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

Rosemarie Barnabe, Cristina Torres, Grace Wangge, Edlyn Jimenez, Juntra Karbwang

Research output: Contribution to journalArticleOtherpeer-review


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.

Original languageEnglish
Pages (from-to)686-689
Number of pages4
JournalDrug Discovery Today
Issue number3
Publication statusPublished - Mar 2022
Externally publishedYes


  • COVID-19
  • Early access
  • Experimental therapies
  • LMICs
  • Regulatory oversight

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