COVID-19: FDA, EMA and 16 drugmakers take part in development effort

Regulatory NewsRegulatory News | 17 April 2020 |  By 

The National Institutes of Health (NIH) on Friday announced a new initiative to accelerate the development of treatments and vaccines for coronavirus disease (COVID-19) involving the US Food and Drug Administration (FDA) and other US health agencies, the European Medicines Agency (EMA) and 16 drugmakers.
The goal of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will be to develop a coordinated research strategy to prioritize drug and vaccine candidates and coordinate clinical trials and regulatory processes.
The announcement comes just days after a report in The Washington Post called the search for treatments for the disease “disorganized and scattershot” and revealed that NIH Director Francis Collins had been working for the past month to piece together the public-private partnership.
“We need to bring the full power of the biomedical research enterprise to bear on this crisis,” Collins said in a statement announcing the initiative.
NIH says the partnership will be coordinated by the nonprofit Foundation for the National Institutes of Health and will focus on four “fast-track” areas led by individual working groups.
The focus areas include standardizing and sharing preclinical evaluation methods; prioritizing and accelerating clinical evaluation; maximizing clinical trial capacity and effectiveness and advancing vaccine development.
On the preclinical end, the effort calls for greater access to high-throughput screening facilities at biosafety level-3 laboratories to assess compounds that have already been in clinical trials for potential application to COVID-19 and increasing access to validated animal models.
For clinical testing, the partnership will create a steering committee “to set criteria for and rank potential candidates submitted by industry partners for first wave and subsequent evaluation” and calls for master protocols with agreed upon endpoints, sampling methods and analyses to be used to evaluate potential treatments. NIH also says that a single control arm will be used across participating studies. (RELATED: ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies, Regulatory Focus 24 March 2020; Regulators urge RCTs with control arms for COVID-19 drug trials, Regulatory Focus 9 April 2020).
The initiative also calls for leveraging existing clinical trial networks and infrastructure and pooling of information and insights that could be useful to vaccine development.


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