What are eligibility criteria, and why are they important?


Every clinical trial has a protocol, or action plan that describes what will be done in the trial, how the trial will be conducted, and why each part of the trial is necessary. The protocol also includes guidelines for who can and cannot participate in the trial. These guidelines, called eligibility criteria, describe the characteristics that all interested people must have before they can take part in the trial.

Eligibility criteria can include age, sex, medical history and current health status.
Eligibility criteria for cancer treatment trials often include the type and stage of cancer, as well as the type(s) of cancer treatment already received.

Enrolling people who have similar characteristics helps ensure that the outcome of a trial is due to the intervention being tested and not to other factors. In this way, eligibility criteria help researchers obtain the most accurate and meaningful results possible.

Quick Facts About Trial Eligibility, Costs and Payment

Every clinical trial has a protocol, or action plan that describes what will be done in the trial, how the trial will be conducted, and why each part of the trial is necessary. This protocol also includes guidelines for patient eligibility. These guidelines, called eligibility criteria, describe the characteristics and requirements all interested people must have before they can take part in the trial.
Eligibility criteria can include:

  • Age
  • Sex
  • Medical history, and
  • Current health status.

Eligibility criteria for cancer treatment trials often include the type, stage of cancer, and genetic make-up of the cancer.

Financial Requirements

Financial requirements to participate in a clinical trial vary depending on the type of trial. The costs of care for people participating in a clinical trial fall into two general categories:

  • Routine care costs, and
  • Research costs.

Routine care costs are costs associated with treating a person's cancer whether or not they are in a trial. These costs are usually covered by health insurance, but requirements vary by state and type of health plan.

Research costs are costs associated with conducting a clinical trial; these costs may include the costs of extra doctor visits, extra tests, and procedures that are required for the trial but would not be part of routine care.
Research costs are usually covered by the organization that sponsors the trial. For example, if the US government or a pharmaceutical company is sponsoring the trial, the costs will be covered by that organization.

Role of Private Insurance in Clinical Trial Costs

The total costs of participating in clinical trials are rarely covered for US residents by public or private insurance programs due the experimental nature of the treatments being tested. Coverage by foreign government programs for non-US residents is even less likely.

In order to participate in a clinical trial at Penn Medicine, patients will need to be able to pay for needed services not provided as part of the clinical trial directly or through your insurance company/health plan, if coverage can be secured. Patients will also need to be able to secure living arrangements, and pay for living expenses throughout the course of the trial if they do not live within the Philadelphia region.

Learn Your Financial Options

Penn Medicine has financial counselors to help with this process and review financial responsibilities with patients. To speak with a financial counselor, and learn your options, please contact 800-789-PENN (7366) or visit (send to web page).

Next FAQ: How is the safety of clinical trial participants protected? What is an IRB?