Lurie Children's Hospital of Chicago | Pediatric Medicine



An investigational drug may be used in an emergency for a single patient if the following are met:The patient is in a life-threatening situation or there is a threat of severe debilitationThere is insufficient time for IRB approval at convened meetingThe treatment is judged to be potentially beneficial & the risk not greater than disease/conditionThere is no standard acceptable treatment or IRB-approved protocol available to patient1) Prepare a de-identified summary that includes the following:Patient’s disease course & previous treatments Justification of emergency (how it meets the criteria above)Plan for administration of the drug/devicePlan for safety monitoring2) Contact the sponsor/manufacture to obtain their agreement to provide the drug. Obtain a letter of authorization (LOA) from the sponsor granting a right to reference the information contained in their existing IND.3) Obtain an emergency IND (eIND) from the FDA. Either the treating physician or sponsor may do this. If it is non-urgent, submit a Form FDA 3926 to request single patient expanded access IND (which requires full IRB review). If it is urgent, call the FDA to obtain an eIND number via phone. Then submit an FDA IND application to the appropriate review division in the Center for Drug Evaluation and Research (CDER) within 15 days of administration (Step 8 below).4) Prepare a consent form without references to “research” Non-research Consent Templates are available in the Research Toolkit on the website.An exception from informed consent may be made under certain circumstances, see FDA Guidance for details.5) Obtain IRB chair acknowledgement prior to administration if time permits. Submit initial application for Emergency Use via Cayuse IRB. Also contact the IRB office via e-mail or phone to alert them to the submission. Include:De-identified summary of patient and plan of administrationConsent form or written justification for exemption of obtaining consentFDA eIND approval letter or FDA concurrence of use of deviceSponsor acknowledgementLetter of support for the Investigational Drug Service 6) Obtain consent from the patient/LAR before administering the investigational drug7) Submit a report to the IRB within 5 working days of administration and include:Summary of the outcome of administration and patient statusIf informed consent was not obtained, submit an independent physician’s determination that conditions for exception were met.If the patient is to continue receiving the test article, submit summary of plan for continued administration and monitoring.8) By Day 15, submit the expanded access IND application to the appropriate Review Division in the Center for Drug Evaluation and Research (CDER) at the FDAUse Form FDA 3926 and provide LOA from sponsor/manufacturerReference the eIND provided to you by the FDA staff via phone (Step 3 above)See next page for links to FDA ResourcesDirect Links to FDA Resources: diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.Severely debilitating?means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke. ................
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