What is a clinical research trial?
Clinical research is conducted to gather important information and data about the safety and effectiveness of new drugs and devices being developed. Several stages exist in the trials process before a drug, or a device, can be sold to consumers. Before drugs are approved by the Food and Drug Administration (FDA) for human testing, a series of steps must be passed.
Why would a pharmaceutical company need to conduct research?
There are a variety of reasons why a pharmaceutical company would need to conduct research. Perhaps there is an existing drug on the market that treats one condition, and they want to test to see if it also treats other conditions. A company may test a generic version of an FDA approved drug, may test other doses of drugs, or different drug formulations.
Who is allowed to participate in a clinical trial?
Research volunteers who meet inclusion criteria, which is determined by the sponsor in collaboration with the FDA. The criteria could include age, gender, type and stage of the disease or condition, previous treatment history, or other medical conditions. If you have questions about inclusion criteria and if you qualify, it’s important to speak with our team of professionals.
What can I expect during the trial?
We first begin with the screening process, to ensure volunteers are eligible, according to the inclusion criteria mentioned above. Before you can be enrolled, the research team including doctors, nurse practitioners, nurses, and clinical research professionals will give you an informed consent document which includes specific details relevant to the trial. After meeting inclusion criteria and giving informed consent you will begin the study. Study visits are scheduled per the study protocol, and study procedures are performed.
How should I prepare for a clinical research trial?
Before volunteering, you should talk with your medical provider about your condition and your intent to participate. The types of questions our participants most often ask are:
- What is the purpose of the study?
- What kind of treatments and tests are involved?
- Has the drug been tested before?
- How long will the study last?
- What are the possible side effects?
- Is long-term follow-up care part of this study?
- Who is in charge of my care?
- How will I know if the experiment is working?
- What is the study compensation?
We are happy to answer and any all questions that you may have as a potential participant.
What are the benefits of volunteering for a clinical trial?
The top perceived benefit is your satisfaction in the advancement of science. Additionally, your condition MAY improve during your participation in the study.
If you have any additional questions, please don’t hesitate to contact us.