Redefining clinical trial strategic design to support drug approval in medical oncology

G Antonarelli¹, J M Pérez-García², M Gion³, H Rugo⁴, P Schmid⁵, A Bardia⁶, S Hurvitz⁷, N Harbeck⁸, S M Tolaney⁹, G Curigliano¹, A Llombart-Cussac¹⁰, J Cortés¹¹

Affiliations

¹ Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan; Department of Oncology and Haematology (DIPO), University of Milan, Milan, Italy.
² Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, USA; International Breast Cancer Center (IBCC), Pangaea Oncology, Quirón Group, Barcelona.
³ Hospital Universitario Ramón y Cajal, Madrid, Spain; IOB Madrid, Institute of Oncology, Hospital Beata María Ana, Madrid.
⁴ Department of Medicine, University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, USA.
⁵ Barts Cancer Institute, Queen Mary University of London, London, UK.
⁶ University of California Los Angeles (UCLA), Los Angeles.
⁷ Fred Hutchinson Cancer Center, University of Washington School of Medicine, Seattle, USA.
⁸ Breast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany.
⁹ Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
¹⁰ Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Arnau de Vilanova Hospital, Universidad Católica de Valencia, Valencia.
¹¹ Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, USA; IOB Madrid, Institute of Oncology, Hospital Beata María Ana, Madrid; Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain; Oncology Department, Hospital Universitario Torrejón, Ribera Group, Madrid, Spain. Electronic address: javier.cortes@maj3.health.

PMID: 40086733
DOI: 10.1016/j.annonc.2025.03.005

Review

Redefining clinical trial strategic design to support drug approval in medical oncology

G Antonarelli et al. Ann Oncol. 2025 Jun.

. 2025 Jun;36(6):645-650.

doi: 10.1016/j.annonc.2025.03.005. Epub 2025 Mar 12.

Authors

G Antonarelli¹, J M Pérez-García², M Gion³, H Rugo⁴, P Schmid⁵, A Bardia⁶, S Hurvitz⁷, N Harbeck⁸, S M Tolaney⁹, G Curigliano¹, A Llombart-Cussac¹⁰, J Cortés¹¹

Affiliations

¹ Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan; Department of Oncology and Haematology (DIPO), University of Milan, Milan, Italy.
² Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, USA; International Breast Cancer Center (IBCC), Pangaea Oncology, Quirón Group, Barcelona.
³ Hospital Universitario Ramón y Cajal, Madrid, Spain; IOB Madrid, Institute of Oncology, Hospital Beata María Ana, Madrid.
⁴ Department of Medicine, University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, USA.
⁵ Barts Cancer Institute, Queen Mary University of London, London, UK.
⁶ University of California Los Angeles (UCLA), Los Angeles.
⁷ Fred Hutchinson Cancer Center, University of Washington School of Medicine, Seattle, USA.
⁸ Breast Center, Department of Obstetrics and Gynecology and CCC Munich, LMU University Hospital, Munich, Germany.
⁹ Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
¹⁰ Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Arnau de Vilanova Hospital, Universidad Católica de Valencia, Valencia.
¹¹ Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain; Medica Scientia Innovation Research (MEDSIR), Ridgewood, USA; IOB Madrid, Institute of Oncology, Hospital Beata María Ana, Madrid; Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, Madrid, Spain; Oncology Department, Hospital Universitario Torrejón, Ribera Group, Madrid, Spain. Electronic address: javier.cortes@maj3.health.

PMID: 40086733
DOI: 10.1016/j.annonc.2025.03.005

Abstract

Randomized clinical trials represent the gold standard for the introduction of innovative therapies in medical oncology, and they provide the highest level of evidence to ascertain the clinical activity of new drugs or novel combinations. However, the current infrastructure of clinical trials supporting innovative drug approvals is challenged by an increased body of knowledge concerning tumor biology and therapy resistance, a fast-growing armamentarium of novel anticancer compounds, an impressively upscaled data analysis capacity, as well as increasing costs related to clinical trials management. In this scenario, modern clinical trial designs need to evolve to expedite new drug approvals by tailoring patients' treatment strategies according to their medical needs. Balanced, patient-oriented clinical trial designs are eagerly warranted to increase their efficiency, to include the fast pace of technological innovations and scientific discoveries, and, ultimately, to face the challenges of the modern medical oncology field.

Keywords: clinical trials; medical oncology; regulatory approval; strategic design.

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Redefining clinical trial strategic design to support drug approval in medical oncology

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Redefining clinical trial strategic design to support drug approval in medical oncology

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Medical