Clinical Trials 101
What’s involved in a clinical trial?
If you are eligible, you may undergo a series of visits, which may include office visits, virtual visits, questionnaires, tests, procedures, medications, and/or labs, depending on the specific trial. You will always be able to contact someone and receive a timely response while enrolled.
Is it safe?
Patient Safety always comes first! The FDA requires extensive testing and data before allowing Clinical Trials in human participants. All participants are overseen by a physician investigator and a study coordinator, and typically receive a higher touch experience compared to a normal doctor’s visit. Prior to participating in a study, you will be evaluated to ensure you qualify, and you will receive details about risks, benefits, and expectations.
What are the Types of Trials?
The two broad types of trials are observational and interventional. Observational trials involve collecting data. Interventional trials typically have a medication, device, diagnostic, or procedure that is being investigated for use.
Pharmaceutical trials are classified by phases as follows:
Phase 1: First use in humans to test for safety. These typically take place in an inpatient setting for monitoring purposes and are conducted on “healthy patients”. Prior to starting human trials, the FDA requires extensive “pre-clinical” testing and data from non-human subjects before proceeding.
Phase 2: Testing for safety and initial testing for effectiveness (efficacy) in treating a condition. These are typically done in an outpatient setting like a doctor’s clinic.
Phase 3: Testing for safety and efficacy in a larger, more diverse patient population and geographic area. This is the final, or “pivotal” phase prior to receiving an approval decision from the FDA.
Phase 4: Also known as a “post-market” study, these are long term studies to collect more data after a drug is FDA approved and available in the market.
What is the cost?
That’s the best part! Not only are you provided with medications and/or procedures at no cost, the sponsors of these trials compensate you for your time and travel in the form of stipends. No insurance, or high-deductible plan? It doesn’t matter– your insurance company does not usually even come into the picture.
What Happens after a Trial is Complete?
Generally, after a sponsor collects all trial data, they will submit it to the FDA for a decision on approval or Depending on the specific study, you will receive further details
How do I Participate?
Contact Us for details on the Currently Enrolling Studies