The EMA is calling for a comprehensive international coordination mechanism for adequately powered, randomized controlled trials that can generate sound evidence on the safety and efficacy of COVID-19 therapies and vaccines. “Although the scientific community has responded to the COVID-19 challenge in an unprecedented manner, there are concerns about the growing number of COVID-19 stand-alone clinical trials with a small number of participants and observational studies, which might not generate the data required for regulatory decision-making,” the EMA said. In an article published Friday in Clinical Pharmacology & Therapeutics, EMA authors outlined several actions aimed at improved coordination among researchers and the public and private sectors. For instance, they called for public and private consortia to ramp up their activities to take a wider role in managing clinical trials. They also asked patient organizations and professional societies to use their influence to encourage the coordination of trials and said ethics committees should ensure that the benefits of conducting a stand-alone COVID-19 trial outweighs the risks and burdens to the participants.
The European Commission said it has selected eight large-scale research projects for development of treatments and diagnostics for the SARS-CoV-2 virus. The program is supported by a fund of €117 million (US$126 million), €45 million of which will come from the biopharma industry. Five of the eight projects selected for funding are for diagnostics, with an emphasis on point-of-care tests that can deliver results in 15 or fewer minutes.
The FBI and the U.S. Cybersecurity and Infrastructure Security Agency (CISA) are warning COVID-19 researchers that they likely are being targeted and their networks compromised by China. “Healthcare, pharmaceutical and research sectors working on COVID-19 response should all be aware they are the prime targets of this activity and take the necessary steps to protect their systems,” the two agencies said in a joint statement Wednesday. Organizations that suspect suspicious activity should contact their local FBI field office. The agencies said they plan to release additional technical details about the threat in the coming days. Earlier this month, CISA and the U.K. National Cyber Security Agency released a similar alert warning of malicious actors targeting COVID-19 response organizations using a tactic of password spraying.
As the COVID-19 pandemic continues, the FDA is racing to produce new and updated guidance to accelerate the development of coronavirus therapies while responding to the challenges the pandemic is creating for ongoing drug development. This week, the agency updated its guidance on conducting clinical trials during the COVID-19 emergency by adding content to the question-and-answer appendix. The additions discuss considerations for using alternate laboratories or imaging centers, holding trial participant visits via videoconference and conducting required postmarketing trials. The agency also updated the information about managing protocol deviations and amendments to ongoing trials, and about consulting with the FDA on administering investigational drug infusions at home rather than at the trial site.
The FDA also released two new COVID-19 guidances this week. The first guidance discusses general considerations for pre-investigational new drug application meeting requests and outlines a more efficient process for sponsors to receive agency feedback on their supporting data so they can begin clinical trials as soon as possible. In the second guidance, “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention,” the FDA advises on later-stage trials intended to establish the safety and effectiveness for COVID-19 products. The guidance discusses considerations such as appropriate patient selection and trial design.
The White House appointed former Glaxosmithkline plc vaccines chief Moncef Slaoui as chief advisor of Operation Warp Speed, the Trump administration's new national program to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics. One of the efforts is "to have substantial quantities of a safe and effective vaccine available for Americans by January 2021." In addition to Slaoui, and General Gustave Perna, who will act as chief operating officer for the effort, FDA leaders Peter Marks and Janet Woodcock along with Bruce Tromberg, director of the NIH's National Institute of Biomedical Imaging and Bioengineering, will work on the project. As a condition of receiving support from Operation Warp Speed, companies will provide a donated allocation of countermeasures developed, including an eventual vaccine, the administration said. "The federal government is making investments in manufacturing and distribution at its own risk much earlier than usual, giving firms confidence that they can invest aggressively in development of countermeasures," the government said in a statement about the effort.
The U.K.’s National Institute for Health and Care Excellence published two new rapid COVID-19 guidelines on dealing with chronic kidney disease (CKD) and interstitial lung disease. Patients with CKD who may have COVID-19 should continue taking their medicines unless advised otherwise by their doctor. The CKD guideline recommends that patients who are stable on their treatment should be assessed to determine if it’s safe to reduce the frequency of their routine kidney function tests. The guideline for patients with interstitial lung disease advises on adjusting care to reducing a patient’s exposure to COVID-19 and balancing the risks and benefits of using drugs that affect the immune response during the pandemic.
Qing Wang, a former Cleveland Clinic Foundation employee, was arrested last week and charged with false claims and wire fraud in connection with $3.6 million in NIH funding he and his research office received. According to the U.S. Department of Justice (DoJ), Wang knowingly failed to disclose to the NIH his affiliation with the Huazhong University of Science and Technology in Wuhan, China, where he served as dean of the College of Life Sciences and Technology and received research grants that overlapped with the focus of his NIH grants. He also allegedly took part in China’s Thousand Talents Program (TTP), which recruits individuals who have knowledge of or access to technology or intellectual property developed outside China. Wang reportedly received $3 million in research support, along with free travel and lodging, for his TTP participation, but none of that was disclosed to the NIH, DoJ said.