Who runs a clinical trial?
Clinical trials are run and funded by sponsors. Sponsors can be organizations or individuals such as pharmaceutical companies, medical institutions, foundations, voluntary groups, and individual physicians. Clinical trials are usually led by a medical doctor who is called the “Principal Investigator.” And there is usually a team of people, called the “Research Team” who work on each trial. Clinical trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, community clinics and home visits.
Does the participant pay to be in a clinical trial?
The costs for the treatments and tests in the trial are covered by the research sponsor. This can include the treatment being studied and other treatments, such as blood tests, physical examinations, and imaging scans like X-rays.
However, there can be costs that are not covered by the sponsor. These may include time away from work, travel to and from the research site, child care coverage during study appointments, etc. In most cases, the research sponsors will provide trial participants with compensation to help pay for these costs. People who are considering participating in a trial can ask the research staff about any costs before agreeing to participate in a trial.
What are the benefits and risks of participating in a clinical trial?
Potential benefits of participation may include:
● Playing an active role in one’s own health care
● Gaining access to new research treatments before they are widely available
● Receiving medical services such as physical exams, blood tests, or imaging scans
● Helping others by contributing to medical research
Potential risks of participation may include:
● The possibility of unpleasant, serious, or even life-threatening side effects
● The treatment may not be effective
● The trial may require a great deal of time and effort, including trips to the study site, hospital stays, or complex dosage requirements
People who are considering taking part in a trial can discuss the benefits and risks of the trial with the research team.
What is a protocol?
A protocol is the plan that the clinical trial must follow. The protocol is carefully designed to protect the health of the participants and answer specific research questions.
A protocol describes:
● The Purpose of the Trial and Information Researchers want to Collect about Treatment
● The Length of the Study and Visit Schedule
● The Rules about Who May or May not Participate in the Trial (Inclusion/Exclusion criteria)
● The Schedule of Tests, Procedures, Medications, and Dosages
● Potential Risk and Benefits of the Clinical Trial