Why should I take part in a clinical study?
Participating in a clinical study can open up new opportunities for treatment options that would otherwise be unavailable to you as they may not have been FDA approved and around publicly available. Your participation is also benefitting the advancement of science and new treatment options to come.
How do I qualify to participate in a clinical study?
The criteria for taking part in a clinical trial is unique to each specific trial. Your doctor will work together with the research team to conduct an initial screening to see if you are a good candidate for the trial. Criteria can include age, gender, pre-existing health conditions, medical history and race.
What is the risk of participating in a clinical study?
Before participating, your team will walk you through the risks involved for the study before signing your informed consent. Because this is a clinical trial, many of the risks may be unknown. You will be given time to discuss with your doctor and ask questions.
What does “blinded” study mean?
A “blinded” study means that one or more participants won’t be aware of the drug or device being used in the clinical study to avoid bias towards the outcome.
What does randomization refer to?
Randomization refers to the random process in which your treatment is assigned—whether you receive the investigational treatment or the placebo. This process is completed by a computer. Your doctor does not influence this assignment.
Why is there a placebo?
A placebo is used to that there is a way to compare the investigational drug’s effectiveness. These studies are “blinded” and you won’t know if you are getting the placebo or the investigational drug.
Do I get paid for taking part in a clinical study?
For participant making frequent research visits, we offer a small stipend to cover travel and time expenses. This can be explained in greater detail during the informed consent process.
How long do clinical studies last?
The timeline of each study is unique and will be discussed during the informed consent process. Participation in the clinical study is voluntary and you are welcome to stop at any time.
The Institutional Review Board (IRB), comprised of a group of medical and non-medical professionals, is responsible for safeguarding the rights and welfare of human subjects by reviewing and approving the protocol and informed consent by following the FDA rules. It is. This group is also required by the FDA to do periodic review of ongoing research studies.
What are the different phases of research?
- Phase I – Initial studies to gain early evidence of effectiveness and potential side effects; may include healthy participants and/or patients.
- Phase II – Controlled clinical studies are meant to evaluate the effectiveness of the drug for a particular condition under study, as well as determine the common short-term side effects and risks
- Phase III – If evidence has been gathered that suggests the effectiveness of a drug, expanded controlled and uncontrolled trials are conducted to gather additional information to evaluate the overall risk and benefit of the drug, and provide an adequate basis for physician labeling.
- Phase IV – Post-marketing studies to map out additional information including the drug’s risk, benefits, and optimal use.