A new $4.9 million contract awarded by the US Food and Drug Administration (FDA) seeks to improve how the agency deploys medical countermeasures during public health crises like Ebola.
"In emergency situations, rapid response is critical," FDA writes on its website. And while that response often includes basic provisions—money to buy supplies and the deployment of healthcare providers to an area, for example—it almost always includes medical products like drugs and medical devices as well.
But therein lies a problem: The products deployed during emergencies aren't always as well-tested as products used during more typical situations. For example, patients might be subject to products approved under FDA's "Animal Rule," which approves products based on safety testing in humans and efficacy testing in animals, or investigational products not yet proven to be safe or effective in humans.
And FDA has a key question regarding these products: Do they work as intended?
Until now, it's been difficult to say. The focus of public health officials during emergencies is on stopping the emergency—not setting up new clinical trials and trial sites to test products.
FDA's new four-year contract with the US Critical Illness and Injury Trials Group (USCIITG) is intended to change that, albeit on a small scale. The contract will go toward helping to "speed access to and evaluation of medical countermeasures during public health emergencies," FDA said.
"USCIITG will work to pre-position Phase 4 [post-market evaluation] studies in advance of a public health emergency. This includes obtaining full IRB approval before an event happens, to allow for the collection of data during an emergency," FDA explained.
A Centralized IRB
One of the main goals of the contract will be to set up a "Central Institutional Review Board … to review trial protocols for many institutions simultaneously." This would help physicians to administer products under approved protocols and allow them to quickly find out which products work and which do not.
A similar system might be useful in determining which treatments for Ebola work best in patients, for example.
Initial Focus on the Flu
One of the contract's main foci will be on developing a treatment protocol for intravenous zanamivir, "an investigational antiviral influenza treatment" which is now only available in clinical trials or through emergency investigational new drug (IND) requests. "This project will allow the use of IV zanamivir in hospitalized adult and pediatric patients with severe influenza during the 2015-2016 flu season and allow FDA to collect valuable standardized information on the clinical use of this investigational drug, with data consistently collected across multiple sites," the agency said.
The project will rely on pre-positioning investigational treatments at 20 hospitals around the country and the creation of an electronic care report form (eCRF) meant to expedite data reporting.
The project will ultimately help doctors obtain treatments for patients more easily and help the agency to collect better data on treatments, FDA hypothesized.