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Clinical Trials

Clinical trials are research studies conducted with patients to find new and improved medical treatments for various diseases and life-threatening conditions. A Health Net member may participate in a clinical trial following a recommendation by the member's treating physician after the physician has determined that the clinical trial has the potential to benefit the member and Health Net has approved the participation.

Life-threatening condition is defined as any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted. Routine patient care costs refer to the costs associated with the provision of health care services, including medications, items, devices, and services that would otherwise be covered under the plan or contract if those medications, items, devices, and services were not provided in connection with an approved clinical trial program, including the following:

  • Health care services typically provided absent a clinical trial
  • Health care services required solely for the provision of the investigational medication, item, device, or service
  • Health care services required for the clinically appropriate monitoring of the investigational item or service
  • Health care services provided for the prevention of complications arising from the provision of the investigational medication, device or service
  • Health care services needed for reasonable and necessary care arising from the provision of the investigational medication, item, device or service, including the diagnosis or treatment of complications

Phase I, II, III, and IV clinical trials are approved when conducted for the prevention, detection or treatment of cancer or other life-threatening disease or condition, and are described in any of the following:

  • The treatment is part of a scientific study of a new therapy or intervention that is being conducted at an institution in California, that is for the treatment, palliation or prevention of cancer in humans and in which the scientific study includes all of the following:
    • Specific goals
    • A rationale and background for the study
    • Criteria for patient selection
    • Specific directions for administering the therapy and monitoring patients
    • A definition of quantitative measures for determining treatment response
    • Methods for documenting and treating adverse reactions
  • Treatment provided as part of a study being conducted in a phase I, II, III, or IV clinical trial
  • Proposed treatment or study reviewed and approved by an institutional review board of an institution in California. Institutional review board means any board, committee or other group that is both:
    • Formally designated by an institution to approve the initiation of and to conduct periodic review of biomedical research involving human subjects and in which the primary purpose of such review is to assure the protection of the rights and welfare of the human subjects and not to review a clinical trial for scientific merit
    • Approved by the National Institutes of Health Office for Protection from Research Risks
  • No clearly superior, noninvestigational treatment alternative exists
  • Available clinical or preclinical data provide a reasonable expectation that treatment will be at least as efficacious as any noninvestigational alternative  
Clinical Trial Phases
Phases Description
Phase I Determine toxicity through a continuum of modest dosing to determine safe levels for humans (classically considered the "first in human" studies)
Phase II Begin to evaluate the effectiveness of the treatment
Phase III Compare the new regimen to standard care to evaluate relative efficacy and therapeutic value
Phase IV Post-marketing studies to delineate additional information, including the medication's risk, benefits and optimal use

Clinical trials are research studies conducted with patients to find new and improved medical treatments for various diseases and conditions. A Health Net member may participate in a cancer clinical trial following a recommendation by the member's treating physician after the physician has determined that the cancer clinical trial has the potential to benefit the member and Health Net has approved the participation.

Last Updated: 04/29/2019