President Trump last week promised in sweeping terms that the FDA will slash regulatory red tape to get COVID-19 therapeutics to patients as FDA Commissioner Stephen Hahn walked back some of Trump’s comments about what is realistic without jeopardizing patient safety.
Hahn said the agency is looking at any and all options, including off-label uses of approved drugs, even as he corrected some of the remarks Trump made in a White House Coronavirus Task Force briefing about how quickly the agency can get treatments to COVID-19 sufferers.
One off-label use candidate, chloroquine, is already approved for treating malaria, lupus and rheumatoid arthritis, Hahn said. The drug may reduce the duration of COVID-19 symptoms, as well as viral shedding, which can help prevent the spread of disease. Bayer announced yesterday that it is seeking an emergency use authorization for the drug.
Another candidate, Hahn said, is Gilead’s remdesivir, which is currently undergoing multiple clinical trials as a treatment for COVID-19.
Gilead offered remdesivir for treatment of a COVID-19 patient in Washington state and is supplying the drug for two trials in China for infected individuals with and without severe symptoms.
Trump said remdesivir is “very close to approval,” but Hahn did not give a precise timeline and he cautioned that offering a drug in the wrong dose could worsen the disease.
Last month, the National Institutes of Health (NIH) began a randomized controlled trial of remdesivir for treatment of COVID-19 patients. The FDA has been working with Gilead to find multiple pathways to study the drug under the agency’s investigational new drug requirements, as well as provide the drug to patients under the emergency use program.
The agency has so far granted about 250 patients access to the product through the emergency use authorization expanded access program, but says controlled clinical trials are needed to determine if the drug is safe and effective for treatment of COVID-19 infection.
Hahn cited the agency’s interest in evaluating therapies such as convalescent plasma and hyperimmune globulin products taken from blood donated by people who have recovered from the virus, that could shorten the length or lessen the severity of the COVID-19 illness.
“I have great hope for how we’re going to come out of this situation,” Hahn said. “What’s also important is not to provide false hope, but to provide hope.”
In response to the COVID-19 outbreak, the FDA is temporarily allowing devicemakers to expand the use of certain non-invasive patient monitoring devices so that trials can remotely keep tabs on patients’ vital signs.
The emergency guidance applies to certain clinical electronic thermometer, electrocardiograph (ECG), cardiac monitor, ECG software for over-the-counter use, pulse oximetry (spO2), non-invasive blood pressure, respiratory rate/breathing frequency and electronic stethoscope devices. The FDA said that the devices can connect to wireless networks to transmit patient measurements directly to trials, eliminating the need for face-to-face interaction.
The new policy, which will last as long as the public health emergency does, applies to certain changes to the devices’ indications, claims, functionality, hardware or software, that would make them suitable for remote monitoring.
“FDA does not intend to object to limited modifications … that are used to support patient monitoring during the declared public health emergency,” the guidance says.
Read the full guidance here: https://bit.ly/2UskYdd.
The FDA is suspending all inspections for the agency’s bioresearch monitoring (BIMO) program, except for those that are deemed “mission-critical.”
The agency will continue to evaluate data records in lieu of site inspections on an interim basis, FDA Commissioner Stephen Hahn said.
In addition, all eligible FDA employees are now teleworking. The telework order from Hahn does not apply to “non-portable” tasks, such as lab activities or the monitoring of imports, he said.
Pfizer is providing some of its trial sites with a virtual reality (VR) training tool that will give site staff a live 360-degree view of a room in which simulated procedures are conducted.
Pfizer plans to implement the training tool across several of its current sites, particularly those conducting phase 2 and 3 studies. All new investigative sites also will have access to the simulation tool. Currently, Pfizer expects VR training to be used for no more than 3 percent of the more than 200 trials the company conducts each year.
GeoMap Clinical is helping attract patients who are fearful of participating in trials during the COVID-19 outbreak with new artificial-intelligence (AI) powered tools that include online screening as well as encrypted digital contact to set up telephone calls with study coordinators.
Using the platform, which doesn’t require IRB or ethics committee approval, trials can begin recruiting participants in under 24 hours.
In an effort to reduce study site visits and potential exposure to and transmission of COVID-19, Medable has released a new TeleVisit mobile application that allows study participants to virtually connect with their clinical trial sites.
The app consents patients for the use of telemedicine, offers real-time video capabilities and gives participants instant virtual access to study coordinators and investigators. Medable’s TeleVisit app was designed for decentralized and hybrid trials and can be downloaded directly on participants’ mobile devices or tablets used by sites.
Medidata and Medpace are joining forces to create an imaging integration platform for clinical trials that will provide real-time data reconciliation, contain a single data repository, compute quantitative imaging biomarkers for trials across several different therapeutic areas, create an integrated workflow to determine eligibility of patients and monitor response and disease progression.