{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:35:03Z","timestamp":1792787703233,"version":"4.5.0"},"reference-count":45,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2025,1,25]],"date-time":"2025-01-25T00:00:00Z","timestamp":1737763200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,1,25]],"date-time":"2025-01-25T00:00:00Z","timestamp":1737763200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Grail Bio UK Ltd"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background\/aims:<\/jats:title>\n                    <jats:p>Certain sociodemographic groups are routinely underrepresented in clinical trials, limiting generalisability. Here, we describe the extent to which enriched enrolment approaches yielded a diverse trial population enriched for older age in a randomised controlled trial of a blood-based multi-cancer early detection test (NCT05611632).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Participants aged 50\u201377 years were recruited from eight Cancer Alliance regions in England. Most were identified and invited from centralised health service lists; a dynamic invitation algorithm was used to target those in older and more deprived groups. Others were invited by their general practice surgery (GP-based Participant Identification Centres in selected regions); towards the end of recruitment, specifically Asian and Black individuals were invited via this route, as part of a concerted effort to encourage enrolment among these individuals. Some participants self-referred, often following engagement activities involving community organisations. Enrolment took place in 11 mobile clinics at 151 locations that were generally more socioeconomically deprived and ethnically diverse than the England average. We reduced logistical barriers to trial participation by offering language interpretation and translation and disabled access measures. After enrolment, we examined (1) sociodemographic distribution of participants versus England and Cancer Alliance populations, and (2) number needed to invite (NNI; the number of invitations sent to enrol one participant) by age, sex, index of multiple deprivation (IMD) and ethnicity, and GP surgery-level bowel screening participation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Approximately 1.5 million individuals were invited and 142,924 enrolled (98% via centralised health service lists\/invitation algorithm) in 10.5 months. The enrolled population was older and more deprived than the England population aged 50\u201377 years (73.3% vs 56.8% aged 60\u201377 years; 42.3% vs 35.3% in IMD groups 1\u20132). Ethnic diversity was lower in the trial than the England population (1.4% vs 2.8% Black; 3.3% vs 5.3% Asian). NNI was highest in Black (32.8), Asian (28.2) and most-deprived (21.5) groups, and lowest in mixed ethnicity (8.1) and least-deprived (4.6) groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Enrolment approaches used in the NHS-Galleri trial enabled recruitment of an older, socioeconomically diverse participant population relatively rapidly. Compared with the England and Cancer Alliance populations, the enrolled population was enriched for those in older age and more deprived groups. Better ethnicity data availability in central health service records could enable better invitation targeting to further enhance ethnically diverse recruitment. Future research should evaluate approaches used to facilitate recruitment from underrepresented groups in clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17407745241302477","type":"journal-article","created":{"date-parts":[[2025,1,29]],"date-time":"2025-01-29T12:18:40Z","timestamp":1738153120000},"page":"227-238","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["NHS-Galleri trial: Enriched enrolment approaches and sociodemographic characteristics of enrolled participants"],"prefix":"10.1177","volume":"22","author":[{"given":"Charles","family":"Swanton","sequence":"first","affiliation":[{"name":"University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Velicia","family":"Bachtiar","sequence":"additional","affiliation":[{"name":"GRAIL Bio UK Ltd., GRAIL, Inc., London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Mathews","sequence":"additional","affiliation":[{"name":"King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6327-4357","authenticated-orcid":false,"given":"Adam R","family":"Brentnall","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Lowenhoff","sequence":"additional","affiliation":[{"name":"King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jo","family":"Waller","sequence":"additional","affiliation":[{"name":"King\u2019s College London, London, UK"},{"name":"Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martine","family":"Bomb","sequence":"additional","affiliation":[{"name":"NHS England, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"McPhail","sequence":"additional","affiliation":[{"name":"NHS England, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Pinches","sequence":"additional","affiliation":[{"name":"NHS England, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Smittenaar","sequence":"additional","affiliation":[{"name":"GRAIL Bio UK Ltd., GRAIL, Inc., London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Hiom","sequence":"additional","affiliation":[{"name":"GRAIL Bio UK Ltd., GRAIL, Inc., London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard D","family":"Neal","sequence":"additional","affiliation":[{"name":"University College London, London, UK"},{"name":"University of Exeter, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1509-8744","authenticated-orcid":false,"given":"Peter","family":"Sasieni","sequence":"additional","affiliation":[{"name":"King\u2019s College London, London, UK"},{"name":"Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,1,25]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"e_1_3_3_3_2","unstructured":"Cancer Research UK. Cancer mortality by deprivation https:\/\/www.cancerresearchuk.org\/health-professional\/cancer-statistics\/incidence\/all-cancers-combined#heading-Three (2021 accessed 11 November 2023)."},{"key":"e_1_3_3_4_2","unstructured":"Cancer Research UK and National Cancer Intelligence Network. Deprivation Gradient for Cancer Mortality. https:\/\/www.cancerresearchuk.org\/health-professional\/cancer-statistics\/mortality\/deprivation-gradient (2024 accessed 02 January 2025)."},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41416-021-01279-z"},{"key":"e_1_3_3_6_2","unstructured":"NHS Digital. Cancer registration statistics England: 2020 https:\/\/www.ons.gov.uk\/peoplepopulationandcommunity\/healthandsocialcare\/conditionsanddiseases\/bulletins\/cancerregistrationstatisticsengland\/2017 (2023 accessed 11 July 2024)."},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0253854"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41416-022-01718-5"},{"key":"e_1_3_3_9_2","unstructured":"Office for National Statistics. Ethnic differences in life expectancy and mortality from selected causes in England and Wales: 2011 to 2014 https:\/\/www.ons.gov.uk\/peoplepopulationandcommunity\/birthsdeathsandmarriages\/lifeexpectancies\/articles\/ethnicdifferencesinlifeexpectancyandmortalityfromselectedcausesinenglandandwales\/2011to2014#ethnic-breakdown (2021 accessed 25 October 2023)."},{"key":"e_1_3_3_10_2","unstructured":"Office for National Statistics. Mortality from leading causes of death by ethnic group England and Wales https:\/\/www.ons.gov.uk\/peoplepopulationandcommunity\/birthsdeathsandmarriages\/deaths\/articles\/mortalityfromleadingcausesofdeathbyethnicgroupenglandandwales\/2012to2019 (2019 accessed 02 January 2025)"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-062079"},{"key":"e_1_3_3_12_2","unstructured":"GOV.UK. People living in deprived neighbourhoods https:\/\/www.ethnicity-facts-figures.service.gov.uk\/uk-population-by-ethnicity\/demographics\/people-living-in-deprived-neighbourhoods\/latest\/#overall-most-deprived-10-of-neighbourhoods-by-ethnicity (2020 accessed 2 July 2024)."},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/pon.5890"},{"key":"e_1_3_3_14_2","unstructured":"National Institute for Health and Care Research. Research & inclusion strategy 2022\u20132027 https:\/\/www.nihr.ac.uk\/about-us\/who-we-are\/research-inclusion\/strategy-2022-27 (2022 accessed 7 December 2023)."},{"key":"e_1_3_3_15_2","unstructured":"National Institute for Health and Care Research. Guidance from the NIHR-INCLUDE project http:\/\/www.nihr.ac.uk\/documents\/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project\/25435 (2020 accessed 25 October 2023)."},{"key":"e_1_3_3_16_2","unstructured":"Trial Forge. A systematic approach to making trials more efficient https:\/\/www.trialforge.org\/ (2024 accessed 2 July 2024)."},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-020-01149-x"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2019.1870"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1093\/ageing\/afab282"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21638"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2021.05.806"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.3390\/cancers14194818"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)01700-2"},{"key":"e_1_3_3_24_2","unstructured":"Office for National Statistics. Ethnic group national identity and religion https:\/\/www.ons.gov.uk\/methodology\/classificationsandstandards\/measuringequality\/ethnicgroupnationalidentityandreligion (2023 accessed 25 October 2023)."},{"key":"e_1_3_3_25_2","unstructured":"NHS Digital. NHS DigiTrials https:\/\/digital.nhs.uk\/services\/nhs-digitrials (2023 accessed 25 October 2023)."},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1177\/17407745231167369"},{"key":"e_1_3_3_27_2","unstructured":"GOV.UK. English indices of multiple deprivation2019 https:\/\/www.gov.uk\/government\/statistics\/english-indices-of-deprivation-2019 (2019 accessed 25 October 2023)."},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1038\/s43587-022-00277-x"},{"key":"e_1_3_3_29_2","unstructured":"Department of Health & Social Care. SHAPE https:\/\/shapeatlas.net\/ (2023 accessed 25 October 2023)."},{"key":"e_1_3_3_30_2","unstructured":"Public Health England. 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