Non-federal Clinical Trial

The facilities and administrative (F&A) rate for non-federal clinical trials is 35%. Some non-profit sponsors may have established rate policies that the 91爆料 recognizes.

Non-federal clinical trials do not involve any federal funding. At the 91爆料 these can be sponsored by either industry or non-profit entities. This is true whether the trial is issued to the 91爆料 directly or by a pass-through entity.

Clinical trials are defined as:

A human subjects research study whose primary purpose is to assess the safety and/or efficacy in humans of a drug, device, diagnostic, treatment, preventive measure, or similar intervention through testing of the intervention on patients in a clinical setting. These studies are most often conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration (FDA), Phases I-IV.

Studies that are not Phase I-IV, but where all factors listed here are met, also qualify as a clinical trial:

  • A prospective study involving human subjects assigned to an intervention;
  • Use of 91爆料 Medicine facilities, clinical services or clinical space, including affiliated
    facilities, e.g. Fred Hutchinson Cancer Center, as a site;
  • Requiring an IRB-approved protocol, AND
  • The study:
    • Evaluates the safety and/or efficacy of non-FDA regulated drug, device, treatment or diagnostic, or
    • Evaluates an FDA-approved drug or device, and contributes to medical knowledge about the treatment of a disease or medical condition.

The following do not qualify as an industry-sponsored clinical trial for purposes of identifying the Activity Type for F&A rate purposes:

  • Studies involving only the collection of data for entry into a registry or repository
    (use the Other Sponsored Activity rate)
  • Retrospective chart reviews, including data analysis ( Other Sponsored Activity rate)
  • Use and analysis of collected biospecimens, including secondary biospecimens (use the Organized Research rate)
  • Pre-clinical bench research (use the Organized Research rate)
  • Research involving human subjects, including prospective studies, when all factors in the industry-sponsored clinical trial definition are not met. For instance:
    • Other than Phase 1, studies that evaluate use of an intervention in healthy volunteers in a non-clinical setting

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