Woodcock Open To Endpoint Flexibility For Rare Diseases
Acting US FDA Commissioner also touts master protocols’ potential for rare diseases, arguing patient-funded foundations could overcome sponsor hesitancy to collaborate with potential rivals.
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US FDA Guidance Aims To Tackle Challenges In Multi-Endpoint Trials
Final guidance targets the ‘multiplicity problem.’ At about half the length of the 2017 draft, the final removes some sections, truncates other and drops several examples.
Trials In Focus: FDA Guidance Aims To Tackle Challenges In Multi-Endpoint Trials
Beam Therapeutics also announced that it dosed the first patient in its Phase I/II sickle cell disease trial; Vyne stepped into the increasingly competitive vitiligo space, while Tracon moved further into sarcomas in its checkpoint inhibitor program, and Telix started a small trial of its drug in brain cancer.
COVID-19 Should Force ‘Soul Searching’ Over Fragmented US Clinical Trials System, Woodcock Says
Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.