Sponsors of cancer drugs seeking FDA’s accelerated approval (AA) should use trial designs that show clinical benefit in an early stage rather than following the traditional three-phase model and waiting to initiate a confirmatory trial after AA is granted, recommend several FDA Oncology Center of Excellence (OCE) officials. Read More
If Robert Califf’s nomination to helm the FDA a second time succeeds in Congress, he is likely to push for clinical research reforms, with a focus on diversity, the increased use of real-world evidence (RWE) and addressing the rising costs and complexity of trials. Read More
Advances in technology and data management, as well as increasing support from regulators, are fueling the use of wearables in clinical trials, along with sponsors’ increasing realization that the data they collect from patients’ daily lives is often better than what they can collect at sites. Read More
Trials of COVID-19 vaccines, along with research into variants of the SARS-CoV-2 virus that causes the disease, will dominate the vaccine development space through 2022, with some nonCOVID vaccine trials slowly trickling back after being delayed by the pandemic. Read More
As the clinical trials industry looks back on what has been an incredibly disruptive year, questions are being raised about what to expect in 2021. One thing is certain: a return to normalcy is not in the cards although there is cause for hope about how COVID-19 has altered the clinical trials landscape. Read More
Independent sites without the time, staff or accounting experience to keep a close eye on sponsor billing and payments can avoid losing thousands of dollars by instituting a few best practices to help keep the cash flowing. Read More
COVID-19 should come as a prompt to the clinical research sector to rapidly reinvent itself as it works to design and launch clinical trials for vaccine and therapeutic candidates “in the teeth of the epidemic,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. Read More
Designers of precision medicine trials need access to more data sources than traditional trials to refine the parameters of their studies and boost enrollment. Read More
The industry has been abuzz about risk-based monitoring (RBM) for much of the last decade, with the FDA indicating that it would like to see more sponsors give it a try. Read More
The research is clear: certified principal investigators (CPIs) and clinical research coordinators (CRCs) do better work compared with their peers who hold no certification. Much better work, in fact. Read More
