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:
  • Tests
  • Medications
  • Procedures
  • Dosages
• 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.

The Team

For every clinical study, there is a GHP research team with a principal investigator (PI), typically a doctor. Members of the team regularly evaluate the participant’s health to assess the study’s safety and effectiveness.

IRB Review

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.

Phase I

Performed with a small group of people (20-80) to evaluate safety and identify side effects.

Phase II

Performed with a larger group (100-300) to determine effectiveness and to further evaluate safety.

Phase III

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.

Phase IV

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.