{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T04:03:43Z","timestamp":1778904223294,"version":"3.51.4"},"reference-count":35,"publisher":"MDPI AG","issue":"22","license":[{"start":{"date-parts":[[2021,11,18]],"date-time":"2021-11-18T00:00:00Z","timestamp":1637193600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background: Concern exists that the clinical trial populations differ from respective cancer populations in terms of their age distribution affecting the generalizability of the results, especially in underrepresented minorities. We hypothesized that the clinical trials that do not report race are likely to suffer from a higher degree of age disparity. Methods: Food and Drug Administration (FDA) drug approvals from July 2007 to June 2019 were reviewed to identify oncology approvals, and trials with age details were selected. The outcomes studied were the weighted mean difference in age between the clinical trial population and real-world population for various cancers, the prevalence of race reporting and association of age and race reporting with each other. Results: Of the 261 trials, race was reported in 223 (85.4%) of the trials, while 38 trials (14.6%) had no mention of race. Race reporting improved minimally over time: 29 (85.3%) in 2007\u20132010 vs. 49 (80.3%) in 2011\u20132014 vs. 145 (85.4%) during the period 2015\u20132019 (p-value = 0.41). Age discrepancy between the clinical trial population and the real-world population was higher for studies that did not report race (mean difference \u22128.8 years (95% CI \u221212.6 to \u22125.0 years)) vs. studies that did report it (mean difference \u22125.1 years, (95% CI \u22126.4 to \u22123.7 years), p-value = 0.04). Conclusion: The study demonstrates that a significant number of clinical trials leading to cancer drug approvals suffer from racial and age disparity when compared to real-world populations, and that the two factors may be interrelated. We recommend continued efforts to recruit diverse populations.<\/jats:p>","DOI":"10.3390\/cancers13225770","type":"journal-article","created":{"date-parts":[[2021,11,18]],"date-time":"2021-11-18T08:53:56Z","timestamp":1637225636000},"page":"5770","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Landmark Cancer Clinical Trials and Real-World Patient Populations: Examining Race and Age Reporting"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3636-0353","authenticated-orcid":false,"given":"Thejus","family":"Jayakrishnan","sequence":"first","affiliation":[{"name":"Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland, OH 44106, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sonikpreet","family":"Aulakh","sequence":"additional","affiliation":[{"name":"Departments of Internal Medicine and Neurosciences, West Virginia University, Morgantown, WV 26506, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3604-5353","authenticated-orcid":false,"given":"Mizba","family":"Baksh","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kianna","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Mayo Clinic Alix School of Medicine, Rochester, MN 55905, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meghna","family":"Ailawadhi","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8144-1892","authenticated-orcid":false,"given":"Ayesha","family":"Samreen","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ricardo","family":"Parrondo","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taimur","family":"Sher","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vivek","family":"Roy","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rami","family":"Manochakian","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8765-9649","authenticated-orcid":false,"given":"Aneel","family":"Paulus","sequence":"additional","affiliation":[{"name":"Division of Cancer Biology, Mayo Clinic, Jacksonville, FL 32224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asher","family":"Chanan-Khan","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"},{"name":"Division of Hematology-Oncology, St. Vincent\u2019s Cancer Center, Jacksonville, FL 32224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sikander","family":"Ailawadhi","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL 100151, USA"},{"name":"Division of Cancer Biology, Mayo Clinic, Jacksonville, FL 32224, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,11,18]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e191870","DOI":"10.1001\/jamaoncol.2019.1870","article-title":"Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018","volume":"5","author":"Loree","year":"2019","journal-title":"JAMA Oncol."},{"key":"ref_2","first-page":"5977","article-title":"Age and Race Distribution in Patients in Phase III Oncology Clinical Trials","volume":"12","author":"Gopishetty","year":"2020","journal-title":"Am. J. Transl. Res."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"e000773","DOI":"10.1136\/esmoopen-2020-000773","article-title":"Gender and Sex Disparity in Cancer Trials","volume":"5","author":"Lee","year":"2020","journal-title":"ESMO Open"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1200\/EDBK_100021","article-title":"Enrollment of Racial Minorities in Clinical Trials: Old Problem Assumes New Urgency in the Age of Immunotherapy","volume":"39","author":"Nazha","year":"2019","journal-title":"Am. Soc. Clin. Oncol. Educ. Book"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2720","DOI":"10.1001\/jama.291.22.2720","article-title":"Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities","volume":"291","author":"Murthy","year":"2004","journal-title":"JAMA"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1016\/j.trecan.2017.02.002","article-title":"Racial Differences in Cancer Susceptibility and Survival: More Than the Color of the Skin?","volume":"3","author":"Dotto","year":"2017","journal-title":"Trends Cancer"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1076","DOI":"10.1634\/theoncologist.2017-0592","article-title":"Representation of Minorities and Elderly Patients in Multiple Myeloma Clinical Trials","volume":"23","author":"Duma","year":"2018","journal-title":"Oncologist"},{"key":"ref_8","unstructured":"(2021, April 10). SEER Cancer Statistics Review, 1975\u20132010\u2014Previous Version\u2014SEER Cancer Statistics Review, Available online: https:\/\/seer.cancer.gov\/archive\/csr\/1975_2010\/index.html."},{"key":"ref_9","unstructured":"(2021, April 10). Cancer Statistics\u2014National Cancer Institute, Available online: https:\/\/www.cancer.gov\/about-cancer\/understanding\/statistics."},{"key":"ref_10","unstructured":"(2021, April 10). Key Statistics for Acute Myeloid Leukemia (AML). Available online: https:\/\/www.cancer.org\/cancer\/acute-myeloid-leukemia\/about\/key-statistics.html."},{"key":"ref_11","unstructured":"(2020, August 01). Available online: Topic_med_age.Pdf."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"5519","DOI":"10.1002\/cam4.3237","article-title":"Recent Survival Trends in Diffuse Large B-Cell Lymphoma\u2013\u2013Have We Made Any Progress beyond Rituximab?","volume":"9","author":"Epperla","year":"2020","journal-title":"Cancer Med."},{"key":"ref_13","unstructured":"(2021, April 10). Multiple Myeloma\u2014Risk Factors. Available online: https:\/\/www.cancer.net\/cancer-types\/multiple-myeloma\/risk-factors."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"e19038","DOI":"10.1200\/JCO.2016.34.15_suppl.e19038","article-title":"NK\/T Cell Lymphoma in the U.S: A Population-Based Study Using the National Cancer Database from 1998\u20132012","volume":"34","author":"Karkera","year":"2016","journal-title":"J. Clin. Oncol."},{"key":"ref_15","unstructured":"(2021, April 10). Marginal Zone Lymphoma\u2014Lymphoma Research Foundation. Available online: https:\/\/lymphoma.org\/aboutlymphoma\/nhl\/mzl\/."},{"key":"ref_16","unstructured":"(2021, April 10). Melanoma Skin Cancer Statistics. Available online: https:\/\/www.cancer.org\/cancer\/melanoma-skin-cancer\/about\/key-statistics.html."},{"key":"ref_17","unstructured":"(2021, April 10). Lung Cancer Statistics|How Common Is Lung Cancer. Available online: https:\/\/www.cancer.org\/cancer\/lung-cancer\/about\/key-statistics.html."},{"key":"ref_18","unstructured":"(2021, April 10). Stomach (Gastric) Cancer Key Statistics. Available online: https:\/\/www.cancer.org\/cancer\/stomach-cancer\/about\/key-statistics.html."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1158\/1055-9965.EPI-08-0771","article-title":"Incidence of Ovarian, Peritoneal, and Fallopian Tube Carcinomas in the United States, 1995\u20132004","volume":"18","author":"Goodman","year":"2009","journal-title":"Cancer Epidemiol. Biomark. Prev."},{"key":"ref_20","unstructured":"(2021, April 10). Key Statistics for Bladder Cancer. Available online: https:\/\/www.cancer.org\/cancer\/bladder-cancer\/about\/key-statistics.html."},{"key":"ref_21","unstructured":"(2021, April 10). Key Statistics About Kidney Cancer. Available online: https:\/\/www.cancer.org\/cancer\/kidney-cancer\/about\/key-statistics.html."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"2542","DOI":"10.21037\/jtd.2018.05.72","article-title":"Esophageal Cancer in Patients under 50: A SEER Analysis","volume":"10","author":"Zeng","year":"2018","journal-title":"J. Thorac. Dis."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1053\/j.seminoncol.2018.07.001","article-title":"Epidemiologic Trends in Neuroendocrine Tumors: An Examination of Incidence Rates and Survival of Specific Patient Subgroups over the Past 20 Years","volume":"45","author":"Sackstein","year":"2018","journal-title":"Semin. Oncol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1002\/cncr.30246","article-title":"Impact of Country of Birth on the Age of Diagnosis of Hepatocellular Carcinoma in the United States","volume":"123","author":"Yang","year":"2017","journal-title":"Cancer"},{"key":"ref_25","unstructured":"(2021, April 10). Key Statistics for Endometrial Cancer. Available online: https:\/\/www.cancer.org\/cancer\/endometrial-cancer\/about\/key-statistics.html."},{"key":"ref_26","unstructured":"(2021, April 10). Key Statistics for Prostate Cancer|Prostate Cancer Facts. Available online: https:\/\/www.cancer.org\/cancer\/prostate-cancer\/about\/key-statistics.html."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"pkaa034","DOI":"10.1093\/jncics\/pkaa034","article-title":"Representativeness of Black Patients in Cancer Clinical Trials Sponsored by the National Cancer Institute Compared with Pharmaceutical Companies","volume":"4","author":"Unger","year":"2020","journal-title":"JNCI Cancer Spectr."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1091","DOI":"10.1002\/cncr.28575","article-title":"Twenty Years Post-NIH Revitalization Act: Enhancing Minority Participation in Clinical Trials (EMPaCT): Laying the Groundwork for Improving Minority Clinical Trial Accrual: Renewing the Case for Enhancing Minority Participation in Cancer Clinical Trials","volume":"120","author":"Chen","year":"2014","journal-title":"Cancer"},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"Parekh, T., and Desai, A. (2020). Demographic and Socioeconomic Disparities Among Cancer Survivors in Clinical Trials Participation, USA, 2016\u20132018. J. Cancer Educ.","DOI":"10.1007\/s13187-020-01790-6"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"674","DOI":"10.1634\/theoncologist.2015-0083","article-title":"Temporal Trends and Predictors for Cancer Clinical Trial Availability for Medically Underserved Populations","volume":"20","author":"Gerber","year":"2015","journal-title":"Oncologist"},{"key":"ref_31","unstructured":"(2021, April 09). NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research\u2014Updated 2 August 2000, Available online: https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-00-048.html."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"537","DOI":"10.1002\/onco.13749","article-title":"Prostate Cancer: Community Education and Disparities in Diagnosis and Treatment","volume":"26","author":"Carthon","year":"2021","journal-title":"Oncologist"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1038\/s41523-017-0039-1","article-title":"Video Intervention Increases Participation of Black Breast Cancer Patients in Therapeutic Trials","volume":"3","author":"Robinson","year":"2017","journal-title":"NPJ Breast Cancer"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1177\/107327481602300404","article-title":"Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients with Cancer","volume":"23","author":"Hamel","year":"2016","journal-title":"Cancer Control"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"2294","DOI":"10.1002\/cncr.33463","article-title":"The Impact of the Globalization of Cancer Clinical Trials on the Enrollment of Black Patients","volume":"127","author":"Tharakan","year":"2021","journal-title":"Cancer"}],"container-title":["Cancers"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6694\/13\/22\/5770\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T07:31:57Z","timestamp":1760167917000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6694\/13\/22\/5770"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,18]]},"references-count":35,"journal-issue":{"issue":"22","published-online":{"date-parts":[[2021,11]]}},"alternative-id":["cancers13225770"],"URL":"https:\/\/doi.org\/10.3390\/cancers13225770","relation":{},"ISSN":["2072-6694"],"issn-type":[{"value":"2072-6694","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11,18]]}}}