CLINICAL TRIALS


The clinical trial is a mainstay of cancer research.  It is a highly structured, strictly regulated process to test newly developed cancer drugs, medical devices, laboratory or imaging procedures, or new uses for standard therapies.
Each phase represents a different stage in the development of a new treatment.  In Phase I, a new drug or technique is being tested in humans, usually for the first time.  It has been proven safe in animal testing.  A Phase I trial is the next step in determining how much can be safely given, at what speed, how long the drug remains in the body, and what are the most common side effects in a human population.  How the drug effects tumors is also evaluated.  Usually there are only a small number of people in Phase I trials.  Phase II trials follow up what is learned during Phase I.  Safety is further established, more people are enrolled, and a greater focus is placed on effectiveness of the therapy.  Finally, the Phase III trials begin.  These are your typical, “randomized, controlled trials” that compare the new therapy to the current standard treatment to see which one works better.  These trials usually enroll many patients, typically in the thousands.
Absolutely not!  Extensive research has preceded the availability of a clinical trial.  The new investigational agents  being tested are usually patterned after older, proven therapies, only with slight alterations to make them more efficient, less toxic, or easier to take.  The way the new drug will behave and possible side effects have already been tested using different models (usually animal) in the lab.
The routine standard of care while on a clinical trial are typically covered by a patients insurance, however patients are still required to pay their contractual insurance co-pays, deductible, and/or co-insurance.  Patients are still required to pay for their prescription drugs, according to their own medical insurance pharmacy benefits plan.

The study drug itself is provided free by the trial sponsor, and the collection of research data are paid by the clinical trial sponsor.    However, the clinical trial sponsor does not pay for routine standard of care medical costs.       However, a clinical trial sponsor may reimburse for travel and hotel for patients who travel long distances to participate.

In 1991 President Clinton issued an executive order requiring medicare to cover the routine standard of care while on clinical trials.    In 2000, North Carolina State Legislature passed a law requiring private insurance companies to cover routine medical care while on clinical trials.    In 2010, the enactment of the Federal  Affordable Health Care Act requires all private health care insures to cover the routine medical care while on clinical trials.

Clinical trials are highly regulated and require extensive documentation.  Though clinical trials are necessary to advance our understanding of cancer treatments, your safety and welfare are our top priority.  Such studies are highly regulated to ensure everyone involved is aware of the risks and benefits of the trial, and to make sure all results across trial sites are consistent, unbiased, and accurate.
Every clinical trial is different.  We try to make enrollment and participation as easy as possible for patients.  Your eligibility for a trial is ultimately the decision of the sponsor (usually the drug company).  At CBI, we have dedicated clinical trial coordinators who stay up-to-date on the status of each of our trials.  Clinical trials open and close monthly, so we keep you updated as new information is received from the various participating sites and sponsors.  The coordinators will be your guide through the process from your first office visit to your last infusion and beyond.  Though each trial, each patient, is different, you can always expect enthusiasm, advocacy, and professionalism from our staff as we work to find the best trial options for your individual case.