Education-centric outreach strengthens cognitive trust but underperforms when sponsor engagement is transactional and not ...

In today's ACT Brief, we examine the FDA's paused real-time complete response letter release policy, why programmatic patient ...

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, explains why the industry's protocol-centric recruitment model has persisted so long and what a shift toward programmatic, ...

In this Q&A, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discusses the collaborative work underway with FDA and CTTI to explore selective safety data collection as ...

Merck’s Phase III KEYNOTE-B96 trial shows significant overall and progression-free survival gains with Keytruda plus chemotherapy in patients with PD-L1–positive, platinum-resistant recurrent ovarian ...

In today's ACT Brief, we examine how local-first approaches can redesign clinical trial communication, quantitative evidence on risk-based quality management returns, and FDA approval of an oral ...

Two classic translational blocks are compounded by an execution gap characterized by weak cross-functional mobilization, slow decision-making, and inability to operationalize corrective actions ...

Final guidance suggests sponsors select two doses for Phase II trials with additional data requirements. As oncology drugs advance from cytotoxic chemotherapies to targeted treatments, newly finalized ...

AI-Enabled Sites and the Future of Trial Planning: Q&A with Liz Beatty, Inato ...

Unlocking the full potential of artificial intelligence requires these stakeholders to ensure their data are accessible and secure. Over the past two years, generative artificial intelligence (AI) has ...

An examination of recent failures in Phase III studies and innovative approaches to reduce risk. Thomas Henry Huxley (1825-1895) once stated, “The great tragedy of science-the slaying of a beautiful ...

Ozempic reduced major adverse cardiovascular events by 23% compared to dulaglutide in older adults with type 2 diabetes and cardiovascular disease. REACH study used real-world data to address evidence ...