Clinical Trial FAQs
What is a Clinical Trial?
A clinical study is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical studies are an important step in making new medications and treatments available. These studies are used to verify if the drug works, is safe, and if there are possible side effects. All treatments which are currently available have undergone the clinical trial process.
Why Should I Volunteer for a Clinical Trial?
Volunteering to participate in a clinical drug study is a way you can contribute to understanding a disease and the development of new therapies. As a volunteer, you are an important link in a long chain of research and testing in the development of new medications for a broad range of health problems.
How do trials benefit the Volunteer?
You may help others by contributing to medical research. You may also gain access to help new treatments which are not available.
What is a drug study?
The development of new drugs is complex and multi-phased. Before any drug can be marketed to the public, it needs to undergo extensive research to ensure safety, optimal dosing, efficacy, and asses side effects and toxicity. New drugs are initially tested in animal studies and then undergo a multi phased human testing regimen.
•Phase 1: The initial human studies testing the drug in healthy volunteers.
•Phase 2: The drug is tested in patients who have the illness or disease for which the drug will be used. Phase 2 often helps to optimize dosing for drug.
•Phase 3: Similar to Phase 2 but usually involves many more centers and many more patients. These study results are submitted to the FDA to obtain approval for the drug to be marketed and sold to the public.
- Phase 2 and Phase 3 studies may be placebo controlled, i.e. some of the patients in the research study might not receive any active drug but rather a “sugar pill”. These studies are usually double blinded, i.e. neither the investigator nor the subject knows what is given (placebo or medication).
•Phase 4: Studies done on medications which are already approved for use by the public.
How is a Drug Approved for Testing?
The US Food and Drug Administration (FDA) generally have to authorize a drug company’s proposal to conduct a clinical study. Drug companies have to do years of laboratory research before any testing can begin in humans. It also takes many years for a drug to complete clinical study testing and become approved by the FDA.
Who can be in a Clinical Trial?
Both healthy volunteers and people with a specific condition are both required in the clinical trial process. This depends on the phase the drug testing is in. Each study also has its own specific criteria such as age, sex, medical condition etc. to determine if you qualify. A clinical research coordinator can review some questions about your medications and medical history to determine if you may qualify.
What is an Informed Consent?
An informed consent must be signed prior to participating in a clinical study. This ensures that the volunteer has all the information that they need to make an informed decision about participating in a clinical study. This document includes details about the study such as its purpose, duration, required procedures, etc. The informed consent process also allows the volunteer to ask questions and to exchange information freely with the clinical investigator.
How is the Safety of the Participant Protected?
The ethical and legal codes that govern medical practices also apply to clinical trials. In addition, most clinical research is federally regulated and has built in safeguards to protect the participants.
Can a Participant Leave a Clinical Trial after it has Begun?
Yes. A participant can leave a clinical trial at any time. If a participant decides to withdraw from a trial the participant should let the research team know about it and the reason for leaving the study.