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Right to Try

INFORMATION ABOUT RIGHT TO TRY:

California’s Right to Try law gives terminally ill patients access to drugs that have not been fully approved by the U.S. Food and Drug Administration. This law offers patients who have been diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who are unable to participate in a clinical trial, access certain unapproved treatments.

An eligible patient is a patient who has:

  • Been diagnosed with a life-threatening disease or condition
  • Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
  • Provided (or their legally authorized representative has provided) written informed consent regarding the eligible investigational drug to the treating physician

An eligible investigational drug is an investigational drug:

  • For which a Phase 1 clinical trial has been completed
  • That has not been approved or licensed by the FDA for any use
  • For which an application has been filed with the FDA, or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval, and is the subject of an active investigational new drug application submitted to the FDA
  • Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA

UNIVERSITY OF SOUTHERN CALIFORNIA

TREATMENT WITH AN INVESTIGATIONAL DRUG OR BIOLOGIC UNDER RIGHT TO TRY ACT

TREATING PHYSICIAN CHECKLIST

  1. CONFIRM DRUG APPLICABILITY CRITERIA:
    • The investigational drug or biologic has successfully completed a Phase I clinical trial. NOTE: Use of an unapproved device not allowed under RTT.  Use expanded access process.
    • The drug or biologic is under investigation in a clinical trial.
    • The drug or biologic is actively being developed/produced by the manufacturer OR not placed on clinical hold.
    • Written concurrence has been obtained from an uninvolved physician with the use of the test article.
  2. CONFIRM THAT THE PATIENT MEETS THE FOLLOWING CRITERIA:
    • The patient has an immediately life-threatening disease or condition (a stage of disease in which there is a reasonable likelihood that death will occur in a matter of months).
    • The patient has exhausted all other approved treatment options.
    • The patient is unable to participate in a clinical trial of the product.
  3. SEEK IRB APPROVAL OF CONSENT AND DOCUMENT.  GATHER THE FOLLOWING DOCUMENTS:
    • Treatment Plan, include the cost of treatment
    • Draft a Right to Try Consent Form based on template provided by USC IRB
    • Review and sign Treating Physician Attestation
    • Submit Documentation to the IRB through the IRB Application process
  4. OTHER TREATING PHYSICIAN RESPONSIBILITIES:
    • Consult with USC Clinical Trials Office (CTO) to determine billing implications.
    • Consult with Investigational Drug Services pharmacy to determine drug requirements.
    • Ensure patient understands financial and health care considerations outlined in consent form.
    • Register the patient in OnCore, as determined by CTO.