Costs of a Clinical Trial

Many people wonder, what are the costs associated with enrolling in a clinical trial? The clinical trial sponsor pays for the costs associated with the treatment under study, such as drugs being compared, and will pay the extra costs associated with additional testing or doctor visits required by the trial’s protocol. Routine patient costs, such as doctor visits, hospital stays, laboratory tests, are the costs of medical care you would have received if you were not in the trial. Some health insurance plans may not cover routine patient care costs in a clinical trial. You should work with the clinical trial research coordinator to help you find out if routine costs are covered by your insurance plan. To try to help get an insurance company to pay for a trial, the National Cancer Institute, suggests that you ask the research coordinator to provide you with medical literature that show potential benefits of the treatment tested, a letter of clinical necessity, documentation from the researchers explaining the clinical trial, and support letters from an advocacy group to submit to an insurer.

Health insurers use several criteria to determine whether to cover costs of a clinical trial.

According to the National Cancer Institute:

  • If you live in a state that requires coverage for clinical trials. For more information go to States that Require Health Plans to Cover Patient Care Costs in Clinical Trials
  • If the policy allows coverage of routine patient care in a clinical trial
    That the trial is medically necessary, which is decided usually on a case-by-case basis
  • If the trial is a phase III, the insurer might cover it because the treatment has already had success in many people
  • If the routine costs of care in the trial are comparable to the costs for standard treatment
  • The trial is sponsored by the National Institutes of Health or one of the groups it funds.

There are also resources available from not-for-profit organizations to help with the costs of clinical trials. You may be able to find assistance by searching through this directory on the NCI website.