Regulatory oversight on the use of experimental therapies during a pandemic: the case of early access to convalescent plasma therapy in three LMICs

Elsevier

Available online 11 December 2021

Drug Discovery TodayHighlights•

Plasma therapy continues to be an option against COVID-19 especially in LMICs.

LMICs need a regulatory pathway for early emergency access to experimental therapies.

This regulatory pathway should come with reporting and oversight measures.

The regulatory pathway must be completemented by public education.

Abstract

Clinicians, especially in low- and middle-income countries (LMICs), contend with limited economic and healthcare resources in deciding appropriate and feasible care for their patients. Some of the LMICs affected by COVID-19 implemented convalescent plasma therapy without sufficient regulatory guidance. Based on this experience, there are several requirements going forward, including: the need for an immediately accessible data gathering and processing system; the necessity of establishing regulatory pathways for early access to experimental treatment during emergency situations; and the accompanying reporting and monitoring requirements must be set. The different stakeholders must also be properly incorporated in the system that such a pathway will create, without neglecting to properly inform the public of the patient rights especially during an emergency situation.

Keywords

Early access

COVID-19

regulatory oversight

experimental therapies

LMICs

© 2021 The Author(s). Published by Elsevier Ltd.

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