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 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.