Instructions to be followed for treating a patient with an investigational agent at an non-study location

This guideline outlines the steps to be taken and considerations if a study subject is to receive an intervention at a non-study site, due to restrictions from the current COVID 19 outbreak. 

This applies to subjects already enrolled on an NIH IRP protocol. New patients should not be enrolled nor initiate study interventions at a non-study location. This is intended only as a temporary mechanism for the short-term continuation of a study drug that must be administered by health care provider (e.g. IV administration) and that is essential for the welfare of a subject. This is not for drugs that may be taken orally or that subjects routinely self-administer at home.

Subjects must be transitioned back to an NIH study site as soon as feasible.

• Is there an effective alternative approved regimen to which the subject can be transitioned?
  • If yes, is there a compelling justification for the subject to remain on study
    • If there is not a compelling justification, the subject should be transitioned to the alternative regimen and come off study.
• Is it in the best interest of the subject to remain on the study drug?
  
  • If no, the patient should be removed from the study and transitioned to standard clinical care.
• Has sponsor approval of your proposed plan been obtained (mandatory for all IND or non-IND sponsored studies)
  • If there is no sponsor, this is n/a
  • If sponsored, documentation from the sponsor must be provided.
• Are there pharmaceutical collaborators (i.e. CRADA partner)?
  • If yes, the CRADA or other agreement may limit redistribution of the drug. Agreement of the collaborator must be obtained if needed.
• Has a location and responsible physician been identified that has the necessary capabilities and is willing to administer the study drug and perform all required safety monitoring?
  • If yes, written documentation must be provided.
    • An email communication originating from the responsible physician is sufficient.
• Will the sponsor ship the drug directly to the non-study location?
  • This is the highly preferred approach.
• If the sponsor will not ship, has the CC investigational pharmacy agreed to ship the drug to the non-study location?
  
  • Contact Pharmacy (Esther Jeon) to arrange for shipping. Before proceeding you must have assurance from Pharmacy that they are able and willing to ship.
• Notify the IRB via iRIS using the “single patient planned deviation request form” to the protocol for each patient.

Responsibilities of the NIH PI are as follows:

• Provide oversight of the activities of the non-study physician. This includes, but is not limited to:
  • Review of all lab data for safety purposes
  • Respond to all queries from non-study site
  • Communicate any new information to the non-study physician
• Provide any protocol specific training (e.g. how to report adverse events) needed to the non-study physician and staff
• Provide a copy of the protocol and any other information necessary to the non-study physician and staff that is necessary for the safety of the subject.
• Provide a copy of the signed ICF to the non-study physician
• Keep the sponsor informed and up to date
• Continue with all required reporting (e.g. IC, sponsor and IRB). Sponsor remains responsible for FDA reporting

Responsibilities of the non-study physician:

• Administer the study intervention as directed by the PI
• Perform any monitoring as directed by the PI
• Communicate any information and results to the PI in a timely fashion and in accordance with the protocol

What interventions/procedures can be done at the non-study site?

• Only administration of the investigational agent and any needed SOC drugs or monitoring required for the safety of the subject can be performed at the non-study sites. For example, it is permissible to check needed SOC safety labs or perform clinical scans/imaging to assess safety and/or response to therapy.
• No procedures that are not required for the safety and welfare of the subject may be performed. For example, a biopsy for research purposes would not be permissible.

What if no outside location or physician can be located?

• Appeal to Clinical Center for an exception to allow the subject to come to Clinical Center.
• If exception is not granted, contact sponsor for assistance.
• Remove subject from study and transition to clinical care.

What if subject is located overseas?

• If possible, the subject should be transitioned to clinical care, if effective alternative therapies are available.
• All steps outlined at the top of this document still must be followed, as if this was a US site.
• All international laws and regulation must be met if considering shipping drug internationally. This may require in-country FDA (or the like) approval.
• If you plan to ship drug internationally, contact Lisa Goldfeder at ORSC.