What is a clinical trial?
A clinical trial tests the effects of a medication, medical treatment, or device, on a group of volunteers. Clinical trials are an important step in making new medications available, as they help assess the drug’s safety, measure its ability to treat a condition, and determine possible side effects.
How is a drug approved for testing?
Typically, the U.S. Food and Drug Administration (FDA) must authorize a drug company’s proposal to conduct clinical trials on medication. Drug companies must do years of laboratory research before they can begin testing medicine in humans.
Who can be in a clinical trial?
Anyone can participate in a clinical trial, whether they are affected by the condition being studied or not. However, there are strict requirements specifying which trials may involve healthy volunteers, and which trials must involve patients with the condition being studied.
Every clinical trial has specific requirements for participation, such as age, sex, or medical condition. The physician conducting the trial will compare each volunteer’s medical history against the trial requirements in order to determine eligibility. Known risks and discomforts will be explained by the trial physician prior to beginning any study. However, there may be unknown risks as well, such as medication side effects. Trial procedures, risks, and benefits are explained to volunteers during the informed consent process.
What is informed consent?
Informed consent is the process of disclosing necessary information to volunteers before they agree to participate in a clinical trial. This process allows the volunteer to freely ask questions and exchange information with the clinical investigator, whose responsibility it is to ensure that informed consent is obtained from each research volunteer before that person participates in the research trial.
What is the Institutional Review Board?
The Institutional Review Board (IRB) consists of healthcare professionals and local community members who must review and approve a clinical trial before it begins. Because the IRB is focused on protecting the safety and rights of trial participants, it always reviews clinical trials.
Why should I volunteer?
Patients who participate in clinical trials help shape the future of healthcare. They also enjoy the following benefits:
- Experience new treatments or procedures, not yet available on the market
- Help improve treatment for future patients
- Receive closer monitoring of lab and procedure results
- Receive compensation for participating, without providing any financial or insurance information
How can I become a trial volunteer?
To learn more about participating in clinical trials, contact Saginaw Valley Medical Research Group at (989) 497-5851 or email@example.com.