Investigative sites of all sizes, from part-time physician-run sites to large dedicated research centers, report a rebound in operating conditions, according to a new CenterWatch analysis, yet sites from each subgroup indicate they have concerns about the stability of the clinical research environment. The size of an individual grant for industry sponsored trials has either declined or remained flat for sites of all sizes and types, and a majority of sites in all subgroups, except for those in the largest and least experienced segments, won’t hire new staff this year…
Risk-based monitoring slow to catch on with industry
It’s estimated that the cost of physically sending monitors to all investigative sites at regular intervals, a model the industry itself developed and has adhered to for about a decade, eats up one-third to one-half of study budgets. Now, posited the FDA and European Medicines Agency (EMA), the industry has the technology to handle most monitoring centrally. Thus, risk-based monitoring could save the industry millions in monitoring costs. But so far the sponsor community—slow to change and also fearing the regulatory bodies may not truly mean what they say—is not leaping to adopt the new concept…
Eye on Millennium
Millennium, The Takeda Oncology Company, is a biopharmaceutical genomics company focused exclusively on oncology. Millennium discovers and develops novel treatments, applying world-class recombinant technology to a wide variety of oncology disease targets. The company’s largest commercial success to date has been Velcade (bortezomib), developed through Nobel Prize-winning protein homeostasis science and now approved in more than 87 countries for multiple myeloma and relapsed mantle cell lymphoma…
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