reakthrough therapies are rapidly outpacing the limits of traditional clinical trial designs. Cell and gene therapies, antibody-drug conjugates, bispecific antibodies, tyrosine kinase inhibitors, and immuno-oncology modulators represent just a fraction of the expanding therapeutic arsenal, signaling a new era of innovation in oncology drug development. The cost of progress is steep: the average investment to bring an oncology drug to market now exceeds $1.2 billion. Amid rising costs and complex development pathways, the biopharmaceutical industry faces a critical juncture: innovate to succeed in oncology, or risk downsizing—or even abandoning—oncology portfolios altogether.

Transforming Oncology Drug Development

Statisticians and data scientists are at the forefront of transforming oncology drug development, unlocking the potential of emerging therapies while tackling the complex challenges of modern clinical research. Without faster, smarter, more agile approaches, life-saving treatments may remain out of reach for the cancer patients who need them most.

To address this challenge, DIA’s peer-reviewed journal Therapeutic Innovation & Regulatory Science (TIRS) has launched a Special Collection focused on innovative methods in oncology clinical trials and is soliciting submission of papers for this ongoing Collection.

The Collection aims to spotlight practical, forward-thinking strategies, from biomarker-driven study designs to real-world data integration and AI-powered analytics, that can help modernize oncology development pipelines. This Collection offers more than academic insights. Whether you’re a trial designer, regulator, clinician, or data scientist, the real-world cases and cross-functional innovations showcased can inform your work and inspire new approaches to navigate through complex challenges in oncology drug development.

Voice Across the Oncology Community

Submissions remain open for the foreseeable future, and we welcome voices from across the oncology community. Whether you’re advancing flexible adaptive designs, developing master protocols, leveraging external data to inform regulatory decisions, or applying AI tools in clinical research, your insights are vital to shaping a more agile and patient-centered future.
Learn more and submit your paper: https://link.springer.com/collections/bihcbabebc.