may compare the benefits experienced by those who are treated with the new drug or procedure to those who receive an existing drug or procedure, or who receive no treatment at all.
For those who are experiencing difficulties with their digestive systems — especially those for whom existing treatments have proven to be less effective than they might have hoped — participation in a clinical trial offers a number of benefits.
Foremost among these is the opportunity to be a part of the process of identifying new, more effective treatments. The possibility of gaining access to an effective new treatment, coupled with the knowledge that you may be helping to pioneer that treatment for thousands or even millions of others, can be positive and powerful incentive to take part in a study.
There is also often a financial benefit for participants in a clinical study. When testing a new drug, for example, the cost of all lab work, doctor visits, medications and supplies related to the study are typically paid for by the company sponsoring hte study, not by the patient. This allows the participants to potentially benefit from the treatment at little or no cost.
HOW A CLINICAL STUDY WORKS
It Starts with an Idea
Nearly every clinical trial begins as an idea in the laboratory. Researchers test new therapies or procedures in laboratories and conduct preliminary, non-human studies first. Promising treatments move into clinical trials to gather information about the proposed treatment — especially risks and effectiveness.
Designing the Protocol
For every clinical trial, a plan known as a protocol is designed to safeguard participant’s health and answer specific research questions.
A Protocol Describes:
Who is eligible to participate in the trial
Specific details regarding:
How long the study will last
What information will be gathered
Clinical trials at GHP Research are sponsored or funded by various organizations or individuals, as well as federal agencies such as the National Institute of Health and the Department of Veteran Affairs.
For every clinical study, there is a GHP research team with a principal investigator (PI), typically a doctor. Members of the team regulary evaluate the participant’s health to assess the study’s safety and effectiveness.
Most clinical trials in the U.S. are approved and monitored by an Institutional Review Board (IRB). The role of the IRB is to ensure that any risks are minimal, and are worthy any potential benefits.
An independent committee, the IRB is made up of physicians, statisticians, and members of the community. Their job is to ensure that clinical trials are ethical and that the rights of participants are protected.
Informed consent means providing potential participants with the key facts about a clinical trial before they decide whether to participate. That process of informed consent continues throughout the study, with additional information provided as it becomes available.
Before someone decides to participate in a clinical trial, members of the research team explain the details of the study.
The potential participant is also provided with an informed consent document that includes details about the study. This covers the purpose of the study, how long it is expected to last, what procedures will be required, risks and potential benefits, how to obtain additional information and so on.
Once this process is complete, it’s up to the potential participant whether to sign the document and take part in the study.
It’s important to understand that informed consent is not a contract. Volunteers may decide to withdraw from the study completely or to refuse paticular treatments or tests at any time. This may, however, make them ineligible to continue the study. Withdrawing from the study does not affect the patient’s routine care.
PHASES OF CLINICAL TRIALS
Performed with a small group of people (20-80) to evaluate safety and identify side effects.
Performed with a larger group (100-300) to determine effectiveness and to further evaluate safety.
Administered to large groups (1,000-3,000) to confirm effectiveness, monitor side effects, compare it with other treatments, and collect information tha twill allow it to be used safely.
After FDA approval and release to the public, researchers track its use to learn more about risks, benefits, and optimal use.
Gastroenterology Health Partners Research only conducts Phase II-IV trials.
Interested in GHP Research?
If you believe you might be interested in participating in clinical trials related to digestive health conducted by Gastroenterology Health Partners Research, talk with your doctor.