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 video interview, Gaynor Anders, chief delivery officer at Trialbee, identifies organizational silos, siloed budgets, and a study-centric mindset as the biggest barriers to shifting from ...

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 ...

In a recent video interview with Applied Clinical Trials, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discussed the collaborative work underway with FDA and CTTI to ...

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 ...

Functional unblinding is a central threat to validity; alternative controls, central blinded raters, blinding/expectancy questionnaires, and robust concordant endpoints are recommended to mitigate ...

Bringing the Voice of Clinical Practice and Patients into Drug Development ...

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 ...

Experts discuss the use of subject diaries and the way researchers can comply with applicable regulations and guidelines. Subject diaries are used in approximately 25% of all clinical trials. 1 They ...