Accelerating evidence generation: Addressing critical challenges and charting a path forward.

Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25-26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs.

New Flexon-based reagents for tissue-specific Auxin-Inducible Degradation and for characterizing Cre and Flp drivers in .

A Flexon stop cassette interrupts translation of a coding region until it is excised by a recombinase to allow for gene expression. We have expanded options for Auxin-Inducible Degradation by generating Flexon-based transgenes for tissue-specific expression of the ubiquitin ligase substrate recognition component TIR1 or the variant TIR1(F79G) after excision of the Flexon by Cre recombinase. We also describe Flexon-based tester transgenes to facilitate gathering accurate information about the expression pattern of Cre and Flp recombinase drivers that can be used in conjunction with any conditional expression reagents that utilize these recombinases.

The Case for Access to Data Monitoring Committee Charters.

AbstractClinical trials investigating novel or high-risk interventions often use data monitoring committees (DMCs) to ensure that the participants' best interests are safeguarded. The typical DMC charter describes procedures by which the DMC operates, including important details concerning organizational structure, membership, meeting frequency, statistical monitoring guidelines, and contents of DMC reports for interim review. These charters, however, are not routinely publicly available; in some cases, their access could be important to the interpretation of trial results.