For inquiries regarding participation in a clinical trial, please contact the Trinity Health Office of Research & Innovation – West Michigan at 616-685-5597.
A clinical trial is a research study that involves human participants to evaluate new approaches to the prevention, diagnosis and treatment of a disease. These new approaches can include new therapies, medicines or devices. Clinical trials help doctors find out if these new approaches are safe and if they are better than treatments already being used.
One way of classifying clinical trials is by their purpose:
Some clinical trial terminology you might come across:
Most clinical research involves testing in a series of steps, called phases. The different phases are:
Each study has its own guideline of who can participate. These guidelines are made up of factors called inclusion and exclusion criteria and these vary based on the study protocol; a study protocol outlines how the clinical research trial will be conducted.
The inclusion criteria are the factors that allow someone to be involved in a clinical trial and the exclusion criteria are the factors that prevent someone from being included. Eligibility guidelines can include age, gender, type and stage of disease, previous treatment history and other medical conditions.
Being specific and selective about who participates in a clinical trial helps produce more reliable results. Before you can be included in a clinical trial you have to qualify for the study.
Biorepositories are "libraries" in which bio specimens are stored for future use in research. These repositories also collect information regarding the patient who provided the specimen. They are critical to enabling modern molecular-based research that will help drive the development of new diagnostics and therapies.
Bio specimens are biological materials from people (such as tissue, blood, plasma, and urine) that can be used for diagnosis and basic research. When patients undergo procedures such as a blood draw, biopsy or surgery in which a specimen is removed for diagnostic or therapeutic purposes, it is often possible for a small amount of residual specimen to be stored and later used for research. Many patients have given consent for their bio specimens to be used in research, in the hope that the resulting knowledge might help other patients in future years.
Before someone can enter a clinical trial, they must sign an informed consent document. This document provides detailed information about the study and will discuss the risks and benefits to the participant. The information in the document will be explained to the participant by the research team. If you decide to participate in the trial, you will need to sign the informed consent document and you will receive a signed copy. It is NOT a contract and you are allowed to leave the study at any time.
Each hospital or research center has an IRB which is an FDA-mandated committee consisting of health care professionals, scientists and non-medical people from the local community who review all clinical research trials to ensure the participant safety is protected, personal rights are respected and that all participants are fully informed about the trial. The IRB must approve all clinical trials before they can start.
Participation in a clinical trial is completely voluntary and you are allowed to leave a study at any time. Leaving the clinical trial early will not compromise or affect future medical care. Participants that need to withdraw should notify the research team and provide a reason for leaving.
Participating in a clinical trial should not replace the care you receive from a primary physician. The members of a research team serve as an additional support for your current treatment and do not replace the primary physician.
For inquiries regarding participation in a clinical trial, please contact the Office of Research & Innovation at 616-685-8888.