About Clinical
Studies
Participating in a Clinical Study
One of the purposes of the clinical trial is to evaluate the safety and effectiveness of a potential medication, and there are several stages of testing before it can be approved. Without enough volunteers to participate in a study, the study medicine's development may be stalled or even abandoned, and the study medicine may not have the opportunity to be evaluated well enough to become available. Every study follows an extensive and carefully monitored process that focuses on the safety of the participants.
Some things to know about clinical trials
- One of the purposes of the clinical trial is to evaluate the safety and effectiveness of a potential medication, and there are several stages of testing before it can be approved.
- In the US, the FDA requires that a potential therapy be tested before it can be approved to be available for patients with a specific disease or condition.
- Without enough volunteers to participate in a study, the study medicine’s development may be stalled or even abandoned, and the study medicine may never become available.
- Every trial follows an extensive and carefully monitored process that focuses on the safety of the participant.
- All clinical trials have guidelines or eligibility criteria, which determines whether a potential participant can be part of a trial.
- To determine if you meet the eligibility criteria for a study, the study staff will ask about your medical history and conduct a physical examination.
- Study staff may also need to conduct some preliminary tests, like blood tests, because results of these tests may also qualify you for the study. Your doctor can advise you about the eligibility criteria.
10 Questions to Ask Your Doctor About Participating in a Clinical Study
What is the purpose of the study?
The research team provides an informed consent document, which includes details about the study such as its purpose.
What is informed consent?
Informed consent is designed to discuss with the study participant study details, including potential risks and benefits, before they decide whether to participate or not. It is provided in a document that a participant is asked to sign.
Who will pay for the study treatment during the course of the study?
Ask your doctor which costs may be covered during your participation in the trial; for example, sometimes travel expenses for study treatment visits may be included.
Do I meet the eligibility criteria?
Eligibility criteria are based on factors such as age, gender, type and stage of disease, previous treatments, and other medical conditions you may currently have or had in the past.
What kind of tests will I need?
The informed consent document provides details about tests, procedures, medications, and dosages, which can be discussed with your doctor and the research team.
Will I need to discontinue my regular treatments?
Depending on the study protocol, you may or may not be able to continue on your current treatment. Your doctor can discuss this with you.
What are the potential side effects that I can expect and how will I handle them?
There may be side effects that are unknown. A clinical trial is one way to determine what side effects will occur in people receiving the investigational medication for their disease. Your doctor can discuss this with you.
How long will the trial last?
Along with a study treatment period, clinical studies often have a follow up period where participants are still being closely monitored. The informed consent document will outline the duration of both study treatment and follow up.
How will it be determined whether the study treatment is working?
For the duration of the study, participants will be monitored. The study protocol outlines how the effects of the investigational medicine will be assessed.
Can I leave the study after I join if I want to?
Participation is voluntary and you can leave the study at any time. Should you leave the study, you will continue to receive the standard of care treatment. Ask about any follow up or precautions that may be recommended after withdrawing from a study.
4 Reasons to Enroll in a Clinical Trial
1
There is no available treatment, or the currently available treatments have not worked for you
Potentially gain access to investigational medicines
2
Receive regular medical follow up
When you are a participant in a clinical trial, expect regular check-ups
3
Play a more active role in your healthcare
By participating, you may learn more about your disease
4
Help advance the knowledge and treatment of disease
Help others by contributing to medical research
