Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs.
Drug Discov Today
; 27(3): 686-689, 2022 03.
Article
in English
| MEDLINE | ID: covidwho-1562140
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pandemics
/
COVID-19
Type of study:
Observational study
Limits:
Humans
Language:
English
Journal:
Drug Discov Today
Journal subject:
Pharmacology
/
Drug Therapy
Year:
2022
Document Type:
Article
Similar
MEDLINE
...
LILACS
LIS