Cost of Clinical Trials

There are two types of costs associated with participating in a clinical trial through Northwest Georgia Oncology Centers‘ (NGOC) William S. Gibbons Cancer Research Institute:

  • Patient care costs
  • Research costs

Patient care costs: These are costs associated with providing medical goods and services to each patient. Usual care costs include doctor visits, hospital stays, clinical laboratory tests, x-rays, and any other medical costs that occur regardless of whether a patient is participating in a clinical trial or receiving standard treatment. These costs are usually covered by a third-party health plan, such as Medicare or private insurance.

Research costs: Research costs are costs that are associated with clinical trial participation at NGOC, such as data collection and management, research physician and nurse time, analysis of results, and tests performed purely for research purposes. Such costs are usually covered by the sponsoring organization, such as a pharmaceutical company. The sponsor and the participant’s health plan need to resolve coverage of these costs for particular trials. Be sure to consult with your physician about the financial aspects of any trial you are evaluating.

Health insurance companies and managed care companies decide which health care services they will pay for by developing coverage policies regarding the specific services. In general, the most important factor determining whether something is covered is a health plan’s judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exists in sufficient quantity, the plan may label the service as investigational.

Health care services delivered within the setting of a clinical trial are very often categorized as investigational and are not covered. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Thus, for some health plans, any mention of the fact that the patient is involved in a clinical trial results in a denial of payment.

Health plans may define specific criteria that a trial must meet before extending coverage. Some plans, especially smaller ones, will not cover any costs associated with a clinical trial, while other, larger managed care plans have recently announced at least partial coverage of costs associated with clinical research. Policies vary widely, but in most cases the best strategy is to have a doctor initiate discussions with the health plans.