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Suggested endpoints include reductions in late-stage cancer incidence and eligibility for curative therapy after diagnosis, supported by earlier trial designs that complement mortality to assess benefits and harms more rapidly.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/research-report/","Research & 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\nBioPharma Business & Europe, GRAIL Bio UK Ltd., London, UK  \nKeywords  \nalternative endpoints; cancer screening; early detection of cancer; liquid biopsy  \nCorrespondence  \nH. Kumar, BioPharma Business & Europe, GRAIL Bio UK Ltd. , 210 Euston Road, London NW1 2DA, UK  \nE-mail: [hkumar@grailbio.com](hkumar@grailbio.com)  \n(Received 28 May 2024, accepted 25 June 2024, available online 6 July 2024)  \ndoi:10 . 1002/1878-0261 .13697  \nThe reliance on mortality endpoints in cancer screening trials is not always compatible with the need to accelerate progress in outcomes for patient and public benefit. Evaluation of novel cancer screening technologies, such as multi-cancer early detection (MCED) tests, could be expedited by using alternative metrics that are measurable earlier than mortality. These include endpoints based on cancer stage at diagnosis, such as reduction in late-stage cancer incidence, and endpoints following cancer diagnosis, such as eligibility for curative therapy. Innovative trial designs with earlier measures that complement cancer mortality are needed to realise the potential benefits of novel screening technologies such as MCEDs more rapidly.  \n1. Introduction  \nCancer is the leading cause of death in high-income countries (HICs) [1] . The World Health Organization recently predicted that nearly 11 million new cancer cases will occur in HICs in 2050, a 37% increase from the 8 million estimated in 2022 [2] . The vast majority of cancer deaths are associated with late stage at diagnosis, usually after patients present with symptoms. Detecting cancer at an early stage, and ideally prior to symptomatic presentation, when there are more treatment options and greater potential for cure, can help reduce this unacceptably high cancer burden. It is therefore imperative that patients benefit from new, safe, and effective tech  \nnologies for earlier asymptomatic cancer detection.  \nHistorically, the sequence of evidence generation for cancer screening tests has taken decades, from development and validation of a new technology, through clinical trials assessing utility and publication of their effectiveness, to implementation at population scale. One reason for this prolonged time frame is the requirement for evidence of a reduction in cancer mortality, which necessitates observation of very large study  \npopulations and up to 20 years of follow-up. Cancer’s rising human and economic toll demands a sense of urgency as we consider novel approaches to screening.  \nThe advent of multi-cancer early detection (MCED) brings unique challenges and opportunities for evaluating the benefits and harms of screening. Given the rapid pace of technological development in blood-based assays, sequencing, and artificial intelligence, a new and rigorous approach applicable to the MCED paradigm is required to efficiently assess its effectiveness [3] . The use of outcomes that are measurable earlier than mortality, such as reduction in late-stage cancer incidence [4], could meaningfully expedite the read-out of trials and thus progress in cancer screening.  \n2. The expectation, the reality, and the alternative  \nIn response to the surge in biomarker research in the late 1990s, a blueprint was established to standardise the phases of screening test development, from  \nAbbreviations  \nHICs, high-income countries; MCED, multi-cancer early detection; NSC, UK National Screening Committee; RCT, randomised controlled trial; USPSTF, US Preventive Services Task Force.  \nMolecular Oncology 18 (2024) 1817–1820 ª 2024 GRAIL, Inc. Molecular Oncology published by John Wiley & Sons Ltd on behalf of Federation of European Biochemical Societies.  \nThis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.  \n1817  \nAlternatives to mo","cbCaieIzjr3ZLK2N","https://ap.wps.com/l/cbCaieIzjr3ZLK2N","pdf",104380,"English","# Introduction\n## The expectation, the reality, and the alternative\n## Alternatives to mortality in cancer screening","[{\"question\":\"Why are mortality endpoints difficult for cancer screening trials that aim for faster progress?\",\"answer\":\"Mortality outcomes require large populations and long follow-up periods, which can delay trial read-outs and slows progress toward patient and public benefit.\"},{\"question\":\"What alternative endpoints can be used instead of mortality in cancer screening trials?\",\"answer\":\"Alternatives include reductions in late-stage cancer incidence and post-diagnosis endpoints such as eligibility for curative therapy.\"},{\"question\":\"How does the multi-cancer early detection (MCED) approach change evaluation needs?\",\"answer\":\"MCED introduces challenges requiring outcomes measurable earlier than mortality, enabling earlier assessment of effectiveness while still considering benefits and harms.\"}]","Alternative endpoints to mortality in cancer screening trials - Sir Harpal Kumar | PDF",1789997675]