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Latest From Research & Development

External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization

Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.

Clinical Trials Drug Approval Standards

Opioid Sponsors Enter 2019 At A Crossroads

Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the analgesics to market. 
Research & Development Neurology

What’s The Plan? US FDA Drug Development Tool Qualification Process Requires “Cultural Change”

FDA sees negotiating formal “qualification plan” as key process improvement that should ultimately accelerate pace for construction of biomarkers and other drug development tools. But it will take some getting used to.
Clinical Trials Drug Approval Standards

Patient Experience Data: US FDA Guidance Offers Other Ways To Share

Beyond submitting proposed guidances to FDA, stakeholders may develop patient registries, conduct natural history studies, and establish partnerships to help advance patient-focused drug development, agency suggests.

Clinical Trials Research & Development

Biomarker Qualification Can Focus On Risks, Benefits, And Expansions – US FDA

Draft guidance describes evidence needed to support qualification of a biomarker for use in drug development programs.

Clinical Trials Drug Approval Standards

Drug Development Tool Qualification: US FDA Offers Three-Step Review Process

FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle. 

Clinical Trials Research & Development
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