Data Monitoring and Complex Clinical Trials: Toward a Solution

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.

Realizing New Miracles: Gene Therapy Trends in 2024 and Beyond

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.