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.
Psychedelic therapy is at a crossroads. It could be the transformative tool we need to help patients for whom existing treatments are not enough. However, if we take only a few steps down the wrong path, it could also become yet another almost-breakthrough. What can we do to ensure psychedelic therapy’s future?
A glimpse into some of the facts and figures at play in the comings and goings of today's clinical research enterprise.
In this article, the authors aim to raise awareness by illustrating varied career pathways in clinical research; to “get the word out” for those who are exploring first-level careers, for anyone looking at second-level careers, and for seasoned clinical research professionals who are exploring new opportunities.