What are Clinical Trials (or research studies)?
Clinical trials are designed to evaluate whether a new medication or device is safe and effective for humans. Strict regulations and standards are implemented to ensure ethical conduct of the study, safety of participants, and valid results. Clinical trials are the last stage before a new medication or device can be put on the market and sold to the public.
Why should I participate?
Participation is vitally important in bringing new and improved medications to people who need them. Individuals should consider participating because participation is a way to help society, receive free study-related medical care and medication, and earn extra money.
Will I be compensated?
Many studies do compensate you for participation. The amount of compensation is varied between studies.
How is my safety protected?
Participants’ safety is protected by many different ways. First, prior to participating, each participate is provided an informed consent. This document provides information about the study to the potential participant. The participant is given time to read the informed consent and given the opportunity to ask questions. This allows the participant to make a well-informed decision regarding whether or not he/she would like to participate.
Secondly, each drug and device trials that are regulated by the FDA must be approved, reviewed, and monitored by institutional review boards (IRB). The sole purpose of IRBs is to protect the rights and safety of clinical trial participants.
And finally, the FDA regulates each trial and have the authority to determine if the sponsor and/or research site’s are protecting participants.
Can a participant decide to stop participating in a trial before it’s over?
Yes. Your participation in a clinical trial is completely voluntary. You may discontinue participation at any time during a clinical trial. It is best to communicate this desire with the clinical trial staff so that end of study procedures can be completed and post-participation information can be provided.
What does Phase I, II, III mean?
Phase I is to determine dosage tolerability in humans and to see how the drug is metabolized.
Phase II trials involve the testing of many more people to determine how the medication works in the body, to determine if the medication works for the condition for which it is intended, and to define side effects, since by this phase, side effects are typically known.
Phase III trials typically compare the study medication to other commonly used medications.
Placebos may be used in Phase II and III trials. This is when some people participating in the trial are given the study medication, and some people participating in the trial are given a safe, inactive substance that is made to look like the study medication.
What is a Placebo?
A Placebo is a comparator medication that is safe, inactive, and looks like the study medication.