The National Institutes of Health announced an initiative Friday to unify disparate efforts across the drug industry to respond to the coronavirus-related pandemic.
Pharmaceutical companies will collaborate across hundreds of COVID-19 clinical trials, the NIH says, by sharing “master protocols” on how those clinical trials will work.
“Collaboration is a critical ingredient for success and the FDA will continue to use every tool possible under our Coronavirus Treatment Acceleration Program to speed the development of safe and effective medical countermeasures,” said Food and Drug Administration Commissioner Stephen Hahn in a statement.
The coronavirus-related research race has been thus far marked by chaos as dozens of private companies and researchers compete for a cure, according to a recent news report.
Project collaborators include 16 pharmaceutical companies and several government agencies. The Foundation for the National Institutes of Health, an affiliated nonprofit, is coordinating the effort. The project also loops in the European Medicines Agency, an agency of the European Union responsible for the scientific evaluation of medicines.
The project will streamline COVID-19 research by sharing clinical trial designs with agreed-upon endpoints, sampling and analysis for evaluating candidates, the NIH says. The project also calls for using a single control arm across trials.
This sort of effort is not entirely unprecedented, according to Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development.
“For a number of years, the FDA and NIH have been advancing Basket, Umbrella, and Platform trials using a Master Protocol,” Kaitin wrote in an email. “The platform trial design uses a single control group across multiple trials.”
A basket trial tests one medicine for multiple diseases, while an umbrella trial tests multiple therapies for one or more diseases.
“All these designs are meant to enhance efficiency by reducing the number of patients that need to be enrolled and simplifying the overall trial design,” he wrote.
One drawback of having one control group is that it could lead to results that don’t accurately reflect people across different demographics, or people in more moderate or severe stages of the disease.
“That’s something that needs to be considered when using a platform design,” Kaitin said.
Some researchers have been calling for greater global collaboration on medical research on the novel coronavirus that causes COVID-19, known as SARS-CoV-2, in recent weeks.
“Taking this big, coordinated approach to developing a SARS-CoV-2 vaccine will not only potentially save hundreds of thousands of lives, but will also help the world be better prepared for the next pandemic,” wrote Seth Berkley, CEO of Gavi, the Vaccine Alliance, an organization that supports global immunization efforts, in a recent Science magazine article.
There is precedent for collaboration, he argued, pointing to the Human Genome Project and CERN, a joint European scientific venture related to particle physics.
Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases and a member of the White House’s coronavirus task force, has likened the new effort to a “national strategy.”
It’s the latest federal project in response to the pandemic to be likened to wartime initiatives. Sen. Charles E. Schumer, D-N.Y., has likened billions of dollars Congress has approved for hospitals hemorrhaging funding because of the pandemic to the post-World War II “Marshall Plan” of U.S. aid to Europe.
It’s unclear whether government efforts to streamline research will give regulators greater leverage to own the medicines that result, or cap their prices.
“Words missing from the NIH announcement…Price. Affordability. Patent. Intellectual Property,” tweeted James Love, director of Knowledge Ecology International, a nonprofit that calls for greater government ownership of publicly funded pharmaceutical research.
“This partnership is somewhat encouraging as it will allow information and research methods to be shared more easily, but NIH is being far too shy about using its federal power during a pandemic,” wrote Peter Maybarduk, a director with consumer rights group Public Citizen, in a letter to the NIH.
The Foundation for the National Institutes of Health does not publish an online list of its corporate donations, which in the past has raised questions about potential conflicts of interest. The foundation has been dogged in recent years by ethical questions about its collaborations with National Football League on concussions research and beer and liquor conglomerates on alcohol research.
The project will establish a steering committee to “set criteria for and rank potential candidates [for vaccines and therapies] submitted by industry partners,” the NIH says. The agency has not yet said who will serve on the committee.
Federal officials are calling the initiative the “Accelerating COVID-19 Therapeutic Interventions and Vaccines” plan, or ACTIV.
Partner government agencies include the FDA, Health and Human Services Office of the Assistant Secretary for Preparedness and Response, and the Centers for Disease Control and Prevention.
The 16 companies listed as partners in the project include AbbVie; Amgen; AstraZeneca; Bristol Myers Squibb; Evotec; GlaxoSmithKline; Johnson & Johnson; KSQ Therapeutics; Eli Lilly and Company; Merck & Co.; Novartis; Pfizer; Roche; Sanofi; Takeda; and Vir Biotechnology.