ICMRA members pledge clinical, regulatory support for COVID-19 products
Members of the International Coalition of Medicines Regulatory Authorities (ICMRA) on Tuesday pledged to work together to speed the development and approval of medical products used in the fight against coronavirus disease (COVID-19).The statement follows several meetings organized by ICMRA aimed at developing a consensus among its members on data requirements for Phase 1 clinical trials for COVID-19 vaccines, developing therapeutics for the disease and using real-world evidence and observational studies to complement data from clinical trials.
“Our collaboration as regulators is crucial to increase the efficiency of regulatory processes and decision-making that will facilitate rapid development, approval and global roll-out of safe and efficacious medicines against COVID-19,” said European Medicines Agency Director and ICMRA Chair Guido Rasi.
As part of the pledge, ICMRA members say they will work together to align regulatory processes and requirements for products used for COVID-19, so they are “as efficient as possible.”
The group also commits to ensuring “equitable access to trials and medicines for the populations affected by COVID-19,” echoing a call made by the World Health Organization (WHO) last week when it announced its Access to COVID-19 Tools (ACT) accelerator. While the United States is not taking part in the WHO initiative, the US Food and Drug Administration (FDA) is an ICMRA member.
The statement emphasizes the “need for large, well-designed, controlled clinical trials that are capable of giving robust evidence of the safety and efficacy of proposed therapies for COVID-19,” stressing that, “It is essential and ethical that trials most likely to yield interpretable results are prioritised.” As STAT reports, some experts have criticized the lack of a control arm in an early US study of Gilead’s remdesivir in patients with severe cases of COVID-19, saying that the results of the study will be difficult to interpret as it compares patients receiving the drug for either five or 10 days.
ICMRA members also say that access to medicines and medical devices in low- and middle-income countries must be ensured. “Some of these countries are also at risk of greater disease burden, and a failure to address COVID-19 may results also in large remaining reservoirs of disease,” ICMRA writes.
ICMRA