Why Accurate Adverse Event Grading Matters in Early-Phase Oncology Studies In early-phase oncology trials, the distinction between a grade 2 and grade 3 adverse event (AE) can have significant implications. In studies using model-assisted dose-finding designs, inaccurate grading can influence...
Advances in oncology are expanding what is therapeutically possible while also introducing new complexity into clinical trial execution. Immune-based therapies, cellular therapies, bispecifics, and other emerging modalities can produce toxicity profiles that differ substantially from those associated with traditional cytotoxic...
Antibody-drug conjugates (ADCs) are transforming oncology development—but they also bring significant operational complexity. Narrow therapeutic windows, payload-driven toxicities, biomarker-dependent enrollment, and evolving regulatory expectations demand a different approach than traditional oncology trials. This practical guide helps sponsors navigate ADC development...
As cell and gene therapies continue to reshape treatment for complex and rare diseases, clinical research teams are navigating new operational realities. As these therapies advance, development strategies are also evolving to address new operational, regulatory, and evidence-generation challenges. Unlike many traditional therapies, cell and gene therapies may...
Artificial intelligence (AI) and real-world evidence (RWE) are playing a growing role across oncology development—from patient stratification and trial design to post-approval monitoring. As adoption accelerates, regulators are setting clearer expectations to ensure these tools are applied with transparency, rigor, and accountability. ...