Regulatory Open Forum

Does anyone have any references for cross border trail participation in the US/Mexico/Canada? I became aware of trial participants that are seen in the USA and cross back to their home in either Mexico or Canada with investigational product and return for study visits and re-supply. From the GCP side of things, Can someone point me to any references that would or would not allow this?

Thanks

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Martin Caron
bluebird bio, inc.
Provincetown MA
United States
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I do not see a GCP issue with the practice. I have managed a clinical trial where patients were seen for their routine care in one country and traveled to another country for infusions of the investigational product. It is not unusual at all for US patients to go to Canada for less expensive drugs and bring them home. It is not illegal to transport personal quantities of approved product and I am not aware of any regulations for investigational products. 

There is a history of a requirement or preference for local ethics review that would reflect the values of the community in which the trial is being conducted. With the emphasis now on central ethics review for global multicenter trials that idea no longer seems as relevant. 

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Glen Park PharmD
Consultant
Burien WA
United States
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Original Message:
Sent: 23-Jan-2024 14:15
From: Martin Caron
Subject: Cross Border Trial Participants US/Mexico/Canada

Does anyone have any references for cross border trail participation in the US/Mexico/Canada? I became aware of trial participants that are seen in the USA and cross back to their home in either Mexico or Canada with investigational product and return for study visits and re-supply. From the GCP side of things, Can someone point me to any references that would or would not allow this?

Thanks

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Martin Caron
bluebird bio, inc.
Provincetown MA
United States
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Per FDA regulations, the international participants may be enrolled in the clinical trials if they meet specific clinical eligibility criteria listed in the protocol.

From GCP viewpoint, the following factors may be considered prior to resorting to international patient recruitment:

(1)   Language: Adjustments may need to be made to the ICF wording (with appropriate customization, review, and approval process) as well as to any other patient facing documents.

(2)   Travel expense: Reimbursement details in relation to air-fare, ground transportation, and subsistence must be stated in the ICF

(3)   Underlying patient's condition: Combination of international travel, climate and dietary changes could impact patient's disease.

(4)   Local IRB/Ethics Committee may need to review the international patient enrollment in case patients are reimbursed significant amount of money to check for potential coercion and undue incentive to join the study.

 

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Shilpa Pathak
IQVIA Biotech
Powell OH
United States
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Original Message:
Sent: 23-Jan-2024 14:15
From: Martin Caron
Subject: Cross Border Trial Participants US/Mexico/Canada

Does anyone have any references for cross border trail participation in the US/Mexico/Canada? I became aware of trial participants that are seen in the USA and cross back to their home in either Mexico or Canada with investigational product and return for study visits and re-supply. From the GCP side of things, Can someone point me to any references that would or would not allow this?

Thanks

------------------------------
Martin Caron
bluebird bio, inc.
Provincetown MA
United States
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