Frequently Asked Questions
Clinical trials are conducted to collect information and data regarding a new drugs safety and efficacy or new device development. There are several steps to gaining approval for a new medication or device including years of research and development and approval from the FDA (Federal Drug Administration) once approved by the FDA then the clinical research process can begin.
There are specific guidelines about who can participate in a clinical trial. A Volunteer must qualify for the study by “inclusion criteria” and disallow volunteers from participating if they meet “exclusion criteria”. Our helpful staff can answer all of you questions about the trial and inclusion and exclusion criteria.
If a volunteer is selected by inclusion criteria they may continue with Informed Consent and be grouped in 2 groups, Active group or placebo group. Research staff may or may not know if the participant is in the active or placebo group.
Informed Consent is the process of giving consent to participate in the clinical trial, purpose of the trial, procedures involved, potential risks and benefits with the volunteer and the ability to ask all questions related to the study process.
No you do not need insurance to participate our services are free of cost. You may also receive compensation for time and travel.
Clinical trials can vary in length of time based on certain criteria some may last 2-4 weeks while others can last weeks to years. This information will be provided for you in your clinic visit.
The Volunteer provides clinic staff with their medical history, any medications they are taking and may require blood work or other testing. Volunteers will also meet with our physicians for a checkup/physical and capability to ask any questions they may have.