News By: Gary Cramer

As companies seek ways to bring their products to multiple markets, understanding those markets and their regulatory approval process is imperative. Choosing the most appropriate pathway can reduce the burden on both the sponsor and on the health authorities, and potentially expand access to more patients. One such pathway is the Access Consortium, which was formed in 2007 by four health authorities.

Studies of major depressive disorder require knowledge of its biology, the biomarkers that can be used as signals for efficacy, the optimal study design, and the availability of a study population that meets the protocol-specified inclusion and exclusion criteria.

Preventive antimicrobials are a promising solution to the antibiotic resistance problem, driven in part by recent advances in cell engineering technology and the important safety advantages of biologic drugs over their small-molecule cousins. However, not all of the barriers to wider adoption are scientific or biological—this novel therapeutic modality has important clinical, regulatory, and patient recruitment implications.

Barriers such as the sparsity of clinical trial sites in rural and underserved communities, inadequate patient reimbursement, and stringent inclusion/exclusion criteria hinder the enrollment of patients from diverse and underrepresented populations. This article outlines strategies for addressing some of the issues facing diversity enrollment, and is intended to stimulate conversation within the industry to ensure these barriers are addressed during the design and implementation of clinical trials.

Identifying what simulation can achieve for educational and research objectives that other modalities cannot achieve is essential. This review discusses whether simulation can be used to teach the research process, keeping in mind that the value of simulation can’t be determined by randomized trials alone. A qualitative approach to assessing the value of teaching research via simulation adds a well-rounded perspective.