Insights

This paper describes the practice changes that clinical research nurses (CRNs) may anticipate when decentralized clinical trial participation is involved, considering the CRN as a supportive role for clinical nurse care delivery guidance, identifying trial participants, and obtaining safety-related study information to inform care and ethical considerations.

Becoming an independent consultant in clinical research requires taking a number of steps and dwelling on several considerations. This article provides a comprehensive look at professional development interwoven with the author's own experience working in clinical research as an independent consultant/contractor, including how he (and others) entered the profession, built and maintained his experience base, and launched his own LLC, along with his perspectives on professional development as it relates to clinical research.

One-size-fits-all approaches to evaluating accumulating data are not feasible when working with multiple variables, whether they be multiple endpoints, multiple treatments, or both. Ensuring a robust framework upon which to base stop/go calculations is essential to protecting participant safety whilst accelerating access to life-changing new treatments. The weight of responsibility carried by data monitoring committees is not insignificant, so it is important that these complexities are worked through.

There are many reasons to be excited about the field of advanced medicinal therapeutic products or cell and gene therapies. There are, however, also issues with these products. Trends in the near-term will focus on ways to address current limitations, be those due to safety, immunogenicity issues, targeting challenges, dosing issues, or regulatory and payer barriers. The article explores four areas of focus for the year ahead.