Recent articles (09.2017)
- Admin
- Sep 13, 2017
- 2 min read
More sites need to take advantage of industry standards. Sites of excellence understand that using internal and industry-standard procedures, training, forms, checklists, metrics, certifications, etc., not only save time, but also improve quality....
....Sounds great, so what’s holding us back? Fear of change. It’s easier to just keep doing things the same way you did them yesterday. ...
The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE)
But the question is “what is the best metric to set the plan?”. Instead of the “time to achieve the 50th percentile of sites initiated” we would advocate using a site initiation rate benchmark.
In conclusion, there has been a decline in the number of trials being funded over time, explained in part by a relatively constant budget, increases in trial costs, or other factors that cannot be quantified. National Institutes of Health–funded trials are relatively small and tend to be single-centered.
Over the past few months, FDA has announced a number of broad policy efforts to address public health opportunities in areas such as regenerative medicine, tobacco products, and access to affordable medicines.
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