COVID-19: FDA, EMA and 16 drug manufacturers participate in development efforts

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Posted on April 17, 2020 | By Michael Mezher

COVID-19: FDA, EMA and 16 drug manufacturers participate in development efforts

On Friday, the National Institutes of Health (NIH) announced a new initiative to accelerate the development of coronavirus treatments and vaccines (COVID-19) involving the U.S. Food and Drug Administration (FDA) and others American health agencies, the European Medicines Agency. (EMA) and 16 drug manufacturers.

The goal of the Accelerating Therapeutic Interventions and Vaccines COVID-19 (ACTIV) partnership will be to develop a coordinated research strategy to prioritize candidate drugs and vaccines and to coordinate clinical trials and regulatory processes.

The announcement comes just days after a report The Washington Post described the search for treatments for the disease as “disorganized and dispersed” and revealed that the director of the NIH, Francis Collins, had been working for a month to rebuild the public-private partnership.

“We need to bring the full power of the biomedical research enterprise to this crisis,” said Collins in a statement announcing the initiative.

NIH says the partnership will be coordinated by the Non-Profit Foundation for the National Institutes of Health and will focus on four “accelerated” areas led by individual working groups.

Areas of intervention include standardization and sharing of preclinical assessment methods; prioritize and accelerate clinical evaluation; maximize the capacity and efficiency of clinical trials and advance vaccine development.

At the preclinical level, the effort calls for better access to high-throughput screening facilities in laboratories at biosafety level 3 to assess the compounds that have already been the subject of clinical trials with a view to potential application. COVID-19 and increased access to validated animal models.

For clinical trials, the partnership will create a steering committee “to set criteria and rank potential candidates submitted by industry partners for the first wave and subsequent evaluation” and calls for master protocols with agreed endpoints , sampling methods and analyzes to be used to assess potential treatments. NIH also says that only one control arm will be used in all participating studies. (RELATED: ICMRA traces data required for phase I studies on COVID-19 vaccine, Regulatory orientation March 24, 2020; Regulators Request RCTs With Control Arms For COVID-19 Drug Trials, Regulatory orientation April 9, 2020).

The initiative also calls for building on existing clinical trial networks and infrastructure and sharing information and ideas that could be useful for vaccine development.

NIH


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