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Clinical investigators and sites facing an FDA inspection need to know the difference between records the FDA is allowed to see and what document requests they can deny. Read More
Studies based on real-world evidence (RWE) don’t have to be a replacement for randomized clinical trials but rather an integral part of an overall trial strategy. Read More
This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. This issue features advice from WCG PFS Clinical’s Alexandra Opitz, lead clinical research analyst, and Amanda Miller, lead clinical research analyst/training program manager. Read More
As clinical trial executives continue to look at ways of speeding startup, one item that bears looking at is how clinical supply management is handled. Read More
Every year, WCG Clinical asks a number of thought leaders about what they think is coming in their areas of expertise for the coming year. In a two-part piece featured last week and this week, 10 subject matter experts from WCG and our partners share the important shifts, trends, regulations and priorities that will inform clinical trial development in 2020 and beyond. Read More
Nearly 30 percent of CROs’ clinical research monitors in the U.S. left their jobs in 2018, a 4 percentage point jump over previous years, according to a new global workforce survey. Read More
Every year, WCG Clinical asks a number of thought leaders about what they think is coming in their areas of expertise for the coming year. In a two-part piece that will be featured this week and next week, 10 subject matter experts from WCG and our partners share the important shifts, trends, regulations and priorities that will inform clinical trial development in 2020 and beyond.
The insights and predictions are grouped into six topics. They are: Scientific Advancements, Study Design and Study Conduct, Technology & Data, Public Policy & Regulatory Oversight, and Patient Advocacy.
An updated protocol writing tool developed by NIH and TransCelerate aims to help the clinical trials industry write better protocols. While it won’t necessarily help the clarity of writing, it does lay out a template to help guide the work.
Currently, 2,400 active users are developing protocols with the help of NIH’s e-Protocol Writer, an online tool that walks teams of investigators through protocol development, making sure they apply scientific standards required by NIH and the FDA as well as standards of good clinical practice, such as ICH E6 and E8.
The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication, GCP Questions, FDA Answers. Read More
The FDA yesterday proposed broadening its definition of the standard of evidence for effectiveness of investigational drugs and increasing the range of acceptable trial design, especially in rare disease research. Read More
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