Emergency clinical research: Biden's OSTP wants to settle 'key terms' in advance of trials

26 Oct 2022
endpts.com
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Looking back at the pandemic so far, it’s easy to spot the holes in the US clinical trial research infrastructure.
But there have been models for coordinated trials too, like the UK-based RECOVERY trial that’s enrolled more than 48,000 participants across various studies. Early on, in June 2020, RECOVERY helped to uncover the fact that an inexpensive steroid pill, dexamethasone, significantly reduced deaths.
In the US, the story was different.
As Janet Woodcock, principal deputy commissioner said at a Milken Institute event in 2021:
There was a tremendous amount of duplication, and a lot of small trials that yielded tantalizing information that sent people off to use treatments that were not useful and potentially harmful…In a global emergency we need to have more central coordination because we should really randomize the first patient.
On the lack of research infrastructure, Woodcock explained how communities without academic medical centers or trained personnel were stuck without any options for trials.
“You can’t just build up infrastructure capacity in the middle of a pandemic,” she said. “We had tens of thousands of people dying from Covid, and we couldn’t get enough patients enrolled in some trials.”
The White House’s Office of Science and Technology Policy (OSTP), with a newly sworn in director, Arati Prabhakar, in partnership with the National Security Council on Tuesday announced plans to ensure that coordinated and large-scale clinical trials “can be efficiently carried out across a range of institutions and sites to address outbreaks of disease and other emergencies.”
In addition to learning how best to write up new, more standardized emergency clinical trial protocols ahead of the next outbreak, they also want to identify institutions and networks that have an interest in participating in these emergency studies, and “how to create or enhance incentives” for participation.
The Biden admin explains that it’s ready to develop a US-level governance structure and conduct outreach to a wide range of institutions, clinical trial networks and other potential trial sites that can participate in emergency research, both domestically and internationally.
“A further goal of this emergency clinical trial’s initiative is to support the expansion of clinical research into underserved communities, and increase diversity among both trial participants and clinical trial investigators,” OSTP says in today’s Federal Register. “Building U.S. capacity to carry out emergency clinical trials will enlarge and strengthen the U.S. clinical trials infrastructure overall.”
OSTP says it’s looking for comment on how to ensure that trial sites in underserved areas are included, and how to increase diversity both among study participants and among the investigators who lead trials to completion.
“We would appreciate receiving comments on how the domestic emergency clinical trials effort overall can be designed to coordinate with international research and preparedness initiatives,” the notice says.
While noting that in recent emergency settings, “we have seen that the launch of clinical trials across separate institutions or networks can be delayed by the process of coming to agreement on certain key issues, such as data sharing and the publication of results,” OSTP seeks comment on what a new national framework might look like and how might it be deployed in advance of an emergency.
So-called “Emergency Master Agreements,” the White House office notes, could shorten the time it takes to start emergency trials across a range of sites and ensure that certain basic terms could be relevant for any coordinated or large-scale emergency clinical trial, such as to “allow data gathered under common protocols from a range of sites to be collected and made readily accessible to researchers beyond the institutions where the trial was conducted.”
Other basic terms might include how to centrally manage biospecimens or use a single IRB, OSTP notes, adding that an Emergency Master Agreement could include additional terms that might only be needed for certain types of study protocols, such as if an investigational drug is being tested.
“One potential model would be to collect data from emergency clinical trials in a centralized data repository or small set of repositories, with a central biorepository for biospecimens collected during trials,” the RFI says.
It also discusses the term “Warm base,” which refers to studies that gather data under a research protocol, but also serve as sites ready to undertake additional or future research.
“Warm base” studies could address infectious diseases such as influenza or other medical conditions that are of interest to researchers and communities, such as cancer and heart disease, OSTP says.
The office seeks comment “on a variety of issues related to ‘warm base’ research, including disease areas that might be targeted and how ‘warm base’ research can be implemented to provide targeted training for trial sites, as appropriate to staff roles,” the RFI adds.
From a technical perspective, OSTP is also seeking input on how best to operationalize both protocol distribution and data capture in a forthcoming RFI, and it seeks more info on the criteria that should be applied to determine when emergency clinical research may be needed, and how that determination might be communicated to institutions and clinical trial networks that can participate in carrying out the research.
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