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.