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FDA Unveils Pilot Program to Promote Innovative Trial Design

As part of its ongoing effort to promote complex innovative trial designs (CIDs), the U.S. Food and Drug Administration (FDA) just unveiled an expansive pilot meeting program designed to let sponsors discuss specifics with agency experts. The CID pilot meeting program is for innovative designs that require simulations. There are several parameters, however. For example, […]

Suit and Tie

The Time is Now to Professionalize the Clinical Trial Workforce

When you stop and think about it, the lack of standards and core competencies in the clinical trial industry is stunning. Mechanics must get licenses. Masseuses must earn certifications. Jessica the hairdresser was required to pass performance tests before she was allowed to set up shop at her chair. Joining the clinical trial workforce? It’s […]

FDA Guidance Calls for Sponsors to Limit Use of Placebo-Controlled Clinical Trial Design

FDA Pushes Back on Placebo Inclusion in Some Cancer Trials

In a new guidance document, the U.S. Food and Drug Administration (FDA) takes direct aim at some of the ethical and practical issues complicating use of placebos and blinding practices in trials focusing on treatment of hematologic malignancy and oncologic diseases. FDA calls for sponsors to use a placebo-controlled design only in selected circumstances (e.g., […]

Amanda Wright, Executive Director, Greater Gift

Haphazard Workforce Pathways Obstruct Pipeline of Incoming Trial Professionals

Boston drivers are frustrated and confused by the city’s notoriously illogical road network. Streets end for no apparent reason, then magically reappear under the same name a few blocks later. Others meander into dead ends or come together in odd configurations to produce intersections of epically confusing proportions. Allegedly, the roads are random in part […]

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Is it Time for a Major Reexamination of Inclusion/Exclusion Criteria?

Stringent exclusion criteria sometimes have the unintended consequence of producing clinical trials that fail to represent the “broader patient populations that use approved products,” according to a new summary of a U.S. Food and Drug Administration (FDA) public workshop bringing together voices across the care delivery spectrum. Inclusion and exclusion criteria aren’t matters to be […]