Table 1.

Proposed Principles of Policy on Responsibility for Costs Associated with Clinical Trials

Principle
To ensure language consistency, the terms standard of care costs, usual care costs, and routine care costs should be abandoned and replaced with any test, procedure, medicine, or other intervention that is for “the direct clinical management of the patient” or that is “reasonable and medically necessary” to ensure safety.
Insurance plans should include coverage for clinical trials that have therapeutic intent and offer a reasonable possibility of benefit to the patient.
Insurance plans should cover trial-associated costs for items and services required in “the direct clinical management of the patient” and for those that are “reasonable and medically necessary” to ensure safety.
Sponsors should cover trial-associated costs for the investigational items, tests or services themselves and for services that are provided solely for the purpose of data collection and analysis.
As an integral part of the trial design, a coverage analysis should identify payment for each item, test and service required by a clinical protocol as a sponsor responsibility or as a patient or insurance provider responsibility.