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Measurable residual disease (MRD) is a promising surrogate end point candidate, providing a sensitive and quantitative assessment of disease burden. Numerous studies have demonstrated that negative MRD status\u2014across diverse methodologies, assessment timepoints and thresholds, patient subgroups, and clinical settings\u2014independently predicts improved survival. Although MRD can inform therapeutic decisions at the patient level, its formal integration as a primary surrogate end point in regulatory frameworks for clinical trials requires rigorous validation. MRD Partnership and Alliance in AML Clinical Treatment (MPAACT) is a research consortium among industry and academic leaders. MPAACT actively engages with regulatory agencies, health technology assessment bodies, technology vendors, and patient groups to establish a pathway for validating MRD as a surrogate end point in AML clinical trials. For the current article, the authors reviewed the status of MRD assessment, its use in recent clinical trials, current MRD assessment methodologies, standardization, regulatory guidance, statistical approaches, and patient access considerations necessary for MRD to become a surrogate clinical trial end point. The extensive collaboration between MPAACT, global industry, and academic partners\u2014including data sharing and resource integration\u2014underscores the collective commitment to advancing AML therapies. Establishing MRD as a surrogate end point could accelerate the development and approval of innovative treatments, ultimately improving patient outcomes.<\/jats:p>","DOI":"10.1002\/cncr.35960","type":"journal-article","created":{"date-parts":[[2025,6,27]],"date-time":"2025-06-27T07:03:43Z","timestamp":1751007823000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Measurable residual disease (MRD) as a surrogate end point for clinical drug approval in acute myeloid leukemia (AML): Perspectives from the MRD Partnership and Alliance in AML Clinical Treatment Consortium"],"prefix":"10.1002","volume":"131","author":[{"given":"Michael","family":"Boyiadzis","sequence":"first","affiliation":[{"name":"Genentech  South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew H.","family":"Wei","sequence":"additional","affiliation":[{"name":"Peter MacCallum Cancer Center and Royal Melbourne Hospital  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Paiva","sequence":"additional","affiliation":[{"name":"Cancer Center Clinica Universidad de Navarra Cima Universidad de Navarra Instituto de Investigaci\u00f3n Sanitaria de Navarra  Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie D.","family":"Freeman","sequence":"additional","affiliation":[{"name":"Institute of Immunology and Immunotherapy College of Medical and Health University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gertjan","family":"Kaspers","sequence":"additional","affiliation":[{"name":"Princess M\u00e1xima Cancer Center for Pediatric Oncology  Utrecht Netherlands"},{"name":"Emma Children\u2019s Hospital Amsterdam University Medical Center Vrije Universiteit Amsterdam  Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brenda","family":"Chyla","sequence":"additional","affiliation":[{"name":"AbbVie  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Hersey","sequence":"additional","affiliation":[{"name":"Translational Sciences and Diagnostics Bristol Myers Squibb  Summit New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reshma","family":"Patel","sequence":"additional","affiliation":[{"name":"Johnson and Johnson Innovative Medicine Global Regulatory Affairs  High Wycombe Buckinghamshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Maloney","sequence":"additional","affiliation":[{"name":"Regulatory Affairs Johnson and Johnson  New Brunswick New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie\u2010Helene","family":"Blanchet Zumofen","sequence":"additional","affiliation":[{"name":"F. 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