Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency.

Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the design stage. At the time of initiating a clinical trial, there may be uncertainty about whether a biomarker is predictive or prognostic, and the trial design may need to account for this.

Transforming the Medical School Admissions Process: Prioritizing Team-Based Skills and Patient-Centered Values.

This article examines the need for reform in medical school admissions to better align with the collaborative and patient-centered nature of contemporary healthcare. Traditional admissions processes prioritize academic excellence, often neglecting essential interpersonal and team-based skills. We advocate for several strategies to address this gap.

Identifying and overcoming challenges in the EMA's qualification of novel methodologies: a two-year review.

The EMA Qualification of Novel Methodologies procedure qualifies methods, technologies and methodologies within a well-defined context of use in a pharma R&D context based on the evaluation of the presented scientific rationale and submitted data. This policy brief analyses QoNM submissions providing policy messages and recommendations to stakeholders on how to better prepare qualification applications in this regard. The recommendations include: 1.