University of California, San Diego

Official Statements

Score contribution: 100 — 3 supporting sources.

Score 1003 references

Featured Reference

UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH ...Opens in new window

“FDA guidance includes the following: “When a patient has a serious or life-threatening condition that is not addressed by current approved treatments, options may exist to use an investigational medical device (i.e., one that has not been approved or cleared by FDA) to treat the patient...there are circumstances under which a health care provider may use an investigational device outside of a clinical study to save the life of a patient or to help a patient suffering from a serious disease or condition for which no other alternative therapy exists. The use of an investigational device outside of a clinical trial for treatment of a patient is called ‘expanded access.’ If enrollment in an existing clinical trial protocol is not possible (e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials to address the patient’s condition), patients/physicians have the potential to receive expanded access to investigational devices under one of three alternative mechanisms.””

UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH ...Source

“If a UCSD treating physician submits the request to open an expanded access IND application and receives FDA’s authorization to use the investigational product, the UCSD treating physician is considered the sponsor and has the same responsibilities of a sponsor as for an IND application for clinical investigations (see above).”

Phage Therapy FAQSource

“Phage therapy is not currently a licensed treatment in the United States. However, patients with serious multidrug-resistant or device-related bacterial infections that are not responding to antibiotics may be eligible for phage therapy through a special request from the Food and Drug Administration’s Emergency or Singe Patient Expanded Access Investigational New Drug (IND) procedure. If you meet specific criteria and are being treated at UC San Diego Health, our medical team can make this request to the FDA. If you are receiving care elsewhere, we can provide your doctor with advice about how to make this request.”

EAP Related Articles from Sponsor

Score contribution: 80 — 4 supporting sources.

Score 804 references

Featured Reference

Submit a ContractOpens in new window

Emergency Use or Compassionate Use agreements are to be submitted using the form link below. Select "Emergency Use/Compassionate Use" to initiate your request. Please Note: This form is intended for unfunded Emergency Use/Compassionate Use contract review requests to facilitate a UCSD PI obtaining expanded access to an investigational drug or device for the purpose of diagnosing, monitoring, or treating a UCSD patient's disease or condition rather than to conduct research and obtain information and data that is generally derived from a clinical trial.

Forms & InstructionsSource

- **Expanded Access Consent Form** template\| [MS Word](https://irb.ucsd.edu/researchers/Expanded-Access-Consent-Form-v-2019-03-22.docx)

Who We AreSource

We have treated and will continue to treat patients with life-threatening multi-drug resistant infections with phage therapy through the FDA's compassionate use program.

Clinical Trials with rDNA: Instructions for Submission to the IBCSource

The deliberate transfer of recombinant or synthetic nucleic acids into one human research participant, conducted under a Food and Drug Administration (FDA) regulated individual patient expanded access Investigational New Drug (eIND) or protocol, including for emergency use, is not research subject to the NIH Guidelines. However, expanded use may pose a hazard to health care workers and community members. These trials will need to be submitted to the IBC for review and approval. The HGT IBC and Campus IBC are set-up to accommodate expedited reviews for expanded access. Contact ehsbio@ucsd.edu for questions regarding IBC oversight of expanded access or to request an expedited review.

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 1 supporting sources.

Score 401 references

Featured Reference

Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated CholestasisOpens in new window

Conditions: Cholestasis

Expanded Access Intelligence

Official Statements

Past EAPs on ClinicalTrials.gov

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