What are Clinical Trials?
A clinical trial is a scientific study to evaluate new treatments, which may include drugs, diagnostic procedures or a combination of new therapies, to determine if they are safe and effective. These trials help determine what new treatment options may be most effective and whether patients can benefit from them. Nearly all cancer drugs being used today were once tested through a clinical trial, which shows the vital role these studies play in improving treatment and outcomes.
Clinical trials are generally divided into three phases or stages. New treatments must pass through all three stages before the Food and Drug Administration (FDA) will approve its use as standard therapy.
- Phase I trials determine the safety of a new therapy and generally evaluates the route of administration (oral, intravenous or injection), dosage and frequency. This phase does not evaluate the effectiveness of the therapy and as a result typically enrolls very few patients.
- Phase II studies determine the effectiveness of a treatment and typically focus on specific cancer types. This phase also generates more data on the safety of a given medication.
- Phase III trials evaluate the new therapy as compared to a standard therapy to determine which is most effective and the safest option for the patient. There are a large number of participants in phase III trials and many clinics and centers test therapies in this phase at the same time. Typically patients are randomly selected to receive either the standard therapy or the new therapy being evaluated.
The Jones Clinic is renowned among some of the nations’ largest pharmaceutical companies because of our comprehensive tracking and reporting, providing vital data on these groundbreaking studies. We believe a strong foundation in research and cutting edge clinical trials ensure better outcomes for our patients.
“We have come to depend on The Jones Clinic for their outstanding effort and commitment to clinical trials. They have enrolled more patients in our Sponsor’s trial than any other site in the US, while delivering quality data in the process.” Stacey S., inVentiv Health Clinical