The first attempt at using existing drugs to treat patients infected with SARS-CoV-2 has yielded disappointing results. In 200 hospitalized patients with severe COVID-19, a 14-day regimen of twice-daily treatment with Kaletra/Aluvia (lopinavir/ritonavir, Abbvie Inc.) did not hasten recovery when added to the standard of care.
With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic.
Multiple tactics employed by the biopharma industry to improve the recruitment and retention of participants in clinical trials seem to be paying off. More than three of four (77%) studies now fully enroll on or ahead of schedule, according to researchers at the Tufts Center for the Study of Drug Development (CSDD), reporting in the January/February Tufts CSDD Impact Report on global recruitment performance benchmarks.
A new study of 30 patients has demonstrated that embolization coils adequately seal the left atrial appendage after implant of LAA closure devices, but the author of an accompanying editorial expressed concerns regarding the absence of understanding of both the causes and implications of these leaks.
LONDON – A high level U.K. group, involving industry, academia, patients, health technology assessment and regulatory representatives, has set out guidelines for designing complex cancer trials and is calling for their rapid implementation to reduce clinical development timelines.
Check-Cap Ltd., of Isfiya, Israel, reported positive results from a U.S. pilot study of its C-Scan System, a preparation-free, ingestible scanning capsule-based technology aimed at preventing colorectal cancer (CRC) through early detection of precancerous polyps. The company is currently preparing an IDE submission with the U.S. FDA and plans to launch a pivotal clinical trial in late 2020.
PARIS – A team of medical researchers and engineers from the Gustave Roussy Institute, in Villejuif, France, and Paris-Sud University recently developed an artificial intelligence system called Resolved2, designed to assess prospective cancer drugs. As Loïc Verlingue, lead cancer specialist on the data science team at the Gustave Roussy Institute, explained to BioWorld MedTech, “this AI is intended to predict efficiently whether a cancer treatment molecule will achieve authorization or not within six years of pharmacological data and phase I clinical trials.”
PERTH, Australia – Despite a Senate inquiry recommendation to hold off on introducing cuts to Australia’s Research and Development Tax Incentive (RDTI), a bill that recommends cuts was introduced in Parliament, sending shudders through the biotech industry. “Ausbiotech is deeply concerned that the RDTI Bill has been reintroduced, despite the Senate Committee’s recommendations to defer consideration of the bill until further examination and analysis of the impact is undertaken,” said Ausbiotech CEO Lorraine Chiroiu.
PERTH, Australia – Despite a Senate inquiry recommendation to hold off on introducing cuts to Australia’s Research and Development Tax Incentive (RDTI), a bill that recommends cuts was introduced in Parliament, sending shudders through the biotech industry.
ORLANDO, Fla. – In an effort to get sickle cell disease (SCD) researchers, drug developers, patients and regulators all on the same page, the American Society of Hematology (ASH) and the FDA have released new recommendations aimed at establishing uniform global standards for clinical trial endpoints to evaluate new therapies.
