A clinical study involves research using human volunteers that are intended to add to medical knowledge. Clinical studies are often categorized into two groups:
Observational studies where participants are followed for a period of time to better understand a disease process or population.
Clinical trials aim to reduce bias by grouping participants into different treatment comparison groups by a randomized draw process.
Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, research coordinators, technicians, and other staff.
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health. One of the goals of the Foundation for Vision Research is to be able to fund our own clinical studies which will help us better understand and treat problems found especially in West Michigan.
A clinical study is conducted according to a strict plan called the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information:
The reason for conducting the study
Who may participate in the study (the eligibility criteria)
The number of participants needed
The schedule of tests, procedures, or drugs and their dosages
The length of the study
What information will be gathered about the participants
The clinical trials that the Foundation for Vision Research participates in are all located at 5030 Cascade Road SE, Grand Rapids Michigan at the site of Retina Specialists of Michigan.
The length of a clinical study varies, depending on what is being studied and the protocol. It can be less than a month or as long as many years. Participants are told how long the study will last before they enroll.
Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll. The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Our research coordinators can help determine if you are a good fit for a particular trial.
Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study by including the risks, benefits, and alternatives to being in the trial. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.
Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document.
In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).
Various Federal agencies, including the Office of Human Subjects Research Protection and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
- Please contact one of our clinical research coordinators at (616) 954-2020.